Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FMT.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other FMT
FMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.
Primary outcome measures
- Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks [Time frame: at baseline and 9 weeks]
- Response rate at 9 weeks [Time frame: at 9 weeks]
Secondary outcome measures (8)
- Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months [Time frame: at baseline, 1 week, 1 month and 6 months]
- Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months [Time frame: at baseline, 1 week, 1 month, 9 weeks and 6 months]
- Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months [Time frame: at baseline, 1 month, 3months and 6 months]
- Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months [Time frame: at baseline, 1 month, 3months and 6 months]
- Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months [Time frame: at baseline, 1 month, 3months and 6 months]
- Response rate at 1 week, 1month, 3 months and 6 months [Time frame: at 1 week, 1month, 3 months and 6 months]
- Change from baseline fecal microbiota composition at 1 week, 1 month and 6 months [Time frame: at baseline, 1 week, 1 month and 6 months]
- Change from baseline fecal metabolites at 1 week, 1 month and 6 months [Time frame: at baseline, 1 week, 1 month and 6 months]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT05740319 · B2022-507R