Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases
Phase 2 · Testing Faecal microbiota transplantation · 1 site · Odense University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Faecal microbiota transplantation (a biologic) as a possible treatment. Condition(s) listed: Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2023-12-13.
- Main results expected around 2027-03-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Denmark.
Main thing being measured
- Physical Component Summary score (PCS) (8 weeks (+/- 1 week))
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Crohn Disease; Ulcerative Colitis |
| Lead sponsor | Odense University Hospital |
| Collaborators | Region of Southern Denmark; University of Southern Denmark |
| Enrollment | 200 (estimated) |
| Start date | 2023-12-13 |
| Primary completion (est.) | 2027-03-01 |
| First posted | 2021-06-11 |
| Last updated | 2025-12-05 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT04924270 |
Interventions
- Faecal microbiota transplantation (Biological)
The capsule FMT transplant consists of faeces obtained from a thoroughly screened, unpaid, anonymous stool donor. Each FMT product is made from 50g faeces diluted in sterile saline (0.9% NaCl) and glycerol, blended, centrifuged and filtered to remove particulate material before transfer to double-layered capsules. The FMT capsules will be stored at - 80 ⁰C until use. On the day of the FMT, the FMT… - Placebo (Other)
Placebo capsules consist of NaCl (0.9%) and glycerol added brown food colouring.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital | Odense | Denmark | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.