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Fecal microbiota transplantation for primary sclerosing cholangitis - randomized study versus sham transplantation (FMT-SCLER).
EU CTIS ID: 2023-505469-95-00
What this study is testing
To assess in patients with PSC the efficacy of FMT versus sham transplantation on ALP and bilirubin at week 48 (surrogate markers of transplantation-free survival in PSC patients) in addition to standard UDCA therapy.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females
- Subject affiliated to the French Social Security System
- 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)
You likely can't join if
- Small duct PSC
- 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.
See the full eligibility criteria
Who can join
- Males or females
- Subject affiliated to the French Social Security System
- 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 ≤50mol/l (with concomitant elevated direct bilirubin).
- 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. 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
What rules you out
- Small duct PSC
- 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
- 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
- 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.
- Inclusion in another clinical trial on medicinal products, clinical investigation protocol concerning a medical device or interventional protocol not concerning a health product, or in the exclusion period any other interventional study
- Pregnancy or desire for pregnancy or breastfeeding
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.