Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis

NCT05202990 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: APHP1805722024-518044-20-00
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate whether FMT by frozen stool capsules in pediatric UC patients in remission after corticosteroid treatment, can modify their dysbiotic gut microbiota by increasing the richness of their microbiota at 6 months.

Conditions

Pediatric Ulcerative Colitis in Remission

Keywords

Ulcerative Colitis; Pediatric Onset Inflammatory Bowel Disease; Microbiota; Fecal Microbiota Transplantation; Stool capsule; Intra-rectal enemas

Outcome Measures

Primary Outcomes (1)

• Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months.

  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.

  6 months after the first Fecal Microbiota Transplantation (FMT)

Secondary Outcomes (16)

• Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 12 months

  12 months after the first FMT

• Success of FMT by stool enema defined by an increase in the richness of the recipient's microbiota at 6 and 12 months

  6 and 12 months after the first FMT

• Success of FMT with frozen stool capsules on the change of recipient dysbiotic microbiota at 6 and 12 months

  6 and 12 months after the first FMT

• Success of FMT by enema on the change of recipient dysbiotic microbiota at 6 and 12 months

  6 and 12 months after the first FMT

• Success of FMT with frozen stool capsules on the richness and change of mucosal microbiota at 12 months

  12 months

Study Arms (2)

Fecal Microbiota Transplantation by Stool capsules

EXPERIMENTAL

Patients receiving fecal microbiota transplantation from a healthy donor in 3 times after inclusion and randomisation (Month 0 - Month 1 - Month 2) using frozen stool capsules

Drug: Fecal Microbiota Transplantation by Stool capsules

Fecal Microbiota Transplantation by enema

EXPERIMENTAL

Patients receiving fecal microbiota transplantation from a healthy donor in 3 times after inclusion and randomisation (Month 0 - Month 1 - Month 2) using frozen stool enemas.

Drug: Fecal Microbiota Transplantation by Intra-rectal enemas

Interventions

Fecal Microbiota Transplantation by Stool capsules DRUG

After colon cleansing using PolyEthylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive orally FMT (frozen stools capsules prepared from healthy donor feces).

Also known as: UC treatment

Fecal Microbiota Transplantation by Stool capsules

Fecal Microbiota Transplantation by Intra-rectal enemas DRUG

After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive first FMT (frozen preparation of stools) by infusion in caecum during colonoscopy and the second and third doses by enemas.

Also known as: UC Treatment

Fecal Microbiota Transplantation by enema

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient aged 8 to 17 years old
• 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
• Moderate active UC defined by a PUCAI score \> 35 and responding to corticosteroid treatment with a PUCAI score \<10 at enrollment
• Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months
• Patient able to swallow test capsules
• For girls of childbearing age:
• To have a negative blood (or urine) pregnancy test
• To agree to use a reliable contraceptive method from visit 1 until the end of the research
• Patient with health insurance
• Informed written consent form signed by both parents or by the person (s) with parental authority

You may not qualify if:

• isolated proctitis (\<5 cm)
• Being on enteral nutrition
• Have received antibiotic or antifungal treatment in the 4 weeks prior to enrollment
• Having a Clostridioides difficile infection in the 4 weeks prior to enrollment;
• Being pregnant or breastfeeding, or have a positive pregnancy test;
• Have a contraindication to colonoscopy or general anaesthesia

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• MRSU 938 - Research Center of Saint Antoine: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

Department of gastroenterology, Armand Trousseau Hospital

Paris, 75012, France

Location

Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital

Paris, 75015, France

Location

Department of Pediatric Gastroenterology, Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Bénédicte PIGNEUR, MD, PhD

  AP-HP - Department of Pediatric Gastroenterology Hepatology and Nutrition - Necker - Enfants Malades Hospital

  PRINCIPAL INVESTIGATOR

• Harry SOKOL, MD, PhD

  AP-HP, Department of Gastroenterology and Nutrition - Saint Antoine Hospital

  STUDY DIRECTOR

Central Study Contacts

Bénédicte PIGNEUR, MD,PhD

CONTACT

01 44 49 25 16; benedicte.pigneur@aphp.fr

Gael Plastow, PhD

CONTACT

01 44 38 18 57; gael.plastow@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)