Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

19 Jan 2026 → ongoing

Decision date (initial)

2024-09-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-517078-52-00

EudraCT number

2017-004967-11

ClinicalTrials.gov

NCT03524352

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the relapse delay after fecal microbiota transplantation versus sham transplatation for recurrent pouchitis in IPAA for ulcerative colitis.

Secondary objectives 6

1. Efficacy of fecal microbiota transplantation on the relapse rate at week 24
2. Efficacy of fecal microbiota transplantation on the relapse rate at week 52
3. Instauration of alternative treatment within week 52
4. Safety of fecal microbiota transplantation in cas of pouchitis
5. Modification of the fecal microbiota of a patient with ileal pouch for ulcerative colitis complicated of recurrent pouchitis, in remission after antibiotherapy after fecal transplant microbiota from a healthy donor at week 8
6. Evolution of health-related to disability

Conditions and MedDRA coding

Patients operated with an IPAA for ulcerative colitis woth active recurrent pouchitis.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
2. Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure
3. Willing and able to adhere to the study visit scheduled and other protocol requirements
4. Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
5. Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation).
6. Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
7. Subject must affiliation with social security system or beneficiary from such system
8. Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception

Exclusion criteria 15

1. Crohn disease or indeterminate colitis
2. Anastomotic stenosis
3. Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
4. Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
5. Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit
6. Prior treatment with a biologic within 3 month prior the transplantation visit
7. Documented active infection of any kind in the last 6 months likely to require anti- infective treatment during the next months
8. Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)
9. Infection with chronic HIV
10. Pregnant female or breastfeeding
11. Chronic medical or psychiatric disease that may interfere with subject’s ability to comply with study procedures
12. Administration of investigational drug within 3 months prior to planned FMT
13. Adults under guardianship, Safeguard justice or trusteeship
14. Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
15. Patients with contraindication to colonoscopy or anesthesia (if necessary)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Delay between the date of transplantation and the date of the Clinical and endoscopic relapse defined by a Pouchitis Disease Activity Index (Appendix) ≥ 7 points.

Secondary endpoints 6

1. Relapse at week 24 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 24
2. Relapse at week 52 defined as a Pouchitis Disease Activity Index (PDAI) superior or equal to 7 at week 52
3. Delay within the transplantation and the instauration of an antibiotherapy or alternative treatment (immunosuppressive and/or biotherapy and/or corticotherapy)
4. Registered of adverse events defined by Common Terminology Criteria for Adverse Events (4.3) during 104 weeks post-transplantation according to ANSM recommendation.
5. Fecal microbiota engraftment at 8 weeks defined by : Sorensen’s index [receiver 8 weeks after FMT vs donor] > Sorensen’s index [receiver 8 weeks after FMT vs receiver before FMT]) with Sorensen’s index [receiver 8 weeks after FMT vs donor] = 0.6. To assess this endpoint, fecal microbiota composition will be analyzed for donor sample, receiver sample before FMT and 8 weeks after FMT, using 16S sequencing (Illumina Miseq technology)
6. IBD Disability Index at weeks -2, baseline, 8, 24, 52 and unscheduled visit

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette, Cs 69301 Cs 69301

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Soizic Boinet

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Soizic Boinet

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications