Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Recruiting
N/AInterventional Study
Irritable Bowel Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
102 (estimated)
Sponsor
Shanghai Zhongshan Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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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 pr…
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;
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