Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset

Phase 1

• Conditions: ulcerative colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-000311-71-FR
• Lead Sponsor: AP-HP/DRCD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-17
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Criteria for inclusion of the patient recipient of the TMF:
- Patient aged 8 to 17;
- With UC, regardless of the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria;
- Flare-up UC defined by a PUCAI score> 35 and responding to treatment with corticosteroids at 40 mg / day maximum with, on inclusion, a PUCAI score <10;
- Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months;
- Patient capable of ingesting the test capsules;
- For girls of childbearing age:
- have a negative blood (or urine) pregnancy test;
- agree to use a reliable contraceptive method from visit 1 until the end of the research;
- Being a beneficiary of a social protection scheme or having rights (excluding AME);
- Have an informed consent form signed by both parents or by the person (s) with parental authority.

Inclusion criteria of the healthy voluntary subject donor of stool:
- Age between 18 and 50 years old (so that the donor's microbiota is in a period of stability of its flora);
- 17 kg / m² - Have a usually regular transit consisting of at least one stool every two days and a maximum of 2 stools per day;
- For women of childbearing age: have a negative pregnancy blood test;
- Being a beneficiary of a social protection scheme or having rights (excluding AME);
- Have a signed free and informed consent form.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Criteria for non-inclusion of the TMF Receiver:
- Have isolated proctitis (<5 cm)
- Have severe colitis defined by a PUCAI score> 65
- Be under enteral nutrition
- Have received an antibiotic or antifungal treatment in the 4 weeks preceding inclusion
- Have a Clostridioides difficile infection in the 4 weeks prior to inclusion
- be pregnant or breastfeeding, or have a positive pregnancy test
- Have a contraindication to colonoscopy or general anesthesia
- Participation in another intervention research involving the human person.

Criteria for non-inclusion of the healthy voluntary subject donor of stool (final and temporary) +
According to ANSM criteria
See below.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified