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Tests treatment safety and results for Rheumatoid Arthritis
Official title Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases
ClinicalTrials.gov ID: NCT04924270
What this study is testing
What is Faecal microbiota transplantation?
Faecal microbiota transplantation is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for rheumatoid arthritis.
Also referred to as capsule FMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Presence of CID treatment indication (no contra-indications) and patient accept to start first-line standard treatment in accordance with the...
- Age 18 to 75 years.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.