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ICEBOAT. A prospective, multi-center, double blind randomized trial of fecal microbiota transplantation (FMT) delivered by capsule versus placebo in severe irritable bowel syndrome (IBS)
EU CTIS ID: 2024-516099-13-00
What this study is testing
To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks in patients with irritable bowel syndrome with severe disease refractory to conventional treatments
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >= 18 years and < 75 years
- IBS defined according to Rome IV definition (IBS-C, IBS-D or IBS-M)
- Severe disease (IBS-SSS >300) and refractory to at least two previous treatment strategies
- Patient with health insurance (AME excepted)
- Informed Written consent
- For women with childbearing potential, efficient contraception for the duration of the participation to the study
You likely can't join if
- Other gastrointestinal disease (celiac disease, inflammatory bowel disease)
- Presence of systemic disease, immune deficiency or treatment with immune-modulating Medication
- Severe psychiatric disorder
- Participants who were assessed as likely to be noncompliant (ie, not adhering to the tasks they were to perform as participants)
- Participants if there is a reason to suspect an alternative diagnosis to the IBS complaints
- Surgical intervention in the gastrointestinal region except for appendectomy, hernia repair, cholecystectomy and hemorroidectomy
See the full eligibility criteria
- Age >= 18 years and < 75 years
- IBS defined according to Rome IV definition (IBS-C, IBS-D or IBS-M)
- Severe disease (IBS-SSS >300) and refractory to at least two previous treatment strategies
- Patient with health insurance (AME excepted)
- Informed Written consent
- For women with childbearing potential, efficient contraception for the duration of the participation to the study
- Other gastrointestinal disease (celiac disease, inflammatory bowel disease)
- Presence of systemic disease, immune deficiency or treatment with immune-modulating Medication
- Severe psychiatric disorder
- Participants who were assessed as likely to be noncompliant (ie, not adhering to the tasks they were to perform as participants)
- Participants if there is a reason to suspect an alternative diagnosis to the IBS complaints
- Surgical intervention in the gastrointestinal region except for appendectomy, hernia repair, cholecystectomy and hemorroidectomy
- Treatment preceding FMT with antibiotics, antifungic or probiotics treatment < 4 weeks, or factors that may affect the composition of intestinal microbiota
- Abuse of alcohol or drugs
- Pregnancy or breastfeeding
- Participation in any other interventional study
- Patients under legal protection
- Acute COVID-19 infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.