Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis

Phase 2

Not yet recruiting

• Conditions: Pediatric Ulcerative Colitis in Remission
• Interventions: Drug: Fecal Microbiota Transplantation by Stool capsules; Drug: Fecal Microbiota Transplantation by Intra-rectal enemas

• Registration Number: NCT05202990
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Ulcerative colitis (UC) is characterized by chronic inflammation of the colon of undetermined origin. Their incidence is increasing dramatically in the paediatric population.

Pediatric-onset inflammatory bowel disease (IBD) is characterized by a greater severity than adult IBD. Although great progress has been made in recent years, the pathogenesis of IBD is not fully elucidated. During UC, an imbalance in the composition of gut microbiota, called "dysbiosis", has been identified. This dysbiosis is notably characterized by an increased proportion of pro-inflammatory microorganisms and a decreased proportion of anti-inflammatory microorganisms. The current treatments used in IBD mainly target the immune system through immunosuppressants, and help to shorten flairs and prevent recurrences, but there is no curative treatment.

From a therapeutic point of view, the correction of this dysbiosis is thus an attractive approach. Until now, efficacy of microbiome-based therapies such as probiotics or antibiotics has been disappointing in IBD. Fecal microbiota transplantation (FMT) consists of the administration of fecal material from a donor into the intestinal tract of a recipient to change their microbiota composition and restore healthy conditions. FMT has been successfully used for many years for the treatment of Clostridioides difficile infection. Recent studies seem to show a benefit of FMT in UC.

The investigator's main hypothesis is that the replacement of a dysbiotic microbiota by a 'healthy' microbiota by FMT can modify the richness of UC patient's microbiota and has a positive impact on the disease course.

Once steroid-induced remission will be achieved, patients will be included and randomised to receive either FMT by frozen stool capsules or enemas. They will receive 3 doses at 0, 1 and 2 months. They will be followed for one year with stool samples collected every 3 months. Clinical and laboratory data will be collected.

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation by Stool capsules	Fecal Microbiota Transplantation by Stool capsules	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
Fecal Microbiota Transplantation by enema	Fecal Microbiota Transplantation by Intra-rectal enemas	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.

Primary Outcome Measures

Name	Time	Method
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months.	6 months after the first Fecal Microbiota Transplantation (FMT)	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.

Secondary Outcome Measures

Name	Time	Method
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	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 and M12
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	The success of the FMT will be defined by a Bray Curtis (BC) Index \[recipient after FMT vs donnor\] greater than a BC Index \[recipient after FMT vs recipient before FMT\], with a BC Index \[recipient after FMT vs donnor\] ≥ 0.6.
Success of FMT with frozen stool capsules on the richness and change of mucosal microbiota at 12 months	12 months	The success of the FMT will be defined by an increase in the Shannon index of 0.5 points between the mucosal recipient microbiota at M0 and the mucosal recipient microbiota at M12
Ulcerative colitis clinical relapse	6 and 12 months	Defined as a Pediatric Ulcerative Colitis Activity Index (PUCAI) \> 35, number of relapses during the follow-up, treatments received during the follow-up
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	The success of the FMT will be defined by a Bray Curtis (BC) Index \[recipient after FMT vs donnor\] greater than a BC Index \[recipient after FMT vs recipient before FMT\], with a BC Index \[recipient after FMT vs donnor\] ≥ 0.6.
Success of FMT by enema on the change of mucosal recipient dysbiotic microbiota at 6 and 12 months	6 and 12 months after the first FMT	The success of the FMT will be defined by a Bray Curtis Index \[recipient after FMT vs donnor\] greater than a BC Index \[recipient after FMT vs recipient before FMT\], with a BC Index \[recipient after FMT vs donnor\] ≥ 0.6.
FMT with frozen stool capsules Feasibility	At inclusion, 1 and 2 months after each FMT	Number of capsules intake, facility of capsules intake, tolerance, intake duration
Change of patient's quality of life evaluated with IMPACT-3 questionnaire from inclusion until 12 months	At inclusion 2, 6, 9 and 12 months	IMPACT-3 questionnaire of 35 closed questions - scale ranging from 1 to 5 for all answers - higher score suggesting better quality of life
Change of inflammatory blood markers from baseline to 12 months	At inclusion, 6, 9 and 12 months	CRP, VS, Leucocytes levels
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	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 M12.
Success of FMT by enema on the richness and change of mucosal microbiota at 12 months	12 months	The success of the FMT will be defined by an increase in the Shannon index of 0.5 points between the mucosal recipient microbiota at M0 and the mucosal recipient microbiota at M12
Success of FMT with frozen stool capsules on the change of mucosal recipient dysbiotic microbiota at 6 and 12 months	6 and 12 months after the first FMT	The success of the FMT will be defined by a Bray Curtis (BC) Index \[recipient after FMT vs donnor\] greater than a BC Index \[recipient after FMT vs recipient before FMT\], with a BC Index \[recipient after FMT vs donnor\] ≥ 0.6.
FMT by enema Feasibility	At inclusion, 1 and 2 months after each FMT	Number of enemas, tolerance , enemas duration, difficulties related to the application of enemas
Ulcerative colitis Endoscopic relapse	12 months	Defined as an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≥ 2
Change of faecal calprotectin from baseline to 12 months	At inclusion, 6, 9 and 12 months	Calprotectin level
Incidence of adverse events	26 months

Trial Locations

Locations (3)

Department of gastroenterology, Armand Trousseau Hospital; 🇫🇷 Paris, France

Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital; 🇫🇷 Paris, France

Department of Pediatric Gastroenterology, Robert Debré Hospital; 🇫🇷 Paris, France