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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FMT

Participants will be given FMT through oral capsules or nasojejunal tube once a month for three months.

Group Type EXPERIMENTAL

FMT

Intervention Type OTHER

FMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.

Interventions

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FMT

FMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes