NCT06333795

Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis

Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - a Randomized, Double-blinded, Safety and Pilot-efficacy Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.

Detailed description

The present study aims to assess the feasibility, pilot efficacy, and safety of FMT for patients with Systemic Sclerosis. Participants will undergo two interventions in this present study. In the first intervention, participants are randomized 1:1 for either active FMT or Placebo. This first intervention consists of two doses of FMT with a 3-7 day gap. In the second intervention, all participants receive 1 dose of active FMT treatment. This study design allows researchers to evaluate the safety of FMT in this patient group, and compare the effects of FMT in the FMT-treated group vs the placebo group, to see if FMT promotes remission of Chronic diarrhea. Furthermore, researchers will be able to gain insights into whether 2 initial doses are superior to one.

Conditions

• Diarrhea
• Systemic Sclerosis

Interventions

Type	Name	Description
PROCEDURE	Faecal Microbiota Transplantation (FMT)	Treatment is given as capsules.
PROCEDURE	Placebo	Treatment is given as capsules.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-01-21
• Completion: 2026-02-23
• First posted: 2024-03-27
• Last updated: 2026-03-04

Locations

1 site across 1 country: Denmark