Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
NCT ID: NCT06333795
Last Updated: 2024-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-04-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active treatment
Active capsule FMT-treatment
Faecal Microbiota Transplantation (FMT)
Treatment is given as capsules.
Placebo
Placebo capsules are given.
Placebo
Treatment is given as capsules.
Interventions
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Faecal Microbiota Transplantation (FMT)
Treatment is given as capsules.
Placebo
Treatment is given as capsules.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Klaus Krogh
MD, DMSc, PhD, Professor
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Other Identifiers
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1-10-72-131-23
Identifier Type: -
Identifier Source: org_study_id
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