Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis

Launched by UNIVERSITY OF AARHUS · Mar 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a treatment called faecal microbiota transplantation (FMT) to help patients with systemic sclerosis who are experiencing chronic diarrhea. Chronic diarrhea means having loose or watery stools three or more times a day for at least half of the days in the past month. The goal is to see if FMT can safely improve these symptoms in patients diagnosed with systemic sclerosis, a condition that affects the skin and internal organs.

To participate in this trial, individuals must be over 18 years old and have a confirmed diagnosis of systemic sclerosis. However, some people will not be able to join, such as those who are pregnant, have certain serious health conditions, or have had specific recent treatments that could interfere with the study. This trial is not yet recruiting participants, but once it begins, eligible participants can expect to learn more about FMT and how it might help their condition. It’s important to note that the trial has strict guidelines to ensure the safety of everyone involved.

Gender

ALL

Eligibility criteria

• 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