Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases
FRONT
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
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Dec 2023
Longer than P75 for phase_2 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
December 5, 2025
December 1, 2025
3.2 years
June 7, 2021
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Component Summary score (PCS)
Change from baseline in the Physical Component Summary score (PCS) of the 36-Item Short Form Health Survey (SF-36)
8 weeks (+/- 1 week)
Secondary Outcomes (6)
Treatment failure
8 weeks (+/- 1 week)
Mental Component Summary score (MCS)
8 weeks (+/- 1 week)
Physician's Global Assessment
8 weeks (+/- 1 week)
Patient's Global Assessment
8 weeks (+/- 1 week)
Fatigue
8 weeks (+/- 1 week)
- +1 more secondary outcomes
Other Outcomes (2)
Other secondary endpoints, specific for each disease
8 weeks (+/- 1 week)
Tertiary (secondary exploratory) endpoints
52 weeks (+/- 2 weeks)
Study Arms (2)
cFMT
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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 capsules will be thawed to room temperature before treatment.
Eligibility Criteria
You may qualify 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 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.
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Region of Southern Denmarkcollaborator
- University of Southern Denmarkcollaborator
Study Sites (1)
Odense University Hospital
Odense, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torkell Ellingsen, MD PhD
Odense University Hospital
- PRINCIPAL INVESTIGATOR
Maja S Kragsnaes, MD PhD
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD, Clinical professor and head of research
Study Record Dates
First Submitted
June 7, 2021
First Posted
June 11, 2021
Study Start
December 13, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
December 5, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Data will be available upon reasonable request. This will require review and approval by the trial scientific board and the data responsible parties. Terms of collaboration will be reached together with a signed collaboration agreement and data processor agreement.