NCT04924270 Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases
| NCT ID | NCT04924270 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Odense University Hospital |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2023-12-13 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 reported in secondary papers. The baseline visit will be performed as quickly as possible after the patient's informed consent has been obtained to ensure no unnecessary treatment delay. Stratified by CID diagnosis, patients will be randomised (1:1) to either placebo or single-donor cFMT processed from stool provided to the hospital from anonymous-to-the-patient healthy donors. The experimental intervention FMT/placebo will be repeated once weekly the first month (i.e., each patient will receive a total of four treatments). In addition, all participants will concomitantly be offered the national guideline first-line anti-inflammatory treatment following the baseline visit. At baseline, 8 weeks, 26 weeks, and 52 weeks a thorough clinical examination will be conducted and all relevant clinical scores for each disease entity will be registered. Patient-reported-outcomes including SF-36 and disease specific questionnaires will be collected at week 1, 2, 3, 4, 8 (primary endpoint evaluation), 26 and 52. Adverse events will be monitored through out the trial.
Eligibility Criteria
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.
Contact & Investigator
Torkell Ellingsen, MD PhD
PRINCIPAL INVESTIGATOR
Odense University Hospital
Frequently Asked Questions
Who can join the NCT04924270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04924270 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04924270 currently recruiting?
Yes, NCT04924270 is actively recruiting participants. Contact the research team at torkell.ellingsen@rsyd.dk for enrollment information.
Where is the NCT04924270 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT04924270 clinical trial?
NCT04924270 is sponsored by Odense University Hospital. The principal investigator is Torkell Ellingsen, MD PhD at Odense University Hospital. The trial plans to enroll 200 participants.
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