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.
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.
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.
Parallel
Faecal microbiota transplantation
Biological/VaccineThe 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.
Placebo
Other interventionPlacebo capsules consist of NaCl (0.9%) and glycerol added brown food colouring.
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)
Treatment failure
Proportion of patients experiencing treatment failure at 8 weeks
Mental Component Summary score (MCS)
Change from baseline in the Mental Component Summary score (MCS) of the 36-Item Short Form Health Survey (SF-36)
Physician's Global Assessment
Change from baseline in the Physician's Global Assessment (0-100 mm VAS)
Patient's Global Assessment
Change from baseline in the Patient's Global Assessment (0-100 mm VAS)
Other secondary endpoints, specific for each disease
Disease specific outcomes, not mentioned above
Tertiary (secondary exploratory) endpoints
All of the above efficacy outcomes and safety outcomes assessed after 52 weeks
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Odense University Hospital
Lead sponsor
Region of Southern Denmark
Collaborator
University of Southern Denmark
Collaborator
