PouchitisPhase 3POCANCT03524352
the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
A Phase 3 study testing fecal microbiota in people with Pouchitis, run by Nantes University Hospital at 13 sites in France.
Trial summary
Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pouchitis
- What is being tested?
- fecal microbiota
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 13 sitesFrance
- Study dates
- 12 Mar 2020to 12 May 2028
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
4.2. INCLUSION CRITERIA
Subjects must satisfy the following criteria to be enrolled in the study:
- Male or female ≥ 18 years at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to conduct the study related assessments/procedure.
- Willing and able to adhere to the study visit scheduled and other protocol requirements.
- Subjects must have been operated with ileal pouch anal anastomosis (IPAA) with a duration of at least 6 month prior the screening visit.
- Subject must have a diagnosis of recurrent pouchitis defined as at least 2 episodes in the last year or relapsing immediately after a reasonable response to antibiotherapy (the antifungal medication is allowed until the day before transplantation).
- Subject must be in remission with a Pouchitis Disease Activity Index (PDAI) < 7 at the screening
- Subject must affiliation with social security system or beneficiary from such system
- Female of childbearing potential must have a negative pregnancy test at screening and must agree to practice effective methods of contraception
4.3. NON-INCLUSION CRITERIA
Subjects who meet any of the following non inclusion criteria could not be enrolled in this study:
- Crohn disease or indeterminate colitis
- Anastomotic stenosis
- Subject with prior treatment by probiotic within 3 month prior to the transplantation visit
- Subject with prior treatment by corticosteroids within 6 weeks prior to the transplantation visit
- Subject with prior treatment by immunosuppressors within 3 month prior to the transplantation visit unless treatment has been introduced for more than 8 weeks at a stable dose.
- Prior treatment with a biologic within 3 month prior the transplantation visit unless treatment has been introduced for more than 8 weeks at a stable dose.
- Documented active infection of any kind in the last 6 months likely to require anti-infective treatment during the next months
- Absolute neutrophil count (ANC) < 1.5 x 109 /L (1,500 mm3)
- Infection with chronic HIV
- Pregnant female or breastfeeding
- Chronic medical or psychiatric disease that may interfere with subject's ability to comply with study procedures
- Administration of investigational drug within 3 months prior to planned FMT
- Adults under guardianship, Safeguard justice or trusteeship
- Subject with difficulty in follow-up (vacation, job transfer, geographical distance, lack of motivation).
- Patients with contraindication to colonoscopy or anesthesia (if necessary)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Angers
Angers
CHU Estaing
Clermont-Ferrand
Hopital Beaujon, Clichy
Clichy
CHU Henry Mondor
Créteil
CHU Claude Huriez
Lille
CHU Lyon Sud
Lyon
CHRU Nancy
Nancy
CHU of Nantes
Nantes
CHU de l'Archet 2
Nice
Hopital Saint Antoine
Paris
Groupe Hospitalier Sud- Hopital Haut-lévêque
Pessac
CHU Pontchaillou
Rennes
CHU Toulouse
Toulouse
About this study
Official title: Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available.
Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.
- Conditions
- Pouchitis
- Being tested
- fecal microbiota, Placebo
- Keywords
- recurrent pouchitis, fecal microbiota transplant
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiotaOther
fecal microbiota in suspension
PlaceboOther
sterile saline
| Study group | Role | What they receive |
|---|---|---|
| fecal microbiota | Experimental | Not described Receives: Other: fecal microbiota |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days between the date of transplantation and the date of relapse according to physiological and endoscopic parameter (pochitis disease activity index)
Measured: 106 weeks
Secondary outcomes (10)
Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index)
Measured: 24 weeks
Number of relapse rate according to pochitis disease activity index (physiological and endoscopic parameter)
Measured: 52 weeks
Number of days within the transplantation and the instauration of an antibiotherapy or alternative treatment
Measured: 52 weeks
Number of adverse events
Measured: 104 weeks
Number of fecal microbiota engraftment by 16S sequencing
Measured: 8 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Measured: weeks -5
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Measured: 0 week
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Measured: 8 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Measured: 24 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start12 Mar 2020
- Primary completion12 May 2028 (estimated)
- Study completion12 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PouchitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524352
- Sponsor's protocol ID
- RC17_0021
- Acronym
- POCA
- Status last verified
- Feb 2026
- First submitted
- 2 May 2018
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trang-Poisson C, Kerdreux E, Poinas A, Planche L, Sokol H, Bemer P, Cabanas K, Hivernaud E, Biron L, Flet L, Montassier E, Le Garcasson G, Chiffoleau A, Jobert A, Lepelletier D, Caillon J, Le Pape P, Imbert BM, Bourreille A. Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. Trials. 2020 Jun 3;21(1):455. doi: 10.1186/s13063-020-04330-1.
PubMed 32493442
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
- ClinicalTrials.gov ID
- NCT03524352
- Acronym / sponsor ID
- POCA / RC17_0021
- Conditions
- Pouchitis
- Keywords
- recurrent pouchitis, fecal microbiota transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 12 May 2028 (estimated)
- Study completion
- 12 May 2028 (estimated)
- First posted
- 14 May 2018 (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.
Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available.
Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fecal microbiota | Experimental | Other: fecal microbiota |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 microbiotafecal microbiota in suspension | Other | fecal microbiota |
| Placebosterile saline | Other | placebo |
Primary outcome
Number of days between the date of transplantation and the date of relapse according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 106 weeks
10 secondary outcomes
Number of relapse rate according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 24 weeks
Number of relapse rate according to pochitis disease activity index (physiological and endoscopic parameter)
Time frame: 52 weeks
Number of days within the transplantation and the instauration of an antibiotherapy or alternative treatment
Time frame: 52 weeks
Number of adverse events
Time frame: 104 weeks
Number of fecal microbiota engraftment by 16S sequencing
Time frame: 8 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: weeks -5
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 0 week
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 8 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 24 weeks
Number of evolution of health-related to disability according to physiological and endoscopic parameter (pochitis disease activity index)
Time frame: 52 weeks
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 17 Feb 2026.
- Derived from this study: PubMed 32493442Trang-Poisson C, Kerdreux E, Poinas A, Planche L, Sokol H, Bemer P, Cabanas K, Hivernaud E, Biron L, Flet L, Montassier E, Le Garcasson G, Chiffoleau A, Jobert A, Lepelletier D, Caillon J, Le Pape P, Imbert BM, Bourreille A. Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. Trials. 2020 Jun 3;21(1):455. doi: 10.1186/s13063-020-04330-1.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fecal microbiota in people with Pouchitis, run by Nantes University Hospital at 13 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?
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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days between the date of transplantation and the date of relapse according to physiological and endoscopic parameter (pochitis disease activity index) (time frame: 106 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524352, which also lists 1 linked publication.
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 17 Feb 2026.