A prospective, multi-center, double blind randomized trial of fecal microbiota transplantation (FMT) delivered by capsule versus placebo in severe irritable bowel syndrome (IBS) - ICEBOAT (Ibs CapsulE microBiOtA Transplantation)

A prospective, multi-center, double blind randomized trial of fecal microbiota transplantation (FMT) delivered by capsule versus placebo in severe irritable bowel syndrome (IBS) - ICEBOAT (Ibs CapsulE microBiOtA Transplantation) - ICEBOAT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003433-41-FR

Enrollment

150

Registered

2023-01-31

Start date

2023-08-30

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with severe Irritable Bowel Syndrome (IBS) diagnosed MedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: Fecal Microbiota Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age >= 18 years and 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Other chronic gastrointestinal disease (celiac disease, inflammatory bowel disease) - 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 - Contraindication to fecal transplantation

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: 1.To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks i 2.FMT success: patient’s microbiota 12 weeks after FMT closer to that of the donor than the patient’s microbiota before FMT. 3.Intestinal microbiota composition at week 12 and 24 4.Efficacy (decrease in IBS severity >75 points) according to FMT success. 5.Efficacy according to FDA on composite criteria at 12 or 24 weeks 6.IBS severity at 12 weeks by donors (one donor giving FMT to several patients) 7.IBS severity at 12 weeks and at 24 weeks by IBS subtypes according to transit pattern IBS severity 8.IBS Quality of life at 12 weeks and 24 weeks 9.Patient’s perception of FMT 10. Secondary effects of FMT. ;Primary end point(s): Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS.;Timepoint(s) of evaluation of this end point: 12 semaines après FMT	—

Measure

Time frame

Main Objective: 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;Secondary Objective: 1.To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks i 2.FMT success: patient’s microbiota 12 weeks after FMT closer to that of the donor than the patient’s microbiota before FMT. 3.Intestinal microbiota composition at week 12 and 24 4.Efficacy (decrease in IBS severity >75 points) according to FMT success. 5.Efficacy according to FDA on composite criteria at 12 or 24 weeks 6.IBS severity at 12 weeks by donors (one donor giving FMT to several patients) 7.IBS severity at 12 weeks and at 24 weeks by IBS subtypes according to transit pattern IBS severity 8.IBS Quality of life at 12 weeks and 24 weeks 9.Patient’s perception of FMT 10. Secondary effects of FMT. ;Primary end point(s): Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS.;Timepoint(s) of evaluation of this end point: 12 semaines après FMT

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Secondary

Measure	Time frame
Secondary end point(s): 1. Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 50 points decrease in IBS-SSS. 2. FMT success : patient’s microbiota 12 weeks after FMT closer to that of the donor than the patient’s microbiota before FMT. The composition of the patient’s fecal microbiota 12 weeks after FMT will be compared to the patient’s microbiota before transplantation and to the donor using the Sorensen similarity index. The FMT will be considered as a success if the Sorensen index [patient after FMT vs donor] > Sorensen index [patient after FMT vs patient before FMT] and if the Sorensen index [patient after FMT vs donor] = 0,6. The composition of fecal microbiota will be measured by pyrosequencing (16S RNA). 3. Intestinal microbiota composition and diversity at week 12 and 24 assessed by 16s sequencing. Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor’s microbiota. Microbiota composition will be assessed using Qiime pipeline and analyzed at all phylogenetic levels. Diversity will be evaluated using Shannon index, Simpson index, Chao1 index and number of observed species. 4. Efficacy (decrease in IBS severity >75 points) at week 24 according to FMT success. 5. EMA Endpoint at week 12 and 24 defined as a patient who fulfils the response criteria (simultaneous improvement of transit and abdominal pain) displayed in the following for at least 50% of the observation time. 6. Percentage of responders in the different subgroups IBS-D, IBS-C and IBS-M using the primary endpoint at week 12 and 24. 7. Mean IBS-SSS (IBS severity), comparison between FMT and placebo at 12 and 24 weeks) 8. Mean IBS-QoL score (IBS Quality of life) comparison between FMT and placebo at 12 and 24 weeks (Drossman et al. 2000) 9. Patient’s perception of FMT : Questionnaire for correct assessment of FMT or placebo and FMT acceptability) at V2 (FMT administration)	—

Measure

Time frame

Secondary end point(s): 1. Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 50 points decrease in IBS-SSS. 2. FMT success : patient’s microbiota 12 weeks after FMT closer to that of the donor than the patient’s microbiota before FMT. The composition of the patient’s fecal microbiota 12 weeks after FMT will be compared to the patient’s microbiota before transplantation and to the donor using the Sorensen similarity index. The FMT will be considered as a success if the Sorensen index [patient after FMT vs donor] > Sorensen index [patient after FMT vs patient before FMT] and if the Sorensen index [patient after FMT vs donor] = 0,6. The composition of fecal microbiota will be measured by pyrosequencing (16S RNA). 3. Intestinal microbiota composition and diversity at week 12 and 24 assessed by 16s sequencing. Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor’s microbiota. Microbiota composition will be assessed using Qiime pipeline and analyzed at all phylogenetic levels. Diversity will be evaluated using Shannon index, Simpson index, Chao1 index and number of observed species. 4. Efficacy (decrease in IBS severity >75 points) at week 24 according to FMT success. 5. EMA Endpoint at week 12 and 24 defined as a patient who fulfils the response criteria (simultaneous improvement of transit and abdominal pain) displayed in the following for at least 50% of the observation time. 6. Percentage of responders in the different subgroups IBS-D, IBS-C and IBS-M using the primary endpoint at week 12 and 24. 7. Mean IBS-SSS (IBS severity), comparison between FMT and placebo at 12 and 24 weeks) 8. Mean IBS-QoL score (IBS Quality of life) comparison between FMT and placebo at 12 and 24 weeks (Drossman et al. 2000) 9. Patient’s perception of FMT : Questionnaire for correct assessment of FMT or placebo and FMT acceptability) at V2 (FMT administration)

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Countries

France

Contacts

Public ContactDRCI - Hôpital Saint-Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

sabrina.williams@aphp.fr33144841726

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026