NCT07477782

Brief 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 (UDCA) treatment in PSC patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
46mo left

Started May 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026May 2030

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

March 12, 2026

Last Update Submit

March 12, 2026

Conditions

Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)

Keywords

Primary Sclerosing Cholangitisinflammatory bowel diseasefecal microbiota transplantationursodeoxycholic acidalkaline phosphatasebilirubin

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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)

    at week 12, 24, 36 and 48

  • Efficacy of FMT on liver fibrosis progression

    at week 48

  • PSC prognostic scores

    at week 0, 24 and 48

  • Occurrence of liver events during the study period

    between randomization and week 104

  • +1 more secondary outcomes

Study Arms (2)

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

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.

Drug: Sham-transplantation (placebo)

Interventions

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)

Fecal microbiota
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)

Sham transplantation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Treatment with UDCA (13-23 mg/kg/d) for at least 6 months and at the same dosage for at least 3 months
  • Written informed consent signed
  • Subject affiliated to the French
  • Social Security System

You may not qualify if:

  • 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
  • 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
  • HIV infection
  • Prior liver transplantation
  • History of or established or suspected hepatobiliary carcinoma.
  • Any severe comorbidity that may reduce life expectancy
  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatology Department, Saint Antoine Hospital

Paris, 75012, France

Location

MeSH Terms

Conditions

Cholangitis, SclerosingInflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Sara LEMOINNE, MD, PhD, PU-PH

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara LEMOINNE, MD, PhD, PU-PH

CONTACT

+33 1 49 28 28 36sara.lemoinne@aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

May 1, 2030

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations

FR(1)