Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Fudan University

Status

Enrolling

Conditions

Irritable Bowel Syndrome

Treatments

Other: FMT

Study type

Interventional

Funder types

Other

Identifiers

NCT05740319

B2022-507R

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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;