Research on the Mechanisms of Different Donors in Fecal Microbiota Transplantation for Treating Ulcerative Colitis
Phase: NA
Conditions: Inflammatory Bowel Diseases
Sponsor: First Affiliated Hospital of Kunming Medical University

 
 
 
 
Official TItle: 
Research on the mechanisms of different donors in 
fecal microbiota transplantation for treating 
ulcerative colitis 
 
 
Date: April 22, 2026  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
1. Background： 
Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), 
affects over 2 million people worldwide [1]. Although biological therapies have significantly 
improved the treatment outcomes for UC, nearly two-thirds of patients experience diminishing drug 
responses over time, making it crucial to explore novel therapeutic approaches targeting the 
underlying pathophysiology of UC. UC is associated with alterations in gut microbiota, reduced 
microbial diversity, and changes in the relative abundance of dominant bacterial populations. 
Specifically, UC patients exhibit a marked decrease in gut microbiota diversity at the species level, 
with a reduction in Firmicutes (e.g., Clostridium butyricum) and an increase in Actinobacteria, 
Proteobacteria (e.g., Escherichia coli), Enterobacteriaceae, Streptococcus, and Bacteroides [2]. 
Given the association between gut microbiota alterations and IBD activity, several studies [3-5] have 
proposed microbiota-based therapies, particularly fecal microbiota transplantation (FMT), as a 
treatment for UC. 
FMT involves the infusion of fecal material from healthy donors into patients to restore gut 
microbiota balance. It is currently recognized as an effective treatment for recurrent or refractory 
Clostridium difficile infections [6,7]. Numerous studies suggest that FMT, as a therapeutic tool to 
regulate gut microbial homeostasis, holds potential in treating UC and other diseases, although the 
biochemical and/or immune mechanisms underlying its effects remain unclear [8,9]. Paramsothy et 
al. [10] demonstrated the efficacy of autologous FMT compared to placebo, utilizing a protocol 
involving colonoscopy-guided FMT followed by daily enemas for 5 days per week over 8 weeks. 
However, the high financial burden of this approach limits its broader clinical application. Another 
study [11] revealed that donor FMT prepared anaerobically for 1-week treatment led to a higher 
likelihood of remission at 8 weeks compared to autologous FMT. Further research is needed to 
assess its safety and maintain long-term remission rates. 
Our team's high-quality research findings indicate that the gut microbiota of populations in 
Yunnan's ethnic minority regions exhibits significantly higher diversity and regional specificity 
compared to urban populations. This has potential value in enhancing FMT efficacy. Previous 
studies [12] revealed ethnic and regional differences in IBD prevalence in Yunnan Province, with 
lower rates among the Dai, Bai, and Miao ethnic groups compared to the Han population. An 
analysis of contributing factors highlighted the protective role of traditional ethnic diets, which 
increase gut microbial and viral diversity and probiotics content, thereby reducing UC prevalence. 
Based on this, the differences between donors in FMT may affect treatment outcomes, emphasizing 
the importance of identifying "high-quality" donors who maximize efficacy and minimize adverse 
reactions. 
 
2． Objectives: 
To investigate the impact of different donors (Han and Bai ethnic donors) on the efficacy of 
FMT in treating UC and identify “high-quality” donors. 
To isolate and culture key bacterial strains from Bai ethnic donors that contribute to their 
therapeutic effect. 
 
3. Results: 
   1.Primary Outcome: The primary outcome is a composite of steroid-free clinical remission 

together with endoscopic remission or response at week12, defined as a total Mayo score of ≤2 
points with no individual sub-score >1 point, and at least a 1 point reduction from baseline in the 
endoscopy sub-score (MES). 
   2.Secondary Outcomes: 
①Steroid-free clinical remission ( defined as a total Mayo score of ≤2 points with no 
individual sub-score >1 point ) 
②Steroid-free clinical response ( defined as a reduction of 3 points or more on the Mayo score, 
a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo 
sub-scores, or both ) 
③Steroid-free endoscopic response( defined as a Mayo endoscopy sub-score of 1 or less, with 
a reduction of at least 1 point from baseline ) 
④Variations in fecal microbiota composition, function, and metabolites at weeks 0, 1, 8, and 
12 within each group (Han donor group and Bai donor group) 
⑤Duration of microbiota recovery from baseline across weeks 0, 1, 8, and 12 within groups. 
⑥Intergroup differences in recipients’ microbiota composition between the Han and Bai donor 
groups. 
⑦Proportional contributions of recipient, donor, or mixed-origin microbiota in FMT recipients. 
⑧Dominant bacterial strains in highly effective cases of FMT treatment. 
 
4. Methods: 
1.Study Design: This is an open-label, single-center, non-randomized, parallel-group pilot clinical 
trial without a placebo control. Patients were allocated to either the Han donor FMT group or the 
Bai donor FMT group and followed up for a 12-week period. Subjects underwent follow-up 
assessments per the scheduled protocol: FMT administration at baseline, telephone follow-up at 
weeks 1 and 8, and an on-site follow-up visit at week 12. Subjects who discontinued participation 
or declined further follow-up were deemed to have completed the study, with no additional 
assessments arranged. 
Note: Single-center means all experimental activities are conducted at the same location. 
2.Study Population: 
Participants will be recruited through press conferences, advertisements, online social media 
platforms, health seminars, university campuses, public transportation stations, and clinics. 
Subordinates, students, or employees must input their respective institutional affiliations. Only 
participants with adequate time to complete the consent process and deliberate on participation will 
be enrolled. Participants voluntarily decide to participate without coercion from investigators. Non-
participation will not impact employment or academic status. 
Inclusion Criteria: 
（1）Age between 14 and 79 years (inclusive), any gender. 
（2）Diagnosed with ulcerative colitis (UC) per established clinical, endoscopic, and histological 
standards, with a disease duration of over 3 months. 
（3）Active mild-to-moderate UC, defined by a Mayo score of 4–10, including an endoscopic 
score ≥1 and a physician's global assessment score ≤2. 
（4）Stable baseline medication consisting of 5-aminosalicylic acid (mesalamine). 
（5）Signed written informed consent. 
Exclusion Criteria: 

（1）Participants unable to provide informed consent, answer questionnaires, or supply samples. 
（2）Pregnant women or those attempting to conceive. 
（3）Participants unwilling to use effective contraception throughout the study. 
（4）Participants deemed in remission by investigators. 
（5）Evidence or history of toxic megacolon. 
（6）Isolated rectal inflammation (<5 cm in extent). 
（7）Diagnosed with Crohn’s disease or indeterminate colitis. 
（8）Participants with perianal diseases (e.g., fistulae, anal fissures). 
（9）History of significant gastrointestinal surgery (e.g., colectomy) ： 
     -Minor surgeries will be reviewed case by case. 
     -Patients with appendectomy within 3 months will be excluded. 
（10）Antibiotic use within the past 4 weeks for any reason, including for UC. 
（11）Steroid dependence requiring >20 mg prednisone or >9 mg budesonide daily at enrollment. 
（12）Recent or anticipated usage of prohibited drugs during the study period, including: 
-Rectal corticosteroids within 2 weeks prior to the first FMT. 
-Biologics (e.g., infliximab, adalimumab, vedolizumab) within 4 weeks prior to the first 
FMT. 
-Other major immunosuppressants (e.g., calcineurin inhibitors, antitumor drugs) within 12 
weeks prior to treatment. 
-Probiotics within 4 weeks before the first FMT. 
-Experimental drugs or protocols within 12 weeks before the first FMT. 
-Anti-tuberculosis (TB or MAC) treatment within 4 weeks before the first FMT. 
 
Permitted Medications: 
  Participants may continue using the following medications if doses are stable within specified 
timeframes before the first FMT: 
-Oral 5-aminosalicylic acid (stable for 4 weeks). 
-Azathioprine and methotrexate (≥90 days of use with stable doses for 4 weeks). 
-Oral prednisone (≤20 mg/day, stable for 2 weeks, gradually tapered at a rate of 2.5 mg/week 
to discontinue by week 8). 
  Subjects should maintain the same doses of oral 5-aminosalicylates, thiopurines, and 
methotrexate during the study. For oral prednisolone, the dose had to be tapered off gradually, at a 
rate of 2.5mg per week, so that subjects were no longer exposed to steroids until week 8. 
Prohibited Medications: 
-Rectal corticosteroids (2 weeks before and throughout the study). 
-Antibiotics, antifungals, antivirals, probiotics, or prebiotics (4 weeks before and throughout 
the study). 
-Biologics or calcineurin inhibitors (12 weeks before and throughout the study). 
Participants using prohibited medications during the study will remain enrolled, and outcomes 
will still be evaluated. All prohibited medication usage will be recorded. 
 
3. Fecal Donor Recruitment          
Inclusion Criteria: 
(1) Age between 12 and 45 years (inclusive), any gender.     

(2) Body Mass Index (BMI) >18 and <25. 
(3) Written informed consent provided.             
Exclusion Criteria: 
Fecal Donation: 
(1) Individuals permanently disqualified from donating feces in other studies. 
(2) Individuals meeting any of the following criteria. 
Social Behavior: 
(3) Current or past smokers. 
(4) Current heavy alcohol consumers. 
Diet: 
(5) Currently adhering to a strict vegan diet. 
(6) Use of probiotic supplements in the past two months. 
  Occupation: 
(7) Occupations with high risk of blood-borne diseases. 
  Travel History: 
(8) Resided for at least six months in countries at high risk for Creutzfeldt-Jakob disease between 
1980 and 1996. 
(9) Traveled to areas with a high incidence of infectious diseases in the past six months. 
  Medical History: 
(10) History or presence of HIV, HTLV, hepatitis B or C, or other known infections. 
(11) History or presence of tuberculosis. 
(12) History of autoimmune diseases (e.g., connective tissue diseases, thyroid disorders, 
inflammatory arthritis, psoriasis, alopecia). 
(13) History of or concurrent atopic diseases (e.g., asthma, atopic dermatitis, eczema, eosinophilic 
gastrointestinal diseases). 
(14) History of cardiovascular or metabolic diseases (e.g., diabetes, hypertension, hyperlipidemia, 
hyperglycemia, heart disease, neurological disorders, fibromyalgia). 
(15) History of or concurrent neurological diseases (e.g., multiple sclerosis, Parkinson's disease, 
Alzheimer's disease, dementia). 
(16) History of chronic pain or chronic pain syndromes (e.g., chronic fatigue syndrome, 
fibromyalgia). 
(17) History of or concurrent cancer. 
(18) Clinically diagnosed psychiatric disorders or concurrent mental illnesses (e.g., depression, 
bipolar disorder, schizophrenia, eating disorders). 
(19) History of congenital or chronic liver diseases. 
 Gastrointestinal Disorders: 
(20) History of or concurrent celiac disease. 
(21) History of or concurrent inflammatory bowel disease (IBD). 
(22) History of or concurrent irritable bowel syndrome (IBS). 
(23) History of idiopathic chronic constipation or chronic diarrhea. 
(24) History of gastrointestinal malignancies or polyps. 
(25) History of rectal bleeding or concurrent rectal bleeding. 
  Medication Use: 
(26) History of using major immunosuppressants (e.g., calcineurin inhibitors, exogenous 

corticosteroids, biologics, anti-tumor necrosis factor agents, systemic chemotherapy). 
(27) History of growth hormone therapy. 
(28) Use of antibiotics within the past two months. 
(29) Participation in experimental drug or vaccine trials within the past two months. 
(30) Vaccination within the past month. 
(31) Use of proton pump inhibitors (PPIs) in the past two months. 
  Illegal Drug Use or Substance Abuse: 
(32) Intravenous drug use without a clinical prescription. 
(33) Use of illegal drugs. 
(34) Use of recreational drugs. 
Risky Sexual Behavior: 
(35) Engagement in sex work. 
(36) Sexual contact with sex workers. 
(37) Anonymous sexual encounters in the past 12 months. 
(38) Sexual contact with intravenous drug users in the past 12 months. 
(39) Sexual contact with men who have had sexual contact with other men in the past 12 months. 
(40) Male-to-male sexual behavior in the past 12 months. 
(41) History of sexually transmitted infections in the past 12 months. 
(42) Sexual contact with individuals confirmed to have HIV, HTLV, hepatitis, or syphilis in the past 
12 months. 
Other Behavior: 
(43) Previous imprisonment or detention in the past six months. 
(44) Tattoos or body piercings performed in the past six months. 
  Surgical History: 
(45) History of gastrointestinal surgery. 
(46) History of any organ transplantation (e.g., solid organ, bone marrow, cornea). 
  Family History: 
(47) First-degree relatives with IBD. 
(48) First-degree relatives diagnosed with colorectal cancer before age. 
  Screening Tests: 
(49) Abnormalities in any of the following screening tests: 
- Blood Tests: Complete blood count (CBC), biochemistry, ESR, CRP, hepatitis panel, HIV, 
syphilis, immunoglobulins and complement, T-SPOT, Torch 5, ANA/ANCA, EB DNA, and EB 
composite antibodies. 
- Stool Tests: Routine analysis, occult blood, parasites, worms (tapeworm, roundworm, 
hookworm, whipworm), schistosomes, Salmonella, Shigella, Clostridioides difficile (CDI), 
Helicobacter pylori (HP), and resistant bacteria (MDRA, MRSA, ESBL, CRE, VRE). 
- Urine Tests: Routine urinalysis and pregnancy test (if applicable for females). 
Potential fecal donors will be recruited from the general population. Candidates will complete 
an interview and screening questionnaire, followed by laboratory testing. Fecal samples will be 
collected only from donors who meet all eligibility criteria. 
 
 
5. Study Process: 

 
Groups  
 
1.FMT： 
Fresh fecal bacterial solution was obtained through the fecal bacterial transplantation isolation 
system (FMT-6A-50/12-AS, Nanjing), which was directly infused into the ileocecal region through 
the TET tube of colonoscopy within 30 minutes, 100 mL each time. The fresh fecal bacterial solution 
were given at an interval of one day for a total of 3 transplantations. 
 
2.Mayo Score： 
  The Mayo score is calculated according to Table 1, with clinical remission defined as a total Mayo 
score ≤2 and no individual subscore >1. 
                           Table 1 Mayo Score 
Item 
Score 
Evaluation 
1. Stool frequency a 
 
 
0 
Normal number of stools 
1 
1-2 more than normal 
2 
3-4 more than normal 
3 
≥ 5 more than normal 
2. Rectal bleeding b 
 
0 
No blood seen 
1 
Streaks of blood with stool in in less than half of 
the cases 
2 
Obvious blood with stools in most of the time 
3 
Blood alone passed 
3. Endoscopic findings 
0 
Normal mucosa or inactive disease 
1 
Mild activity ( erythema, decreased vascular 
pattern, mild friability ) 
2 
Moderate activity ( marked erythema, lack of 
vascular pattern, friability, erosions ) 
3 
Severe activity (spontaneous bleeding, large 
ulcerations) 
4. Physician’s global 
assessment 
0 
Normal c  
1 
Mild disease d 
2 
Moderate disease e 
3 
Severe disease f 
a Each patient serves as their own control to establish the degree of abnormal stool frequency. 
    b The daily rectal bleeding score represents the most severe bleeding observed on a single day.     
    c No symptoms of colitis; the patient feels well, with a flexible sigmoidoscopy score of 0. 
    d Mild symptoms with mild abnormalities observed on sigmoidoscopy; primarily scored as 1. 
    e More severe abnormalities, with sigmoidoscopy and symptom scores between 1 and 2. 
f Sigmoidoscopy and symptom scores of 2 to 3, where the patient may require corticosteroid 
treatment and hospitalization. 
Groups 
Fresh fecal bacterial solution 
(Ethnic Han Donor) 
Fresh fecal bacterial 
solution 
(Bai Ethnic Donor) 
Planned enrollment 
50 Patients 
50 Patients 
Planned completed 12-week 
follow-up 
30 Patients 
30 Patients 

Note: A score of ≤2, with no individual subscore >1, indicates clinical remission. A score of 
3–5 indicates mild activity, 6–10 indicates moderate activity, and 11–12 indicates severe 
activity. 
3. Clinical Laboratory Tests 
Blood samples will be collected for testing, including complete blood count (CBC), blood 
biochemistry, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). 
4. Histological Assessment 
Colon biopsies will be performed during colonoscopy for histological evaluation. 
5. Assessment Schedule (Table 2 ) 
1. Screening and Group Assignment Visit (-21 Days to Day 0) 
For all consenting patients, baseline demographic and clinical information was collected prior 
to group assignment, including: Age, gender, and smoking status (current smoker, former smoker, 
or non-smoker). 
(1) Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or other anticoagulants. 
(2) Use of proton pump inhibitors (PPIs), H2 receptor blockers (H2RB), or other antacids. 
(3) Presence of primary sclerosing cholangitis (PSC). 
(4) History of appendectomy. 
(5) Duration and severity of ulcerative colitis (UC). 
(6) Current treatments and medications. 
(7) Self-reported medication adherence. 
Eligible participants were then non-randomly allocated in a 1:1 ratio to two parallel groups to 
receive FMT from either a Han donor or a Bai donor. 
2. Treatment and Follow-Up (Week 0 to Week 12) 
Participants will undergo two colonoscopies with biopsies performed at two time points: before 
treatment,at 8–12 weeks post-FMT 
Stool samples will be collected at the following times: before treatment, at the end of FMT 
treatment, 8 weeks post-FMT, 12 weeks post-FMT. 
During each visit, Mayo scores (including endoscopic subscoring) were evaluated by blinded 
outcome assessors. Biopsies were performed for histological assessments, and histological scoring 
was conducted by a blinded pathologist. A dedicated telephone line was available for patients to 
report any adverse events or worsening of symptoms between scheduled visits. This was an open-
label trial; patients and treating physicians were aware of group allocation, while endoscopists, 
pathologists, and outcome assessors remained fully blinded to group assignments to minimize 
assessment bias. 
 
 
 
 
 
 
 
 
 
 

 
 
                                 
 
 
Sample collection plan 
Study visit (day/week) 
Screening  & 
Vist (Day) 
Treatment & Follow 
&Up 
(Week) 
Treatment & 
Follow &Up 
(Week) 
Treatment & 
Follow &Up 
(Week) 
-21 to 0 
1 
8 
12 
Window period (day) 
0 
0 
 
 
Informed consent 
x 
 
 
 
Inclusion and exclusion criteria 
x 
 
 
 
Demographics 
and 
medical 
history 
x 
 
 
 
Pregnancy test (if applicable) 
 
x 
x 
 
 
Infusion of FMT 
 
Xxx 
（The Bacterial 
solution was given at 
an interval of one 
day, and a total of 
100 mL was 
transplanted 3 
times） 
 
 
Mayo score (including MES)  
x 
 
x 
Clinical laboratory test 
x 
x 
x 
Fecal calprotectin 
x 
x 
x 
x 
Adverse.events/serious adverse 
events 
 
x 
x 
x 
 

Follow-up Time Points 
 
  
Groups 
（40 Patients/Group) 
Samples 
Before FMT（ Day ） 
 Follow Up ( Week )  Follow Up ( Week ) 
 Follow Up ( Week ) 
Baseline(0) 
1 
8 
12 
Fresh fecal bacterial solution 
(Normal /Ethnic Han Donor) 
Stool 
√ 
√ 
√ 
√ 
Biopsies 
√ 
 
  
√ 
Food Record Questionnaire 
√ 
√ 
√ 
√ 
Fresh fecal bacterial solution 
( Bai Ethnic Donor) 
Stool 
√ 
√ 
√ 
√ 
Biopsies 
√ 
 
  
√ 
Food Record Questionnaire 
√ 
√ 
√ 
√ 

Note: (The procedures of sample collections and subpackaging are as follows) 
①Study stool: The stool of patients are collected and packed into 2ml cryogenic vials. 
②Study biopsies: One piece was selected from the ileocecal region and two pieces were taken from 
the most severe lesion of the rectum (10cm from the anus) and placed in a 2ml cryopreserved tube. 
 
7. Group Assignment, Open-Label Design, and Treatment Protocols: 
1. Group Assignment: 
   Eligible subjects were non-randomly allocated in a 1:1 ratio to two parallel groups to receive 
FMT from either a Han donor or a Bai donor, based on clinical feasibility and donor availability.  
2. Open-Label Design: 
   This was an open-label trial, so both treating physicians and study participants were fully aware 
of the donor type (Han or Bai) assigned for FMT treatment throughout the study. 
3. Treatment Protocol in Emergency Situations: 
   In cases of medical emergencies requiring urgent clinical care, appropriate medical management 
was provided promptly to participants. Since this was an open-label study, no unblinding procedures 
were needed. All participants completed scheduled follow-up through week 12 unless they 
voluntarily withdrew from the study. 
 
8. Research Samples 
1. Sample Collection and Storage 
All samples will be stored at -80 ℃. 
2. Sample Analysis 
Fecal Calprotectin 
Once sufficient fecal samples are collected, QUANTA Lite calprotectin ELISA will be used to 
measure fecal calprotectin concentrations in batches. This is an enzyme-linked immunosorbent 
assay (ELISA) system based on a colorimetric detection of polyclonal antibodies to calprotectin. 
The ELISA range is 10–1800 mg/g, requiring a sample volume of 50–150 mL. The assay 
sensitivity is less than 10 mg/g. Analysis of the treatment arms will be performed in a blinded 
manner.    
  Microbial Analysis 
(1) Nucleic Acid Extraction 
According to the protocol, DNA will be extracted from the study samples using the Maxwell® 
RSC PureFood GMO and Authentication Kit. Fecal pellets will first be mixed with CTAB buffer 
and vortexed, followed by heating for 5 minutes. Proteinase K and RNase A will then be added to 
the sample, which will be incubated at 70 ℃. After centrifugation, the supernatant will be collected 
and transferred to the Maxwell® RSC instrument for further processing. 
(2) Microbiome and Metabolomics Analysis 
  Collected specimens will undergo laboratory microbial analysis, including the identification of 
bacterial, viral, and fungal components in the human microbiome. DNA will be enriched and 
extracted using different kits, such as the Qiagen QIAamp® DNA Mini Kit, Qiagen QIAamp DNA 
Stool Mini Kit, Mobio UltraClean® Tissue & Cells DNA Isolation Kit, and Maxwell® RSC 
PureFood GMO and Authentication Kit. Subsequent metagenomic sequencing will be performed 
using the Novoseq 6000 system (2x300 bp paired-end reads). Bacterial, fungal, and viral analyses 
will be conducted using methplan2, UNITE2-Bowtie2, and Kraken2, respectively. To compare 

differences in microbiome, metabolome, and meta transcriptome configurations among treatment 
groups, donors, and specimens at different time points, statistical tools such as DESeq, Random 
Forest, LEfSe linear discriminant analysis and MasSlin2 will be used. DESeq and Random Forest 
will be executed in R, while Lefse analysis will be performed on the Huttenhower Lab Galaxy server 
(http://huttenhower.sph.harvard.edu/). DB-RDA analysis in R will describe the effects of clinical 
factors on multivariate datasets. 
Animal Studies 
Biological samples collected in this study can be used for animal research. For example, fecal 
samples from FMT donors and recipients can be orally administered to animal models to study 
microbiome effects. 
3. Subsequent Handling of Specimens 
Original specimens and derivative materials will be stored for up to 10 years. Specimens may 
be shipped abroad for analysis or used for research on the gut microbiome. Data generated from this 
project, including genetic, metagenomic, metabolomic, microbiome, and clinical information, will 
have all personal identifiers removed (de-identified) and stored in a secure electronic database, such 
as the Genotype and Phenotype (dbGaP) database managed by the National Institutes of Health 
(NIH), the Sequence Read Archive (SRA) at NIH, or academic institutions like the Li Ka Shing 
Health Sciences Research Institute at The Chinese University of Hong Kong or the Wellcome 
Sanger Institute. Only qualified researchers with institutional or employer support will have access 
to these data. These researchers will be required to agree not to attempt re-identification of the 
donors from the genetic information. 
9. Withdrawal Procedures 
Participants may withdraw from the study at any time without affecting their access to standard 
medical care. No further data or samples will be collected after withdrawal. However, any 
previously collected samples or data that have been processed or uploaded to the databases cannot 
be deleted, and data already downloaded by qualified researchers cannot be retrieved. 
10. Sample Size 
The study includes 50 UC recipients for FMT from Bai donors and 50 UC recipients for FMT 
from Han donors, totaling 100 participants. 
11. Statistical Analysis 
Continuous variables will be expressed as means (SD) and compared between groups using 
unpaired t-tests. Categorical variables will be compared using the chi-square test or Fisher's exact 
test. A modified intent-to-treat analysis will include all participants who have received at least one 
FMT treatment. Participants requiring additional treatments, violating the study protocol, failing to 
discontinue corticosteroids by week 8, or discontinuing the study for any reason will be considered 
treatment failures. Per-protocol analysis will include participants who completed the 8-week blind 
treatment course without protocol violations. Missing data will be imputed using the last observation 
carried forward (LOCF) method, where missing values are replaced with the last observed value. A 
two-sided p-value of <0.05 will be considered statistically significant. Safety data will be 
summarized using descriptive statistics. All statistical analyses will be performed using R (4.0.5). 
12. Potential Risks 
There is a potential risk of perforation during colonoscopy, but the overall incidence of 
complications is less than 1%. The risk of infectious diseases during fecal microbiota transplantation 
(FMT) is minimal due to rigorous donor screening prior to transplantation. To date, FMT appears 

to be safe. Over 200 FMT procedures have been conducted at the Academic Medical Center in 
Amsterdam and more than 3,000 at the Digestive Disease Center in Sydney, Australia, without any 
reports of serious adverse events. Mild adverse reactions such as bloating, flatulence, borborygmi, 
vomiting, and abdominal discomfort may occasionally occur. Only qualified researchers have access 
to de-identified data in the database. Furthermore, they agree not to use this information to attempt 
to identify the data providers, ensuring participant confidentiality. However, given the availability 
of current public-domain technologies and expected advancements in the coming years, identifying 
specific individuals from genetic or other information may become feasible and increasingly 
straightforward. Participants and their family members may face potential risks (e.g., those related 
to insurance, employment, cybersecurity breaches, and law enforcement) due to shared genetic 
characteristics. 
13. Pregnancy 
All women of childbearing potential, except postmenopausal or sterilized women, are required 
to undergo pregnancy testing. Women of childbearing potential must use contraception throughout 
the study. If a female participant becomes pregnant during the study, she must immediately notify 
the research team. In such cases, the participant will be withdrawn from the study. If feasible, an 
early termination visit will be scheduled after pregnancy confirmation. 
14.  Non-return of Research Results 
The results of microbiome analyses will not be returned to participants. In other words, this 
data will not be used to influence the clinical care received by participants or their genetically related 
family members. The potential benefit of this study lies in improving care and management in the 
future. 
15. Costs, Expenses, and Compensation 
To assist participants with costs related to research participation, including travel and other 
expenses, fecal microbiota transplantation (FMT) will be provided free of charge during each 
required study visit. The total cost of the three FMT procedures is estimated to be 18,000 RMB. 
16. Consent and Withdrawal 
Participants may withdraw from the study at any time without affecting their standard medical 
care. Any samples collected from the participant may be destroyed upon request. However, de-
identified data already entered the database cannot be deleted, nor can data already downloaded by 
authorized researchers be retrieved. Withdrawal from the study will not in any way affect the 
participant's access to medical care, and they will continue to receive healthcare services from our 
hospital. 
17. Adverse Events (AEs) 
1. Severity Levels 
   The severity of adverse events (AEs) will be graded on a scale of 1 to 5. 
2. Collection and Reporting 
The collection of AEs, including serious adverse events (SAEs), will begin from the first 
administration of FMT. Routine AE collection will continue until week 1.Since participants will 
transition to standard care after week 1, AEs occurring beyond this period will not be collected. 
Anticipated Clinical Events Following FMT 
FMT is known to be associated with certain characteristic signs and symptoms (listed below). These 
symptoms are typically mild and resolve within three days post-FMT. Unless symptoms persist for 
more than three days or become more severe, they will not be recorded as AEs.

 
UC is associated with certain characteristic signs and symptoms, including diarrhea, rectal 
bleeding, and abdominal pain. These signs and symptoms may be present at baseline and can persist 
or fluctuate throughout the study based on the subject's medical history. These signs and symptoms 
will not be collected as AEs. However, an exacerbation of disease activity (e.g., an increase in daily 
rectal bleeding or abdominal pain beyond the subject’s normal fluctuations, or the emergence of 
new signs and symptoms of UC) will be collected as AEs and reported in accordance with regulatory 
requirements. Extraintestinal manifestations of UC (e.g., joint pain, arthritis, uveitis) that develop 
or worsen during the study will also be considered AEs. 
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118.e4. 
9. 
Moayyedi P, Surette MG, Kim PT, et al. Fecal Microbiota Transplantation Induces Remission in 

Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 
2015;149(1):102-109.e6. 
10. Paramsothy S, Kamm MA, Kaakoush NO, et al. Multidonor intensive faecal microbiota 
transplantation for active ulcerative colitis: a randomised placebo- controlled trial. The Lancet. 
2017;389(10075):1218-1228. 
11. Costello SP, Hughes PA, Waters O, et al. Effect of Fecal Microbiota Transplantation on 8-Week 
Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial. JAMA. 
2019;321(2):156-164.  
12. Sun Y, Zuo T, Miao Y, et al. Population-Level Configurations of Gut Mycobiome Across 6 
Ethnicities in Urban and Rural China. Gastroenterology. 2021 Jan;160(1):272-286. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

19. Clinical study approval document issued by the Ethics Committee of the First Affiliated 
Hospital of Kunming Medical University 
              
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Clinical study approval document issued by the Ethics Committee of the First Affiliated Hospital of Kunming Medical University 
                                                                  (2025)  Lun L No.111 
Projec t Name 
Research on the mechanisms of different donors in fecal microbiota transplantation for treating ulcerative 
colitis (Mechanism and clinical study of fecal bacteria transplantation for inflammatory bowel  disease) 
Application Authority(person) 
The First Affiliated Hospital of Kuming Medical University  
Undertake the Department 
Department 
of 
gastroenterology 
Principal 
investigator 
According 
to 
should ray Yang 
Sun 
Professional 
ranks and titles 
Associate Chief 
Physician 
Source of research funds 
□Government  □ Foundation  □Company  □International Co-operation 
■Others(please indicate)  Yunnan Clinical Research Center for Digestive System Diseases 
Send review documents 
1.Study protocol(Version No:1.0. Date:March 13,2025) 
2.Informed Consent Form(Version No:1.0. Date:March 13,2025) 
3.Case Report Form(Version No:1.0. Date:March 13,2025) 
4.CV of investigator and GCP certificate 
Ethical review methods 
□Conference Review 
■Quick Review 
juror 
Hao Qinglin and Zhang Ling 
Review comments form the Ethics 
Committee 
Agreed to proceed the center 
The responsibilities, composition, operating procedures, and records of this Ethics Committee comply with ICH-GCP and relevant laws and 
regulations of China. 
Matter need attention: 
1. This clinical trial shall be commenced within 1 year from the date of approval granted by the Ethics Committee. Failure to initiate the trial 
within this time limit shall result in automatic expiration of this Approval Letter. 
2. The research shall be conducted in accordance with the protocol approved by this Ethics Committee, and shall comply with the principles of 
CFDA/GCP and the Declaration of Helsinki. 
3. From the date of approval, periodic continuing review shall be conducted every 12 months (the review frequency may be adjusted based on 
actual progress): Please submit the Continuing Review Form to the Ethics Committee 1 month prior to the scheduled review date. 
4. During the course of the research, any modifications to the study protocol, informed consent form, or other related documents must be submitted 
with the Amendment Application Form and the relevant materials specified in the “Checklist of Submission Documents.”Such amendments may 
only be implemented after review and approval by the Ethics Committee. 
5. In the event of a serious adverse event (SAE) or an unexpected adverse event affecting the risk-benefit ratio of the study, written notification 
must be submitted to the Ethics Committee concurrently with the report to the CFDA. The CFDA Serious Adverse Event Report Form, or the 
Serious Adverse Event/Unexpected Adverse Event Report Form published by this Ethics Committee, or other equivalent reporting forms with 
relevant content may be used; however, reports in foreign languages must be accompanied by a Chinese summary. The Ethics Committee reserves 
the right to make new decisions based on its assessment. 
6. Instances of non-compliance or protocol violations must be promptly reported using the Non-compliance/Protocol Deviation Report Form. 
7. Premature termination of the study must be promptly reported by submitting the Study Termination Report Form. 
8. Upon completion of the study, the Study Closure/Completion Report Form must be submitted. 
9. Prompt written notification of significant decisions made by other Ethics Committees is required. 
Signature of Chairperson or Vice-Chairperson: 
 
Ethics Committee of the First Affiliated Hospital of Kunming Medical University (Seal) 
2025, August 25 
Address : No.295, Xichang  Road, Kunming,  Yunnan  province :  650032  Tel :  0871-65328584  Contact :  Wang  Ting 

The First Affiliated Hospital of kunming Medical university 
Informed consent form for microflora transplantation 
(FMT/miniFMT) 
 
surname and personal name:        administrative or technical offices: 
Bed number:          Bed Hospitalization Number:            Date: 
   
Disease conditions and treatmen t recommendations: 
   1. Basic information of the patients: 
   diagnose:                                                               
   age:         Gender:         Allergic history:         
Pregnancy history: □ with  □ with no 
Number of previous FMT treatments:        (times), with or without adverse 
effects: □ have  □ have no 
FMT pre-treatment examination: 
ALT       U/L;  AST       U/L; CRP       mg/L; ESR        mm; 
EB-DNA        Copy/ml; HCMV-DNA        Copy/ml; 
Stool routine +occult blood:[]; 
HbsAg[    ]; Anti-HBs[    ]; HbeAg[    ]; Anti-Hbe[    ]; Anti-Hbc[    ]; 
Anti-HCV[      ]; Anti-HIV1/2[      ]; Syphilis:[      ]; Others:[      ] 
2. Treatment recommendations 
I have obtained the following explanations: microflora transplantation includes 
fecal bacteria transplantation (FMT) and formula microflora transplantation (mini FMT 
or SMT), the indications for microflora transplantation, foreign and domestic 
applications and research status, the benefits for the diagnosis and treatment of diseases, 
the chances of surgical (or regimen) treatment success, 
Including: the benefits of functional intestinal flora reconstruction, the recent 
improvement or cure probability of the disease, the long-term evolution of the disease, 
different diseases and no differences in efficacy of the same subcategory of diseases, 
odds of success during treatment, and changes in efficacy during follow-up. The doctor 
has told me that I have one                                             , 
Depending on the condition, faecal bacteria transplantation (FMT / mini FMT) 
treatment can be performed. 
 
 
Our hospital has clearly informed the patient(close relatives/guardians) of the 
following contents: 
(1) Although doctors have tried to eliminate possible risks, there may still be the risk of  
disease infection, "window period" problems that cannot be detected, wrong test results, 
and unpredictable risks; formula flora transplantation may also have unpredictable risks. 
(2) Possible main risks and complications in the process of microflora transplantation 
and related diagnosis and treatment, including failure of operation, perforation, 

bleeding, abdominal infection, etc. In case of occurrence, agree to the doctor to give the 
corresponding diagnosis and treatment disposal. 
(3) After the microflora transplant, my disease may be cured, partially effective, 
recurrent, or recurrent. Repeat implementation of microflora transplantation therapy 
may be required. I can choose to abandon this treatment strategy at any stage. 
(4) For the diagnosis and treatment needs of the condition, the members of the diagnosis 
and treatment team can implement relevant alternative diagnosis and treatment 
measures. 
 
 
patients(close relatives/guardians) include the following contents: 
(1) I agree to and authorize it                (Physician signature) And its diagnosis 
and treatment team to implement the following possible options: via colonoscopy, on 
Gastrointestinal endoscopy, middle gastrointestinal endoscopy, gastric tube, 
nasojejunal tube, enema, oral capsule containing intestinal bacterial fluid, fistula tube, 
rectal graft tube (TET) (the involved endoscopy and anesthesia informed consent were 
signed separately). 
(2) The type of transplanted bacteria I received was: □ fresh fecal bacteria □ frozen 
fecal bacteria □ formula bacteria. 
(3) For faecal bacteria transplantation, I agree that the source of faecal bacteria is: □ 
relatives □ friends □ Other healthy people, as suggested by the doctor. For formula flora 
transplantation, I knew that the group selection was determined by the doctor. 
(4) I agree that the hospital will preserve and use my fecal bacteria, body fluids and 
tissue specimens for teaching and medical research without involving personal 
identifiable information and privacy. 
(5) Each doctor and patient s hall hold one copy of this informed consent. I have been 
told that the property right of this document belongs to the institute and shall not be 
issued and distributed without permission. 
(6) After full notification, I have read or passed my relatives have read and 
explained the above content, and I hereby sign the informed consent form. 
 
 
patients(close relatives/guardians)carefully promisethat: 
 
Patient (close relative / guardian) signature: Relationship: Time:   year   moon     
sun 
 
Doctor Signature: Time:   year   moon   sun 
 
 
 
 
The First Affiliated Hospital of kunming Medical university 

Informed consent form for microflora transplantation 
(FMT/miniFMT) 
 
surname and personal name:        administrative or technical offices: 
Bed number:          Bed Hospitalization Number:            Date: 
   
    
 
 
Commitment content 
(I) My name is XXX, and I have understood the process and related risks 
of fecal transplantation. I strongly require fecal transplantation treatment, 
and I am willing to take all the risks. 
 
 (Family member) I am XXX from XXX. I have understood 
the process and related risks of fecal transplantation, so I 
strongly demand the treatment of fecal transplantation, and I am willing to 
take all the risks.