NCT07477782 Fecal microbiota transplantation(Assistance Publique des Hôpitaux de Paris) Cholangitis, Sclerosing Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07477782 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07477782 is a hot trial to watch
Cholangitis, Sclerosing is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07477782 is notable because it evaluates Fecal microbiota transplantation(Assistance Publique des Hôpitaux de Paris) in a Phase 2 design sponsored by Assistance Publique des Hôpitaux de Paris SA. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07477782 |
| Official title | Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation (FMT-SCLER) |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Fecal microbiota transplantation(Assistance Publique des Hôpitaux de Paris) |
| Sponsor | Assistance Publique des Hôpitaux de Paris SA |
| Geography | France |
| Enrollment | 72 |
| Primary endpoint | 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. |
| Endpoint time frame | at week 48 |
| Primary completion / readout proxy | 2029-04-01 |
Protocol design and endpoint interpretation
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.
Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment. Planned enrollment of 72 participants across France shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- 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. (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
Readout outlook and evidence gap
The current protocol points to 2029-04-01 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Fecal microbiota transplantation(Assistance Publique des Hôpitaux de Paris) is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Assistance Publique des Hôpitaux de Paris SA is resolved to a normalized organization record in France. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07477782 provides a focused lens on Cholangitis, Sclerosing development. Its value will be determined by whether Fecal microbiota transplantation(Assistance Publique des Hôpitaux de Paris) can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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