Impact of Fecal Microbiota Transplantation in Ulcerative Colitis
NCT ID: NCT03483246
Last Updated: 2026-01-15
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2018-09-17
2027-03-27
Brief Summary
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The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.
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Detailed Description
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Conventional Immunosuppressive treatment (ie azathioprine, anti-TNF (tumor necrosis factor ), vedolizumab) used in UC are expensive and associated with potentially severe complications such as infections and cancers.
UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts.
Fecal microbiota transplantation (FMT) is now recommended in guidelines for treating recurrent Clostridium difficile infection. Although the pathogenesis involved in UC is different, FMT is a potential therapeutic strategy as transferring a healthy microbiota in an UC patient could restore the appropriate host-microbiota crosstalk.
As the gut microbiota is dramatically altered by intestinal inflammation, transferring a massive amount of microbial organisms in an inflamed gut with epithelial barrier disruption might be a suboptimal strategy and could even have detrimental effects by allowing bacterial translocation.
Thus, it's possible that performing FMT in UC patients who achieved remission after conventional treatment might be associated with better clinical outcome than in patients with active disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group B - fecal microbiota transplantation
Patients receiving the fecal microbiota transplantation (FMT) in 3 times after inclusion and randomisation
Fecal Microbiota Transplantation (FMT)
The colonoscopy for FMT will be planned as soon as possible and never more than 5 weeks after inclusion visit.
After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.
The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of physio, see donor section for details) or sham transplantation (FMT vehicle) in the cecum.
Group A- Sham-transplantation
Patients receiving the sham-transplantation in 3 times after inclusion and randomisation
Sham-transplantation Placebo
The sham-transplantation will be planned as soon as possible and never more than 5 weeks after inclusion visit.
After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.
The patient will then sham transplantation (FMT vehicle) in the cecum.
Interventions
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Fecal Microbiota Transplantation (FMT)
The colonoscopy for FMT will be planned as soon as possible and never more than 5 weeks after inclusion visit.
After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.
The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of physio, see donor section for details) or sham transplantation (FMT vehicle) in the cecum.
Sham-transplantation Placebo
The sham-transplantation will be planned as soon as possible and never more than 5 weeks after inclusion visit.
After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.
The patient will then sham transplantation (FMT vehicle) in the cecum.
Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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
\- For details, please see protocol.
18 Years
74 Years
ALL
Yes
Sponsors
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CRB-HUEP
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Harry SOKOL, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Service de Gastroentérologie et Nutrition Hôpital Saint Antoine
Paris, Paris, France
Countries
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References
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Other Identifiers
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2017-003802-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P 160931J
Identifier Type: -
Identifier Source: org_study_id
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