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Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

RecruitingPhase 2Ages 18 Years - 75 YearsAllOdense University Hospital
NCT04924270 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

PURPOSE: The main purpose is to explore clinical efficacy and safety associated with capsule FMT (cFMT) performed in newly diagnosed, untreated patients with rheumatic and gastrointestinal chronic inflammatory diseases (CIDs). DESIGN AND METHODS: In this 1:1 double-blind, placebo-controlled, randomised, 12-month exploratory trial, 200 patients with at least one of 6 different diagnoses of CIDs fulfilling the study criteria will be enrolled at time of diagnosis. The patient groups are: rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), Crohn's disease (CD), and ulcerative colitis (UC). The primary endpoint is change from baseline to eight weeks in the physical component summary (PCS) of the short form health survey (SF-36). Key secondary clinical endpoints will be evaluated at 8 weeks. Other secondary clinical endpoints will be evaluated at 52 weeks and re

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📋 Eligibility rules (as published)
Inclusion criteria: * Newly diagnosis of treatment-naïve RA, AS, PsA, PSar, CD, or UC. * Treatment-naïve which is defined as no current or previous (within 3 months) disease-modifying anti-rheumatic drugs (DMARDs) or systemic anti-inflammatory treatment including glucocorticoids. * Presence of CID treatment indication (no contra-indications) and patient accept to start first-line standard treatment in accordance with the national guideline for the specific diagnosis following the baseline visit. * Age 18 to 75 years. Exclusion criteria: * Indication for biological therapy as primary therapy. * Celiac disease or food allergy. * Current cancer. * Hepatitis B and C, HIV, HTLV1/2, and active TB or other serious chronic infections. * Pregnant or breastfeeding women. * Not wishing to participate or not suited for FMT intervention or project evaluation.
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What it tests

  • Faecal microbiota transplantation
  • Placebo
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Where

1 site
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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