Allogeneic faecal microbiota, pooled for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- Patient aged 8 to 17 years old"}
• {"criterion_text":"- Ulcerative colitis (UC), whatever the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria."}
• {"criterion_text":"- Moderate active UC defined by a PUCAI score > 35 and responding to corticosteroid treatment with a PUCAI score <10 at enrolment"}
• {"criterion_text":"- Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months"}
• {"criterion_text":"- Patient able to swallow test capsules"}
• {"criterion_text":"- For girls of childbearing age: \tTo have a negative blood (or urine) pregnancy test \tTo agree to use a reliable contraceptive method from visit 1 until the end of the research"}
• {"criterion_text":"- Patient with health insurance"}
• {"criterion_text":"- Informed written consent form signed by both parents or by the person (s) with parental authority"}

Exclusion criteria

• {"criterion_text":"- Isolated proctitis (<5 cm)"}
• {"criterion_text":"- Being on enteral nutrition"}
• {"criterion_text":"- Have received antibiotic or antifungal treatment in the 4 weeks prior to enrolment"}
• {"criterion_text":"- Having a Clostridioides difficile infection in the 4 weeks prior to enrolment;"}
• {"criterion_text":"- Being pregnant or breastfeeding, or have a positive pregnancy test"}
• {"criterion_text":"- Participation in other interventional research involving humans"}
• {"criterion_text":"- Have a contraindication to colonoscopy or general anaesthesia"}

Primary endpoints

• {"endpoint_text":"- Success of FMT is defined by an increase in the richness of the recipient's microbiota at 6 months. Microbiota richness will be evaluated by measuring the alpha diversity of the microbiota using Shannon index. The success of the FMT will be defined by an increase in the Shannon index of 0.5 points between the recipient microbiota at M0 and the recipient microbiota at M6.","definition_or_measurement_approach":"Microbiota richness evaluated by alpha diversity using the Shannon index; success defined as an increase of 0.5 points in Shannon index between M0 and M6."}

Secondary endpoints

• {"endpoint_text":"- Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 12 months, will be evaluated by the microbiota alpha diversity using the Shannon index. Success is defined by an increase of 0.5 points between the recipient microbiota at M0 and the recipient microbiota at M12.","definition_or_measurement_approach":"Alpha diversity (Shannon index); success = increase of 0.5 points between M0 and M12."}
• {"endpoint_text":"- Success of FMT by stool enema defined by an increase in the richness of the recipient's microbiota at 12 months will be evaluated by the microbiota alpha diversity using the Shannon index. Success is defined by an increase of 0.5 points between the recipient microbiota at M0 and the recipient microbiota at M12.","definition_or_measurement_approach":"Alpha diversity (Shannon index); success = increase of 0.5 points between M0 and M12 (applied to enema arm)."}
• {"endpoint_text":"- Success of FMT with frozen stool capsules defined by the recipient dysbiotic microbiota being more similar to the healthy donor’s microbiota at 6 and 12 months than the receiver’s before FMT. The success of the FMT is defined by a Bray Curtis (BC) Index [recipient after FMT vs donor] greater than a BC Index [recipient after FMT vs recipient before FMT], with a BC Index [recipient after FMT vs donor] ≥ 0.6","definition_or_measurement_approach":"Similarity assessed by Bray-Curtis (BC) index; success if BC[recipient after FMT vs donor] > BC[recipient after FMT vs recipient before FMT] and BC[recipient after FMT vs donor] ≥ 0.6 (assessed at 6 and 12 months)."}
• {"endpoint_text":"- Success of FMT by stool enema defined by the recipient dysbiotic microbiota being more similar to the healthy donor’s microbiota at 6 and 12 months than the receiver’s before FMT. The success of the FMT is defined by a Bray Curtis (BC) Index [recipient after FMT vs donor] greater than a BC Index [recipient after FMT vs recipient before FMT], with a BC Index [recipient after FMT vs donor] ≥ 0.6","definition_or_measurement_approach":"Similarity assessed by Bray-Curtis (BC) index; success if BC[recipient after FMT vs donor] > BC[recipient after FMT vs recipient before FMT] and BC[recipient after FMT vs donor] ≥ 0.6 (assessed at 6 and 12 months) for enema arm."}
• {"endpoint_text":"- Changes on mucosal microbiota at 0 and 12 months. Mucosal microbiota will be studied on biopsies done during colonoscopies at M0 and M12, the microbiota will be studied using the MISeq (RNA 16S). The same success criteria than faecal microbiota at M0 and M12 will be analysed (using Shannon and Bray Curtis indexes","definition_or_measurement_approach":"Mucosal microbiota from colonoscopy biopsies at M0 and M12 analyzed by MiSeq (16S rRNA); success criteria same as fecal microbiota (Shannon and Bray-Curtis indices)."}
• {"endpoint_text":"- The long term FMT feasibility with frozen stool capsules and by stool enema in children suffering from ulcerative colitis will be evaluated with the number of capsules intake, facility of capsules intake, number of enemas, FMT acceptance, enemas duration, difficulties related to the application of enemas.","definition_or_measurement_approach":"Feasibility assessed by metrics: number of capsules taken, ease of capsule intake, number of enemas received, acceptance, duration and application difficulties."}
• {"endpoint_text":"- Ulcerative colitis clinical relapse at 6 and 12 months defined as a Paediatric Ulcerative Colitis Activity Index (PUCAI) > 35, number of relapses during the follow-up, treatments received during the follow-up","definition_or_measurement_approach":"Clinical relapse defined by PUCAI > 35; record number of relapses and treatments during follow-up (assessed at 6 and 12 months)."}
• {"endpoint_text":"- Ulcerative colitis Endoscopic relapse at 12 months measured using the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) during the 12 months colonoscopy. Relapse defined as an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≥ 2","definition_or_measurement_approach":"Endoscopic relapse at 12 months measured by UCEIS; relapse defined as UCEIS ≥ 2."}
• {"endpoint_text":"- FMT effect on inflammatory blood markers measured by levels of CRP, VS, leucocytes and faecal calprotein at M0, M6, M9 and M12. Faecal calprotectin dosage will be implemented in the Coprologie Fonctionnelle laboratory of Pr Nathalie Kapel in La Pitié Salpêtrière hospital","definition_or_measurement_approach":"Inflammatory markers: CRP, ESR (VS), leukocyte count and faecal calprotectin measured at M0, M6, M9 and M12; faecal calprotectin processed at specified laboratory."}
• {"endpoint_text":"- Quality of life evolution in both treatment arms evaluated by the IMPACT-3 questionnaire (35 closed questions, Likert scale from 1 to 5 [global ranking: 35 – 175]). Higher score suggests a better quality of life","definition_or_measurement_approach":"Quality of life measured by IMPACT-3 questionnaire (score range 35–175); higher score = better QoL."}
• {"endpoint_text":"- Adverse events collection : fever, sepsis, infection, inflammatory disease relapse, … etc will be collected for the entire follow up","definition_or_measurement_approach":"Adverse events (e.g., fever, sepsis, infection, disease relapse) collected throughout follow-up."}

France

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

343

Number Of Sites

4

Number Of Participants

30

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France