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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000311-71-FR

Enrollment

Registered

2021-09-17

Start date

2022-02-11

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Interventions

Product Name: Microbiote fécal Pharmaceutical Form: Capsule

Eligibility

Sex/Gender

All

Inclusion criteria

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 ( 35 and responding to treatment with corticosteroids at 40 mg / day maximum with, on inclusion, a PUCAI score =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Criteria for non-inclusion of the TMF Receiver: - Have isolated proctitis ( 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) + Exclusion criteria: According to ANSM criteria See below.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether TMF by frozen stool capsules in pediatric patients with UC, in remission after treatment with corticosteroids, makes it possible to modify their dysbiotic microbiota by increasing the richness of their microbiota at 6 months. ;Secondary Objective: Avaluate 1.TMF by capsules increases the richness of their microbiota at 12 months 2. TMF by enemas increases the richness of their microbiota at 6 months and 12 months. 3. TMF by capsules makes it possible to modify their dysbiotic microbiota by making it closer to that of healthy donors in the long term (at 6 and 12 months). 4. TMF by enemas can modify their dysbiotic microbiota by making it closer to that of healthy donors in the long term (at 6 and 12 months). 5.TMF by capsules or enemas changes their microbiota bound to the mucosa at 12 months. To assess 6. the feasibility of TMF by capsules and by long-term enema. 7. the efficacy of TMF by capsules and by enema on clinical relapse at 6 and 12 months. 8. the effectiveness of TMF by capsules and by enema on endoscopic relapse at 12 months. 9. the effect of capsule and enema TMF on markers of inflammation, and fecal biomarkers such as fecal calprotectin. 10. and 11. (see protocol);Primary end point(s): Success of TMF by frozen stool capsules, defined by an increase in the richness of the recipient's microbiota at 6 months. This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in the Shannon Index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M6. ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To assess whether TMF by frozen stool capsules in pediatric patients with UC, in remission after treatment with corticosteroids, makes it possible to modify their dysbiotic microbiota by increasing the richness of their microbiota at 6 months. ;Secondary Objective: Avaluate 1.TMF by capsules increases the richness of their microbiota at 12 months 2. TMF by enemas increases the richness of their microbiota at 6 months and 12 months. 3. TMF by capsules makes it possible to modify their dysbiotic microbiota by making it closer to that of healthy donors in the long term (at 6 and 12 months). 4. TMF by enemas can modify their dysbiotic microbiota by making it closer to that of healthy donors in the long term (at 6 and 12 months). 5.TMF by capsules or enemas changes their microbiota bound to the mucosa at 12 months. To assess 6. the feasibility of TMF by capsules and by long-term enema. 7. the efficacy of TMF by capsules and by enema on clinical relapse at 6 and 12 months. 8. the effectiveness of TMF by capsules and by enema on endoscopic relapse at 12 months. 9. the effect of capsule and enema TMF on markers of inflammation, and fecal biomarkers such as fecal calprotectin. 10. and 11. (see protocol);Primary end point(s): Success of TMF by frozen stool capsules, defined by an increase in the richness of the recipient's microbiota at 6 months. This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in the Shannon Index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M6. ;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. The success of TMF by frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 12 months. This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in the Shannon Index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M12. 2. The success of TMF by enemas defined by an increase in the richness of the recipient's microbiota at 6 and 12 months. This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in Shannon's index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M6 and M12. 3. The success of TMF by capsules at 6 and 12 months defined by a microbiota of the recipient closer to that of the healthy donor than that of the recipient before the TMF, evaluated by the Bray-Curtis index (BC). Success will therefore be defined by an index of BC [recipient after TMF vs. donor] higher than the BC index [recipient after TMF vs. recipient before TMF]), with an index of BC [recipient after TMF vs. donor] = 0.6. 4. The success of TMF by enemas at 6 and 12 months defined by a microbiota of the recipient after TMF closer to that of the healthy donor than to that of the recipient before TMF. Success will be defined by an index of BC [recipient after TMF vs. donor]> BC index [recipient after TMF vs. recipient before TMF] with an index of BC [recipient after TMF vs. donor] = 0.6. 5. The modification of the microbiota associated with the mucosa at 0 and 12 months. The microbiota associated with the mucosa will be studied on the biopsies collected during colonoscopies at M0 and M12, and the microbiota will be analyzed by the MISeq technique (16S RNA). The same success criteria will be analyzed as for the faecal microbiota at M0 and M12 (using the Shannon index and t	—

Measure

Time frame

Secondary end point(s): 1. The success of TMF by frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 12 months. This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in the Shannon Index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M12. 2. The success of TMF by enemas defined by an increase in the richness of the recipient's microbiota at 6 and 12 months. This will be evaluated by measuring the alpha diversity of the microbiota using the Shannon index. The success of TMF will be defined by an increase in Shannon's index of 0.5 points between the recipient's microbiota at M0 and the recipient's microbiota at M6 and M12. 3. The success of TMF by capsules at 6 and 12 months defined by a microbiota of the recipient closer to that of the healthy donor than that of the recipient before the TMF, evaluated by the Bray-Curtis index (BC). Success will therefore be defined by an index of BC [recipient after TMF vs. donor] higher than the BC index [recipient after TMF vs. recipient before TMF]), with an index of BC [recipient after TMF vs. donor] = 0.6. 4. The success of TMF by enemas at 6 and 12 months defined by a microbiota of the recipient after TMF closer to that of the healthy donor than to that of the recipient before TMF. Success will be defined by an index of BC [recipient after TMF vs. donor]> BC index [recipient after TMF vs. recipient before TMF] with an index of BC [recipient after TMF vs. donor] = 0.6. 5. The modification of the microbiota associated with the mucosa at 0 and 12 months. The microbiota associated with the mucosa will be studied on the biopsies collected during colonoscopies at M0 and M12, and the microbiota will be analyzed by the MISeq technique (16S RNA). The same success criteria will be analyzed as for the faecal microbiota at M0 and M12 (using the Shannon index and t

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Countries

France

Contacts

Public ContactProject Manager

AP-HP /DRCI

aurelie.guimfack@aphp.fr+33144 84 17 98

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026