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Active, not recruiting Not applicable

Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis

NCT06333795 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-04-01
Last updated
2026-03-04

Condition(s) studied

DiarrheaSystemic Sclerosis

Investigational drug(s) / intervention(s)

Faecal Microbiota Transplantation (FMT)Placebo

Faecal Microbiota Transplantation (FMT): Treatment is given as capsules.

Placebo: Treatment is given as capsules.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participants \> 18 years * Fulfilling and previously diagnosed with SSc according to the 2013 American College of Rheumatology/European League against rheumatisms SSs classification criteria\[23\] by rheumatologist or dermatologist. * Chronic diarrea is defined as loose or watery stools, three or more times a day, a minimum of 50% of the days within the last four weeks. Exclusion Criteria: * Inability to understand Danish spoken or written and/or Trial procedures. * Known or anticipated pregnancy (excluded by male sex, postmenopausal women, or otherwise negative U-HCG) * Previous treatment with FMT * Treatment with antibiotics within the past 6 weeks * Changes in morphine treatment within the past 4 weeks * Ongoing infection with Clostridioides difficile (negative PCR test) * Known serious gastrointestinal disease or GI infection (diagnosed with e.g. inflammatory bowel disease and/or gastrointestinal cancer) * Dysregulated thyroid disease (TSH) blood sample from previous consultations maximum 6 months old from * Known intestinal stricture * Planned MR scan within the study period * Pacemaker/ICD * Previous abdominal surgery (minor surgical procedures ex. appendectomy is allowed) * Changes in medicine that affect the GI tract within the past four weeks. * Known Severe end-organ disease * Lung disease with forced vital capacity(FVC)\<50% and/or diffusing lung capacity for carbon monoxide (DLCO) \<40% * Severe heart failure with ejection fraction \<30% * End-stage kidney disease with glomeration rate\<30ml/min

Primary outcome measure(s)

  • Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo). — The first week after treatment.
    Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Aarhus Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06333795 on ClinicalTrials.gov ↗ ← All trials in Denmark