Impact of Fecal Microbiota Transplantation in Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT03483246
• Date of registration: 26/02/2018
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Impact of Fecal Microbiota Transplantation in Ulcerative Colitis REBALANCE-UC
• Scientific title: Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial
• Date of first enrolment: September 17, 2018
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03483246
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Harry SOKOL, PU-PH
• Affiliation: Assistance Publique - Hôpitaux de Paris

• Name: Harry SOKOL, PU-PH

• Name: Harry SOKOL, PU-PH

Key inclusion & exclusion criteria

Inclusion Criteria:

Inclusion Criteria for patients :

- Age = 18 years and < 75 years

- Ulcerative colitis (according to the Lennard Jones criteria) diagnosed for at least 3
months and :

- Currently active (PMC > 1) and planned to be treated by systemic corticosteroids
(minimum 40mg prednisone equivalent daily) Or

- Currently treated by systemic corticosteroid (minimum 40 mg prednisone equivalent
daily) within max 3 weeks Or

- Steroid dependent patients (at least one unsuccessful attempt to discontinue
steroid within the last 6 months before inclusion)

- Patient with health insurance (AME excepted)

- Informed written consent

- Female of child-bearing age with an active contraception and this during at least
period of treatment until the end of active follow-up period (week 24)

Inclusion Criteria for healthy volunteers donors :

- Age = 18 years and < 50 years

- 17 kg/m² < body mass index < 30 kg/m²

- Regular bowel movement defined as at least 1 stool every other day and maximum 2
stools per day

- Subject with health insurance (AME excepted)

- Informed Written consent

Exclusion Criteria:

Exclusion Criteria for patients :

- UC complication requiring surgical treatment

- Patient treated with high dose corticosteroid more than three weeks before inclusion
(= 40 mg prednisone equivalent daily) except in case of steroid-dependence

- Contraindication to colonoscopy or anesthesia

- Pregnancy or breastfeeding during the study

- Treatment preceding the colonoscopy with:

- intravenous infliximab and/or vedolizumab and/or ustekinumab (< 6 weeks before
the planned date of the colonoscopy) and/or subcutaneous infliximab (<2 weeks
before the planned date of the colonoscopy), and /or adalimumab (<2 weeks before
the planned date of the colonoscopy) and/or golimumab and/or tofacitinib (<4
weeks before the planned date of the colonoscopy)

- immunosuppressant (thiopurine, methotrexate, tacrolimus or other classical
immunosuppressant) started or stopped < 3 months before the planned date of the
colonoscopy

- Antibiotics, antifungic or probiotics treatment < 4 weeks before the planned date
of the colonoscopy

- participation in any other interventional study

- patient under legal protection

Exclusion Criteria for healthy volunteers donors :

- For details, please see protocol.



Age minimum: 18 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Sham-transplantation Placebo

Drug: Fecal Microbiota Transplantation (FMT)

Primary Outcome(s)

Steroid-free clinical and endoscopic remission [Time Frame: 12 weeks after FMT or sham-transplantation]

Secondary Outcome(s)

Inflammatory biological parameter 2 [Time Frame: up to 24 weeks]

Steroid-free clinical remission [Time Frame: 12 weeks after FMT or sham-transplantation]

Inflammatory biological parameter 1 [Time Frame: up to 24 weeks]

Steroid-free clinical remission [Time Frame: 24 weeks after FMT or sham-transplantation]

Steroid-free endoscopic remission [Time Frame: 12 weeks after FMT or sham-transplantation]

Endoscopic lesions [Time Frame: 12 weeks after FMT or sham-transplantation]

Microbiota composition and diversity [Time Frame: 12 and 24 weeks after FMT or sham-transplantation]

Inflammatory biological parameter 3 [Time Frame: up to 24 weeks]

Proportion of adverse events in each group [Time Frame: Through study completion, up to 25 months and one week]

Steroid-free endoscopic response [Time Frame: 12 weeks after FMTor sham-transplantation]

Secondary ID(s)

P 160931J

2017-003802-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CRB-HUEP

Institut National de la Santé Et de la Recherche Médicale, France