Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (3)

More Assistance Publique - Hôpitaux de Paris trials in France