Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis

NCT ID: NCT05202990

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-10-01

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.

Conditions

Pediatric Ulcerative Colitis in Remission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation by Stool capsules

Intervention Type: 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).

Fecal Microbiota Transplantation by enema

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.

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation by Intra-rectal enemas

Intervention Type: 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.

Interventions

Fecal Microbiota Transplantation by Stool capsules

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).

Intervention Type: DRUG

Fecal Microbiota Transplantation by Intra-rectal enemas

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.

Intervention Type: DRUG

Other Intervention Names

UC treatment; UC Treatment

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MRSU 938 - Research Center of Saint Antoine

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bénédicte PIGNEUR, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Harry SOKOL, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Countries

France

Central Contacts

Bénédicte PIGNEUR, MD,PhD

Role: CONTACT

benedicte.pigneur@aphp.fr

01 44 49 25 16 ext. +33

Gael Plastow, PhD

Role: CONTACT

gael.plastow@aphp.fr

01 44 38 18 57 ext. +33

Facility Contacts

Julie LEMALE, MD

Role: primary

julie.lemale@aphp.fr

01 44 73 64 46 ext. +33

Bénédicte PIGNEUR

Role: primary

benedicte.pigneur@aphp.fr

01 44 49 25 16 ext. +33

Alexis MOSCA, MD, PhD

Role: primary

alexis.mosca@aphp.fr

01 40 03 57 12 ext. +33

Other Identifiers

2024-518044-20-00

Identifier Type: CTIS

Identifier Source: secondary_id

APHP180572

Identifier Type: -

Identifier Source: org_study_id