Clinical trial NCT04890405: Clinical Study of Selective Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome.
Official title: Clinical Comparative Study of Precision Flora Transplantation and Standardized Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome Variant of Childhood
Keywords: irritable bowel syndrome
diarrhea
Fecal Microbiota Transplantation
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Diarrhea-type irritable bowel syndrome patients were randomly divided into 2 groups, and each group was given a different treatment method
Primary purpose: TREATMENT

Brief summary: In order to seek a more precise and convenient treatment, we made a self-made precise transplant capsule that is effective against diarrhea. Compared with standardized fecal microbiota transplantation transplantation on the treat of diarrhea-type irritable bowel syndrome. To observe the similarities and differences of the effect between the two treatment methods on the disease. and the changes in intestinal bacteria was also observed.

Detailed description: In order to clarify the effectiveness of precision fecal bacteria transplantation, we have independently developed precision transplantation capsules. Seventy patients with diarrhea-type irritable bowel syndrome were selected and randomly divided into 2 groups. The patients in the first group were treated with standard fecal bacteria transplantation once, and the patients in other group were treated with precision transplantation capsules for 28 days. The clinical symptoms of the patients of the two groups were observed before and 2, 4, 8, 12, 24, and 48 weeks after the treatment, and stool samples were collected for intestinal flora detection. The purpose is to observe and compare the efficacy of the two treatment methods and their influence on the intestinal flora.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 \~ 75 years.
* Patients who meet the diagnostic criteria of Rome IV of Irritable Bowel Syndrome and are definitely diagnosed as IBS-D.
* IBS has been diagnosed for more than 6 months, and has been treated with conventional drugs without obvious curative effect or repeated attacks.
* No other serious diseases, no mental disorders, and normal communication skills.
* Sign informed consent and agree to participate in this study.
* No antibiotics and probiotics were used within one month.

Exclusion Criteria:

* Patients are unwilling to participate in this study.
* Other serious diseases of heart, liver, kidney, respiration, digestion, blood and endocrine system.
* Combined with intestinal double infection, such as CDI, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, plague, cytomegalovirus, etc.
* Liver function is significantly abnormal or has the following history of liver disease: AST or ALT is higher than 2 times of the upper limit of normal value, history of liver cirrhosis and hepatic encephalopathy, history of esophageal varices or history of portal shunt.
* There is evidence of renal function damage or the following history of kidney disease: serum creatinine is 1.5 times higher than the upper limit of normal value; History of dialysis; Or a history of nephrotic syndrome.
* Patients with various acute infections, tumors, severe arrhythmia, mental system disorders, and drug or alcohol addicts.
* History of abdominal surgery (except appendicitis, cholecystitis, caesarean section and hysterectomy).
* Those who were allergic to capsule drugs or contraindications.
* Lactose intolerance.
* Clinical researchers who are engaged in other related irritable bowel syndrome at the time of enrollment or within 3 months before enrollment.
* It is difficult to complete the follow-up, or various factors affecting the compliance.
* Pregnant or lactating women.

Primary outcomes:
measure: IBS-SSS score
timeFrame: 12 Week after treatment
Secondary outcomes:
measure: Clinical remission rate
timeFrame: 2、4、8、12 Week after treatment
measure: GSRS score
timeFrame: 0、2、4、8、12Week after treatment
measure: IBS-QoL score
timeFrame: 0、2、4、8、12Week after treatment
measure: PHQ-9
timeFrame: 0、2、4、8、12Week after treatment
measure: GAD-7
timeFrame: 0、2、4、8、12Week after treatment
measure: SAS
timeFrame: 0、2、4、8、12Week after treatment
measure: SDS
timeFrame: 0、2、4、8、12after treatment
measure: Intestinal flora
timeFrame: 0、2、4、8、12Week after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Army Medical Center of PLA
name: Yanling Wei
role: PRINCIPAL_INVESTIGATOR
References: