Clinical trial NCT05740319: Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Official title: Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.

Detailed description: This prospective, single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients. Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times. The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube. The patients receive treatment once a month and will be followed up for 3 months. Improvement in IBS symptoms, emotion and quality of life were assessed through IBS symptom severity scale (IBS-SSS), Gastrointestinal symptom rating scale (GSRS), IBS-Global Assessment of Improvement (IBS-GAI), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS) and IBS-Quality of Life (IBS-QoL) respectively. Patients were asked to complete these scales and collect fecal samples at baseline, post-FMT and at 1, 2, 3 and 4 months after FMT. Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT. Secondary endpoints include Change in GSRS score, improvement in emotion and quality of life at post-FMT, 1 and 6 months, as well as change in fecal microbiota composition.

Eligibility criteria: Inclusion Criteria:

* Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
* Patients who have experienced failure of at least 3 conventional therapies for IBS;
* Absence of red flags such as weight loss, hematochezia;

Exclusion Criteria:

* Pregnant, planning pregnancy or lactating;
* Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
* Immunodeficiency or treatment with immune-modulating medication;
* Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
* Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
* Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
* Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;

Primary outcomes:
measure: Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks
timeFrame: at baseline and 9 weeks
measure: Response rate at 9 weeks
timeFrame: at 9 weeks
Secondary outcomes:
measure: Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months
timeFrame: at baseline, 1 week, 1 month and 6 months
measure: Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months
timeFrame: at baseline, 1 week, 1 month, 9 weeks and 6 months
measure: Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months
timeFrame: at baseline, 1 month, 3months and 6 months
measure: Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months
timeFrame: at baseline, 1 month, 3months and 6 months
measure: Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months
timeFrame: at baseline, 1 month, 3months and 6 months
measure: Response rate at 1 week, 1month, 3 months and 6 months
timeFrame: at 1 week, 1month, 3 months and 6 months
measure: Change from baseline fecal microbiota composition at 1 week, 1 month and 6 months
timeFrame: at baseline, 1 week, 1 month and 6 months
measure: Change from baseline fecal metabolites at 1 week, 1 month and 6 months
timeFrame: at baseline, 1 week, 1 month and 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ling Dong
role: PRINCIPAL_INVESTIGATOR
References: