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Safety and Efficacy of Faecal Microbiota Transplantation in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases (FRONT)

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ClinicalTrials.gov Identifier: NCT04924270
Recruitment Status : Not yet recruiting
First Posted : June 11, 2021
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
Region of Southern Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Torkell Ellingsen, Odense University Hospital

Brief Summary:

The main purposes are to explore clinical efficacy aspects, safety, and patient acceptability associated with capsule faecal microbiota transplantation (cFMT) performed in newly diagnosed, untreated patients with chronic inflammatory rheumatic-, dermatological-, gastrointestinal- and pulmonary diseases.

In this double-blind, placebo-controlled, randomised, 52-week exploratory trial, 200 patients with 10 different diagnoses of CIDs (n = 20 in each diagnosis stratum) fulfilling the study criteria will be enrolled at time of diagnosis. The baseline visit will be performed as quickly as possible (days) after the patient's informed consent has been obtained to ensure no unnecessary treatment delay. Stratified by diagnosis, patients will be randomised (1:1) to either placebo or cFMT provided from an anonymous healthy donor. The experimental intervention cFMT/placebo will be repeated once weekly the following four weeks. In addition, all participants will be offered the Danish national guideline first-line immunosuppressive treatment following the baseline visit. At baseline, at 8 weeks (primary endpoint evaluation), and at 52 weeks a clinical examination will be conducted and clinical scores and patient-reported outcomes for each disease entity will be collected. All adverse events will be registered throughout the study.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Reactive Arthritis Ankylosing Spondylitis Psoriatic Arthritis Gouty Arthritis Psoriasis Hidradenitis Suppurativa Pulmonary Sarcoidosis Crohn Disease Ulcerative Colitis Biological: Faecal microbiota transplantation Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Clinical Efficacy Associated With Faecal Microbiota Transplantation Performed in Treatment-naïve Patients With Newly Diagnosed Rheumatoid Arthritis, Reactive Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Gouty Arthritis, Psoriasis, Hidradenitis Suppurativa, Pulmonary Sarcoidosis, Crohn's Disease, and Ulcerative Colitis: a 52-week, Double-blind, Randomised, Placebo-controlled, Exploratory Trial
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


Arm Intervention/treatment
Experimental: cFMT Biological: Faecal microbiota transplantation
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 Name: capsule FMT

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




Primary Outcome Measures :
  1. Change from baseline in the physical component score (PCS) of the 36-Item Short Form Health Survey (SF-36) [ Time Frame: 8 weeks (+/- 1 week) ]

Secondary Outcome Measures :
  1. Change from baseline in the mental component score (MCS) of the 36-Item Short Form Health Survey (SF-36) [ Time Frame: 8 weeks (+/- 1 week) ]
  2. Change from baseline in patient global assessment (VAS 0-100 mm) [ Time Frame: 8 weeks (+/- 1 week) ]
  3. Change from baseline in patient fatigue (VAS 0-100 mm) [ Time Frame: 8 weeks (+/- 1 week) ]
  4. Change from baseline in patient pain (VAS 0-100 mm) [ Time Frame: 8 weeks (+/- 1 week) ]
  5. Change from baseline in physician's global assessment (VAS 0-100 mm) [ Time Frame: 8 weeks (+/- 1 week) ]
  6. Change from baseline in C-reactive protein [ Time Frame: 8 weeks (+/- 1 week) ]
  7. Change from baseline in the physical component score (PCS) of the 36-Item Short Form Health Survey (SF-36) [ Time Frame: 52 weeks (+/- 2 weeks) ]
  8. Change from baseline in the mental component score (MCS) of the 36-Item Short Form Health Survey [ Time Frame: 52 weeks (+/- 2 weeks) ]
  9. Change from baseline in patient global assessment (VAS 0-100 mm) [ Time Frame: 52 weeks (+/- 2 weeks) ]
  10. Change from baseline in patient fatigue (VAS 0-100 mm) [ Time Frame: 52 weeks (+/- 2 weeks) ]
  11. Change from baseline in patient pain (VAS 0-100 mm) [ Time Frame: 52 weeks (+/- 2 weeks) ]
  12. Change from baseline in physician's global assessment (VAS 0-100 mm) [ Time Frame: 52 weeks (+/- 2 weeks) ]
  13. Change from baseline in C-reactive protein [ Time Frame: 52 weeks (+/- 2 weeks) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosis of rheumatoid arthritis (RA), reactive arthritis (ReA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), gouty arthritis (GA), hidradenitis suppurativa (HS), pulmonary sarcoidosis (PSar), Crohn's disease (CD), or ulcerative colitis (UC).
  • Treatment-naïve which is defined as no current or previous disease-modifying anti-rheumatic drugs or systemic immunosuppressive drugs including glucocorticoids.
  • Presence of treatment indication (no contra-indications) and patient accept to start first-line treatment in accordance with the Danish national guideline for the specific diagnosis following the baseline visit.

Exclusion Criteria:

  • Coeliac disease, food allergy or severe food intolerance.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04924270


Contacts
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Contact: Torkell Ellingsen, MD PhD 0045 6611 3333 torkell.ellingsen@rsyd.dk
Contact: Maja S. Kragsnaes, MD PhD maja.kragsnaes@dadlnet.dk

Sponsors and Collaborators
Torkell Ellingsen
Region of Southern Denmark
University of Southern Denmark
Investigators
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Principal Investigator: Torkell Ellingsen, MD PhD Odense University Hospital
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Responsible Party: Torkell Ellingsen, MD PhD, Clinical professor and head of research, Odense University Hospital
ClinicalTrials.gov Identifier: NCT04924270    
Other Study ID Numbers: 20/3106
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Torkell Ellingsen, Odense University Hospital:
Faecal microbiota transplantation
Additional relevant MeSH terms:
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Spondylitis
Hidradenitis Suppurativa
Arthritis, Reactive
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Arthritis, Gouty
Crohn Disease
Colitis
Colitis, Ulcerative
Sarcoidosis, Pulmonary
Sarcoidosis
Psoriasis
Hidradenitis
Ulcer
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases