Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis (NCT06333795) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
Denmark20 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<…
What they're measuring
1
Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo).