Using capsule fecal microbiota transplantation to treat newly diagnosed chronic inflammatory diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Educational tool for melanoma patients with autoimmune diseases

  This study is testing a new educational tool to help melanoma patients with autoimmune diseases understand their treatment options better and see how easy it is for them to use.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT04751396

• Using nivolumab to treat patients with autoimmune disorders and advanced cancer

  This study is testing if nivolumab can safely help people with autoimmune disorders who also have advanced cancer by looking at how well it works and what side effects it might cause.

  Recruiting at 40 sites Phase 1 National Cancer Institute (NCI) · Birmingham, Alabama and 51 other locations · NCT03816345

• Study on how diet affects autoimmune diseases in rheumatology patients

  This study looks at how changing to a healthier diet, like the Mediterranean diet, might help people with autoimmune diseases feel better and manage their symptoms.

  Recruiting University of Central Florida · Orlando, Florida · NCT06339957

• Registry and biorepository for rheumatic diseases

  This study is collecting samples and health information from adults with rheumatic diseases at Yale clinics to help researchers learn more about these conditions and improve future treatments.

  Recruiting Yale University · New Haven, Connecticut · NCT04402086

• Understanding chronic inflammatory systemic diseases and their treatments

  This study looks at patients with chronic inflammatory diseases to see how these conditions are related and how they can be treated better.

  Recruiting Centre Hospitalier Universitaire de Besancon · Besançon · NCT04191395

• Registry for patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis receiving biologics

  This study is collecting information from patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis who are using biologic treatments to see how these medications work in real life.

  Recruiting Seoul National University Hospital · Seoul · NCT01965132

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.