Pediatric Ulcerative Colitis in RemissionPhase 2T-FORENCT05202990
Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis
A Phase 2 study testing Fecal Microbiota Transplantation by Stool capsules and Fecal Microbiota Transplantation by Intra-rectal enemas in people with Pediatric Ulcerative Colitis in Remission, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Ulcerative Colitis in Remission
- What is being tested?
- Fecal Microbiota Transplantation by Stool capsules and Fecal Microbiota Transplantation by Intra-rectal enemas
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jul 2026to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Department of gastroenterology, Armand Trousseau Hospital
Paris, 75012
Julie LEMALE, MD, 01 44 73 64 46 ext. +33, julie.lemale@aphp.fr
Julie LEMALE, MD
Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital
Paris, 75015
Bénédicte PIGNEUR, 01 44 49 25 16 ext. +33, benedicte.pigneur@aphp.fr
Bénédicte PIGNEUR, MD, PhD
Department of Pediatric Gastroenterology, Robert Debré Hospital
Paris, 75019
Alexis MOSCA, MD, PhD, 01 40 03 57 12 ext. +33, alexis.mosca@aphp.fr
Alexis MOSCA, MD, PhD
About this study
Official title: Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.
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.
Read the 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.
- Being tested
- Fecal Microbiota Transplantation by Stool capsules, Fecal Microbiota Transplantation by Intra-rectal enemas
- Keywords
- Ulcerative Colitis, Pediatric Onset Inflammatory Bowel Disease, Microbiota, Fecal Microbiota Transplantation, Stool capsule, Intra-rectal enemas
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation by Stool capsulesDrug
Also called UC treatment
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 enemasDrug
Also called UC Treatment
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 group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation by Stool capsules | Experimental | 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 Receives: Drug: Fecal Microbiota Transplantation by Stool capsules |
| Fecal Microbiota Transplantation by enema | Experimental | 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. Receives: Drug: Fecal Microbiota Transplantation by Intra-rectal enemas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months.
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.
Measured: 6 months after the first Fecal Microbiota Transplantation (FMT)
Secondary outcomes (16)
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 12 months
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.
Measured: 12 months after the first FMT
Success of FMT by stool enema defined by an increase in the richness of the recipient's microbiota at 6 and 12 months
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
Measured: 6 and 12 months after the first FMT
Success of FMT with frozen stool capsules on the change of recipient dysbiotic microbiota at 6 and 12 months
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.
Measured: 6 and 12 months after the first FMT
Success of FMT by enema on the change of recipient dysbiotic microbiota at 6 and 12 months
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.
Measured: 6 and 12 months after the first FMT
Success of FMT with frozen stool capsules on the richness and change of mucosal microbiota at 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
Measured: 12 months
Success of FMT by enema on the richness and change of mucosal microbiota at 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
Measured: 12 months
Success of FMT with frozen stool capsules on the change of mucosal recipient dysbiotic microbiota at 6 and 12 months
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.
Measured: 6 and 12 months after the first FMT
Success of FMT by enema on the change of mucosal recipient dysbiotic microbiota at 6 and 12 months
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.
Measured: 6 and 12 months after the first FMT
FMT with frozen stool capsules Feasibility
Number of capsules intake, facility of capsules intake, tolerance, intake duration
Measured: At inclusion, 1 and 2 months after each FMT
FMT by enema Feasibility
Number of enemas, tolerance , enemas duration, difficulties related to the application of enemas
Measured: At inclusion, 1 and 2 months after each FMT
Ulcerative colitis clinical relapse
Defined as a Pediatric Ulcerative Colitis Activity Index (PUCAI) > 35, number of relapses during the follow-up, treatments received during the follow-up
Measured: 6 and 12 months
Ulcerative colitis Endoscopic relapse
Defined as an Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≥ 2
Measured: 12 months
Change of inflammatory blood markers from baseline to 12 months
CRP, VS, Leucocytes levels
Measured: At inclusion, 6, 9 and 12 months
Change of faecal calprotectin from baseline to 12 months
Calprotectin level
Measured: At inclusion, 6, 9 and 12 months
Change of patient's quality of life evaluated with IMPACT-3 questionnaire from inclusion until 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
Measured: At inclusion 2, 6, 9 and 12 months
Incidence of adverse events
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Ulcerative Colitis in RemissionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- MRSU 938 - Research Center of Saint Antoine, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Bénédicte PIGNEUR, MD, PhD, Principal investigator, AP-HP - Department of Pediatric Gastroenterology Hepatology and Nutrition - Necker - Enfants Malades HospitalHarry SOKOL, MD, PhD, Study director, AP-HP, Department of Gastroenterology and Nutrition - Saint Antoine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202990
- Sponsor's protocol ID
- APHP180572
- Other IDs
- 2024-518044-20-00
- Acronym
- T-FORE
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT05202990
- Acronym / sponsor ID
- T-FORE / APHP180572
- Keywords
- Ulcerative Colitis, Pediatric Onset Inflammatory Bowel Disease, Microbiota, Fecal Microbiota Transplantation, Stool capsule, Intra-rectal enemas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- MRSU 938 - Research Center of Saint Antoine, URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation by Stool capsules | Experimental | Drug: Fecal Microbiota Transplantation by Stool capsulesPatients 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 | Experimental | Drug: Fecal Microbiota Transplantation by Intra-rectal enemasPatients 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplantation by Stool capsulesAlso: UC treatmentAfter 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). | Drug | Fecal Microbiota Transplantation by Stool capsules |
| Fecal Microbiota Transplantation by Intra-rectal enemasAlso: UC TreatmentAfter 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. | Drug | Fecal Microbiota Transplantation by enema |
Primary outcome
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months.
Time frame: 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.
16 secondary outcomes
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 12 months
Time frame: 12 months after the first FMT
Success of FMT by stool enema defined by an increase in the richness of the recipient's microbiota at 6 and 12 months
Time frame: 6 and 12 months after the first FMT
Success of FMT with frozen stool capsules on the change of recipient dysbiotic microbiota at 6 and 12 months
Time frame: 6 and 12 months after the first FMT
Success of FMT by enema on the change of recipient dysbiotic microbiota at 6 and 12 months
Time frame: 6 and 12 months after the first FMT
Success of FMT with frozen stool capsules on the richness and change of mucosal microbiota at 12 months
Time frame: 12 months
Success of FMT by enema on the richness and change of mucosal microbiota at 12 months
Time frame: 12 months
Success of FMT with frozen stool capsules on the change of mucosal recipient dysbiotic microbiota at 6 and 12 months
Time frame: 6 and 12 months after the first FMT
Success of FMT by enema on the change of mucosal recipient dysbiotic microbiota at 6 and 12 months
Time frame: 6 and 12 months after the first FMT
FMT with frozen stool capsules Feasibility
Time frame: At inclusion, 1 and 2 months after each FMT
FMT by enema Feasibility
Time frame: At inclusion, 1 and 2 months after each FMT
Ulcerative colitis clinical relapse
Time frame: 6 and 12 months
Ulcerative colitis Endoscopic relapse
Time frame: 12 months
Change of inflammatory blood markers from baseline to 12 months
Time frame: At inclusion, 6, 9 and 12 months
Change of faecal calprotectin from baseline to 12 months
Time frame: At inclusion, 6, 9 and 12 months
Change of patient's quality of life evaluated with IMPACT-3 questionnaire from inclusion until 12 months
Time frame: At inclusion 2, 6, 9 and 12 months
Incidence of adverse events
Time frame: 26 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bénédicte PIGNEUR, MD, PhD principal investigator
AP-HP - Department of Pediatric Gastroenterology Hepatology and Nutrition - Necker - Enfants Malades Hospital
Harry SOKOL, MD, PhD study director
AP-HP, Department of Gastroenterology and Nutrition - Saint Antoine Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplantation by Stool capsules and Fecal Microbiota Transplantation by Intra-rectal enemas in people with Pediatric Ulcerative Colitis in Remission, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte PIGNEUR, MD,PhD (01 44 49 25 16 ext. +33, benedicte.pigneur@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months. (time frame: 6 months after the first Fecal Microbiota Transplantation (FMT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.