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NCT Number: NCT04924270

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

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.

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Key information

Conditions

Rheumatoid Arthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Colitis Colitis, Ulcerative Colonic Diseases Connective Tissue Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Ulcerative Colitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Odense University Hospital

Odense, Denmark

Location status: Recruiting

Location contact

Maja S Kragsnaes, MD PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 capsules will be thawed to room temperature before treatment.

Other names: capsule FMT

Placebo

Other

Placebo capsules consist of NaCl (0.9%) and glycerol added brown food colouring.

Primary outcomes

  1. Physical Component Summary score (PCS)

    Time frame: 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 outcomes

  1. Treatment failure

    Time frame: 8 weeks (+/- 1 week)

    Proportion of patients experiencing treatment failure at 8 weeks

  2. Mental Component Summary score (MCS)

    Time frame: 8 weeks (+/- 1 week)

    Change from baseline in the Mental Component Summary score (MCS) of the 36-Item Short Form Health Survey (SF-36)

  3. Physician's Global Assessment

    Time frame: 8 weeks (+/- 1 week)

    Change from baseline in the Physician's Global Assessment (0-100 mm VAS)

  4. Patient's Global Assessment

    Time frame: 8 weeks (+/- 1 week)

    Change from baseline in the Patient's Global Assessment (0-100 mm VAS)

  5. Fatigue

    Time frame: 8 weeks (+/- 1 week)

    Change from baseline in Fatigue visual analogue scales (0-100 mm VAS)

  6. C-reactive protein

    Time frame: 8 weeks (+/- 1 week)

    Change from baseline in C-reactive protein

Other outcomes

  1. Other secondary endpoints, specific for each disease

    Time frame: 8 weeks (+/- 1 week)

    Disease specific outcomes, not mentioned above

  2. Tertiary (secondary exploratory) endpoints

    Time frame: 52 weeks (+/- 2 weeks)

    All of the above efficacy outcomes and safety outcomes assessed after 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Maja S Kragsnaes, MD PhD

CONTACT

[email protected]

Torkell Ellingsen, MD PhD

CONTACT

[email protected]

0045 6611 3333

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Official study 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

Acronym: FRONT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2021
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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