Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

Phase 2

Recruiting

• Conditions: Psoriatic Arthritis; Ankylosing Spondylitis; Rheumatoid Arthritis; Crohn Disease; Ulcerative Colitis; Pulmonary Sarcoidosis
• Interventions: Biological: Faecal microbiota transplantation; Other: Placebo

• Registration Number: NCT04924270
• Lead Sponsor: Odense University Hospital

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), pulmonary sarcoidosis (PSar), 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-11
• Status Verified: 2023-12
• Study Start: 2023-12-13
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cFMT	Faecal microbiota transplantation	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Physical Component Summary score (PCS)	8 weeks (+/- 1 week)	Change from baseline in the Physical Component Summary score (PCS) of the 36-Item Short Form Health Survey (SF-36)

Secondary Outcome Measures

Name	Time	Method
Mental Component Summary score (MCS)	8 weeks (+/- 1 week)	Change from baseline in the Mental Component Summary score (MCS) of the 36-Item Short Form Health Survey (SF-36)
Treatment failure	8 weeks (+/- 1 week)	Proportion of patients experiencing treatment failure at 8 weeks
Physician's Global Assessment	8 weeks (+/- 1 week)	Change from baseline in the Physician's Global Assessment (0-100 mm VAS)
Patient's Global Assessment	8 weeks (+/- 1 week)	Change from baseline in the Patient's Global Assessment (0-100 mm VAS)
Fatigue	8 weeks (+/- 1 week)	Change from baseline in Fatigue visual analogue scales (0-100 mm VAS)
C-reactive protein	8 weeks (+/- 1 week)	Change from baseline in C-reactive protein

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark