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NCT06333795Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
20 (actual)
First submitted
5 Mar 2024
Start date
1 Apr 2024
Primary completion date
21 Jan 2026
Lead sponsor
University of Aarhus
NCT number
NCT06333795

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 1 Apr 2024 to the primary completion date, 21 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment with FMT
  • Treatment with antibiotics within the past 6 weeks
  • Dysregulated thyroid disease (TSH) blood sample from previous consultations maximum 6 months old from
  • Previous abdominal surgery (minor surgical procedures ex. appendectomy is allowed)

Other illness

  • 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)

Lab values

  • 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

Other

  • 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)
  • Changes in morphine treatment within the past 4 weeks
  • Known intestinal stricture
  • Planned MR scan within the study period
  • Pacemaker/ICD
  • Changes in medicine that affect the GI tract within the past four weeks.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus University Hospital
Coordinator of this site? Confirm its status
AarhusDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.