Primary Sclerosing Cholangitis (PSC)Phase 2FMT-SCLERNCT07477782
Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation
A Phase 2 study testing Fecal microbiota transplantation (FMT) in people with Primary Sclerosing Cholangitis (PSC) and Inflammatory Bowel Disease (IBD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC), Inflammatory Bowel Disease (IBD)
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to May 2030
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females
- Age ≥18 and ≤75 years
- Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC
- IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs)
- IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment)
- ALP ≥ 1.3 ULN (at least 2 times within a 3 months pre-inclusion period) or elevated total bilirubin ≤50 umol/l (with concomitant elevated direct bilirubin).
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- Treatment with UDCA (13-23 mg/kg/d) for at least 6 months and at the same dosage for at least 3 months
- Using contraceptive in women of childbearing potential and agrees to pursue it from inclusion until week 48. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly.
- Written informed consent signed
- Subject affiliated to the French
- Social Security System
Who cannot join
- Small duct PSC
- Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT > 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG > 1.5 ULN
- Secondary sclerosing cholangitis (notably IgG4-associated cholangitis)
- Cirrhosis defined by Liver elastometry >14.4 kPa or by current or past decompensation of cirrhosis
- AST or ALT > 7 ULN in the last 3 months
- Platelets count in the last 3 months < 100 000/mm3
Show all 34Show fewer
- Albumin in the last 3 months <35g/L
- Prothrombin index in the last 3 months < 70%
- Hepatic comorbidity: HBV infection (defined by positive Ag HBS), HCV infection (defined by positive HCV RNA), alcohol abuse (defined by alcohol intake > 30g/day), metabolic dysfunction associated steatohepatitis, primary biliary cholangitis, Hemochromatosis, Wilson disease, α1-antitrypsin deficiency, celiac disease
- History of acute cholangitis in the last 3 months prior to inclusion or current acute cholangitis
- HIV infection
- Prior liver transplantation
- Endoscopic treatment for bile duct stenosis ≤ 3 months prior to inclusion or planned within 3 months post randomization date
- History of or established or suspected hepatobiliary carcinoma.
- Any severe comorbidity that may reduce life expectancy
- History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to inclusion)
- Dosage changes of treatment for liver disease in the last 3 months or new treatment for liver disease started in the last 3 months
- History of colorectal carcinoma or high-grade dypsplasia in previous screening colonoscopy
- History of total colectomy
- Current active IBD defined by a partial Mayo score > 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn's Disease Activity Index (CDAI) > 150 in patients with Crohn's disease
- Changes in IBD treatment or initiation of a new treatment for IBD in the last 3 months
- Current treatment with biologics (anti-TNF agent, vedolizumab, ustekinumab) or JAK inhibitors (tofacitinnib) or prednisone > 10 mg/day or budesonide > 3 mg /day) (or treatment initiated less than one month)
- Any contra-indication to swallow capsules
- Renal insufficiency (clearance<60 ml/min)
- Unable to consent, subject to legal or administrative decision (protection measure or deprivation of liberty) or involuntary psychiatric care.
- Participation in another interventional research without prior consultation with the investigator responsible for the patient's monitoring in the present study (participation in other non-interventional studies is permitted)
- Pregnancy or desire for pregnancy or breastfeeding
- Randomization criteria
- No pregnancy (or desire for in the next year)
- No other hepatic pathology: HBV (positive HBs Ag), HCV (positive HCV antibody and positive PCR), autoimmune hepatitis
- No HIV infection (positive serology HIV1+2 antibodies)
- No documented Clostridium difficile infection at inclusion or < 10 days preceding randomization (in case of infection discovered at inclusion)
- No treatment with antibiotics, antifungics or probiotics < 4 weeks.
- Available FMT with EBV and CMV compatibility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hepatology Department, Saint Antoine Hospital
Paris, 75012
Sara LEMOINNE, MD, PhD, PU-PH, +33 1 49 28 28 36 ext. +33, sara.lemoinne@aphp.fr
About this study
Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.
Read the detailed description
Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) and characterized by progressive obliterative fibrosis of the biliary tree. PSC can lead to cirrhosis, end-stage liver disease, and hepatobiliary and colorectal cancer. Serum levels of alkaline phosphatase (ALP) and bilirubin are markers of cholestasis and have a prognostic value in PSC.
Liver transplantation is the only validated treatment since no medication has been reported to improve survival of PSC patients. However, ursodeoxycholic acid (UDCA), which has shown efficacy to improve liver tests, notably ALP, is approved for treatment of PSC and is prescribed in all PSC patients in France. Several studies have demonstrated that the gut microbiota plays an important role in the pathogenesis and the progression of PSC. First, PSC patients display an intestinal dysbiosis, regardless of IBD status. This dysbiosis is characterized by a decrease in diversity and some changes in the composition of gut microbiota. Second, fecal microbiota transplantation (FMT) from PSC patients into mice aggravate the cholestatic liver disease, suggesting an impact of the gut microbiota on PSC. Third, modulation of gut microbiota by antibiotic therapy can improve liver tests in PSC patients. A recent uncontrolled study, performed in 10 PSC patients, showed that FMT was safe. Moreover, in this study, a single FMT was associated with a reduction of ALP levels in 33% patients. FMT also increased bacterial diversity in all patients, and abundance of engrafted bacteria in patients post-FMT tended to be correlated with decreased ALP levels. Thus, FMT could be a useful therapy in PSC patients. The aim of the present trial is to assess the efficacy of FMT on ALP and bilirubin compared to sham transplantation in addition to UDCA treatment in PSC patients.
- Being tested
- Fecal microbiota transplantation (FMT), Sham-transplantation (placebo)
- Keywords
- Primary Sclerosing Cholangitis, inflammatory bowel disease, fecal microbiota transplantation, ursodeoxycholic acid, alkaline phosphatase, bilirubin
- Medical subject headings
- Cholangitis, Sclerosing, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Drug
One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy.
The patient will then receive either FMT (suspension of 50g of stools in 300ml of cryopreservative solution) in the terminal ileum or the caecum.
At W12 and W24 after first colonoscopy , the patient will receive orally 20 FMT (capsules swallowed in front of a physician or a nurse in hospital)
Sham-transplantation (placebo)Drug
One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy.
The patient will then receive sham transplantation (FMT vehicle, i.e. 300ml of cryopreservative solution) in the terminal ileum or the caecum.
At W12 and W24 after first colonoscopy , the patient will receive orally 20 sham capsules (capsules swallowed in front of a physician or a nurse in hospital)
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota | Experimental | FMT with stools from healthy donors 3 sessions of FMT in addition to standard UDCA therapy. First session of FMT: during a colonoscopy. Second and third session of FMT: 20 FMT capsules at week 12 and 24 Receives: Drug: Fecal microbiota transplantation (FMT) |
| Sham transplantation | Sham comparator | 3 sessions of sham transplantation in addition to standard UDCA therapy. First session of sham transplantation: during a colonoscopy Second and third session of sham transplantation: 20 placebo capsules at week 12 and 24. Receives: Drug: Sham-transplantation (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess in patients with PSC the efficacy of FMT versus sham transplantation on ALP and bilirubin at week 48 addition to standard UDCA therapy.
Proportion of success at week 48. Success is defined as patients with serum ALP <1.3 ULN at week 48 and a reduction of, at least 15%, compared to baseline ALP level AND normal total bilirubin ≤ 1 ULN at week 48
Measured: at week 48
Secondary outcomes (6)
Efficacy of FMT on reduction of ALP and normalization of bilirubin level at week 12, 24, 36 and 48 individually
Proportion of success at week 12, 24 , 36 and 48. Success is defined as patients with serum ALP <1.3 ULN and a reduction of, at least 15%, compared to baseline ALP level AND normal total bilirubin ≤ 1 ULN
Measured: at week 12, 24, 36 and 48
Efficacy of FMT on biochemical liver tests at week 12, 24, 36 and 48 (ALP, GGT, AST, ALT and bilirubin)
Proportion of patients that normalized all liver tests (ALP <1ULN and GGT <1 ULN and AST <1 ULN and ALT <1 ULN and total bilirubin <1 ULN) at week 12 24 36 and 48
Measured: at week 12, 24, 36 and 48
Efficacy of FMT on liver fibrosis progression
assessed by transient elastography at week 48 versus week 0
Measured: at week 48
PSC prognostic scores
PSC Prognostic scores including the MELD score, the Revised PSC Mayo Risk Score, the Amsterdam-Oxford prognostic model (week 0, week 48)
Measured: at week 0, 24 and 48
Occurrence of liver events during the study period
Percentage of patients with clinical or biological adverse events
Measured: between randomization and week 104
Occurrence of liver events during the study period
Survival rate without liver events
Measured: at week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara LEMOINNE, MD, PhD, PU-PH, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477782
- Sponsor's protocol ID
- APHP211053
- Other IDs
- 2023-505469-95-00, 2023
- Acronym
- FMT-SCLER
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation
- ClinicalTrials.gov ID
- NCT07477782
- Acronym / sponsor ID
- FMT-SCLER / APHP211053
- Keywords
- Primary Sclerosing Cholangitis, inflammatory bowel disease, fecal microbiota transplantation, ursodeoxycholic acid, alkaline phosphatase, bilirubin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 17 Mar 2026 (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.
Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.
Detailed description
Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) and characterized by progressive obliterative fibrosis of the biliary tree. PSC can lead to cirrhosis, end-stage liver disease, and hepatobiliary and colorectal cancer. Serum levels of alkaline phosphatase (ALP) and bilirubin are markers of cholestasis and have a prognostic value in PSC.
Liver transplantation is the only validated treatment since no medication has been reported to improve survival of PSC patients. However, ursodeoxycholic acid (UDCA), which has shown efficacy to improve liver tests, notably ALP, is approved for treatment of PSC and is prescribed in all PSC patients in France. Several studies have demonstrated that the gut microbiota plays an important role in the pathogenesis and the progression of PSC. First, PSC patients display an intestinal dysbiosis, regardless of IBD status. This dysbiosis is characterized by a decrease in diversity and some changes in the composition of gut microbiota. Second, fecal microbiota transplantation (FMT) from PSC patients into mice aggravate the cholestatic liver disease, suggesting an impact of the gut microbiota on PSC. Third, modulation of gut microbiota by antibiotic therapy can improve liver tests in PSC patients. A recent uncontrolled study, performed in 10 PSC patients, showed that FMT was safe. Moreover, in this study, a single FMT was associated with a reduction of ALP levels in 33% patients. FMT also increased bacterial diversity in all patients, and abundance of engrafted bacteria in patients post-FMT tended to be correlated with decreased ALP levels. Thus, FMT could be a useful therapy in PSC patients. The aim of the present trial is to assess the efficacy of FMT on ALP and bilirubin compared to sham transplantation in addition to UDCA treatment in PSC patients.
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 | Drug: Fecal microbiota transplantation (FMT)FMT with stools from healthy donors 3 sessions of FMT in addition to standard UDCA therapy. First session of FMT: during a colonoscopy. Second and third session of FMT: 20 FMT capsules at week 12 and 24 |
| Sham transplantation | Sham comparator | Drug: Sham-transplantation (placebo)3 sessions of sham transplantation in addition to standard UDCA therapy. First session of sham transplantation: during a colonoscopy Second and third session of sham transplantation: 20 placebo capsules at week 12 and 24. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females
- Age ≥18 and ≤75 years
- Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC
- IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs)
- IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment)
Key exclusion criteria (34 listed)
- Small duct PSC
- Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT > 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG > 1.5 ULN
- Secondary sclerosing cholangitis (notably IgG4-associated cholangitis)
- Cirrhosis defined by Liver elastometry >14.4 kPa or by current or past decompensation of cirrhosis
- AST or ALT > 7 ULN in the last 3 months
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 (FMT)One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy. The patient will then receive either FMT (suspension of 50g of stools in 300ml of cryopreservative solution) in the terminal ileum or the caecum. At W12 and W24 after first colonoscopy , the patient will receive orally 20 FMT (capsules swallowed in front of a physician or a nurse in hospital) | Drug | Fecal microbiota |
| Sham-transplantation (placebo)One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy. The patient will then receive sham transplantation (FMT vehicle, i.e. 300ml of cryopreservative solution) in the terminal ileum or the caecum. At W12 and W24 after first colonoscopy , the patient will receive orally 20 sham capsules (capsules swallowed in front of a physician or a nurse in hospital) | Drug | Sham transplantation |
Primary outcome
To assess in patients with PSC the efficacy of FMT versus sham transplantation on ALP and bilirubin at week 48 addition to standard UDCA therapy.
Time frame: at week 48
Proportion of success at week 48. Success is defined as patients with serum ALP <1.3 ULN at week 48 and a reduction of, at least 15%, compared to baseline ALP level AND normal total bilirubin ≤ 1 ULN at week 48
6 secondary outcomes
Efficacy of FMT on reduction of ALP and normalization of bilirubin level at week 12, 24, 36 and 48 individually
Time frame: at week 12, 24, 36 and 48
Efficacy of FMT on biochemical liver tests at week 12, 24, 36 and 48 (ALP, GGT, AST, ALT and bilirubin)
Time frame: at week 12, 24, 36 and 48
Efficacy of FMT on liver fibrosis progression
Time frame: at week 48
PSC prognostic scores
Time frame: at week 0, 24 and 48
Occurrence of liver events during the study period
Time frame: between randomization and week 104
Occurrence of liver events during the study period
Time frame: at week 48
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 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Sara LEMOINNE, MD, PhD, PU-PH principal investigator
APHP
1 site 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 (FMT) in people with Primary Sclerosing Cholangitis (PSC) and Inflammatory Bowel Disease (IBD), run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 inclusion and 34 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 Sara LEMOINNE, MD, PhD, PU-PH (+33 1 49 28 28 36 ext. +33, sara.lemoinne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess in patients with PSC the efficacy of FMT versus sham transplantation on ALP and bilirubin at week 48 addition to standard UDCA therapy. (time frame: at week 48). 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 17 Mar 2026.