Using capsule fecal microbiota transplantation to treat newly diagnosed chronic inflammatory diseases
Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial
This study is testing if taking capsules containing healthy gut bacteria can help people recently diagnosed with chronic inflammatory diseases feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT04924270 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of capsule fecal microbiota transplantation (cFMT) in patients who have recently been diagnosed with chronic inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, pulmonary sarcoidosis, Crohn's disease, and ulcerative colitis. The study is designed as a double-blind, placebo-controlled, randomized trial involving 200 treatment-naïve patients. Participants will be monitored over a 12-month period, with primary outcomes assessed at 8 weeks using the physical component summary of the SF-36 health survey. Secondary endpoints will also be evaluated at 52 weeks to further understand the long-term effects of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who have recently been diagnosed with treatment-naïve chronic inflammatory diseases.
Not a fit: Patients who are currently undergoing biological therapy or have serious chronic infections or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients with chronic inflammatory diseases, potentially improving their quality of life and disease management.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other conditions, this specific application in newly diagnosed chronic inflammatory diseases is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Odense
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Torkell Ellingsen, MD PhD — Odense University Hospital
- Study coordinator: Torkell Ellingsen, MD PhD
- Email: torkell.ellingsen@rsyd.dk
- Phone: 0045 6611 3333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.