Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases (FRONT)
Primary Purpose
Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Faecal microbiota transplantation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Faecal microbiota transplantation, Fecal microbiota transplantation
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cFMT
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Fatigue
Change from baseline in Fatigue visual analogue scales (0-100 mm VAS)
C-reactive protein
Change from baseline in C-reactive protein
Full Information
NCT ID
NCT04924270
First Posted
June 7, 2021
Last Updated
September 15, 2023
Sponsor
Torkell Ellingsen
Collaborators
Region of Southern Denmark, University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04924270
Brief Title
Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases
Acronym
FRONT
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Torkell Ellingsen
Collaborators
Region of Southern Denmark, University of Southern Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Pulmonary Sarcoidosis, Crohn Disease, Ulcerative Colitis
Keywords
Faecal microbiota transplantation, Fecal microbiota transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cFMT
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Faecal microbiota transplantation
Other Intervention Name(s)
capsule FMT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules consist of NaCl (0.9%) and glycerol added brown food colouring.
Primary Outcome Measure Information:
Title
Physical Component Summary score (PCS)
Description
Change from baseline in the Physical Component Summary score (PCS) of the 36-Item Short Form Health Survey (SF-36)
Time Frame
8 weeks (+/- 1 week)
Secondary Outcome Measure Information:
Title
Treatment failure
Description
Proportion of patients experiencing treatment failure at 8 weeks
Time Frame
8 weeks (+/- 1 week)
Title
Mental Component Summary score (MCS)
Description
Change from baseline in the Mental Component Summary score (MCS) of the 36-Item Short Form Health Survey (SF-36)
Time Frame
8 weeks (+/- 1 week)
Title
Physician's Global Assessment
Description
Change from baseline in the Physician's Global Assessment (0-100 mm VAS)
Time Frame
8 weeks (+/- 1 week)
Title
Patient's Global Assessment
Description
Change from baseline in the Patient's Global Assessment (0-100 mm VAS)
Time Frame
8 weeks (+/- 1 week)
Title
Fatigue
Description
Change from baseline in Fatigue visual analogue scales (0-100 mm VAS)
Time Frame
8 weeks (+/- 1 week)
Title
C-reactive protein
Description
Change from baseline in C-reactive protein
Time Frame
8 weeks (+/- 1 week)
Other Pre-specified Outcome Measures:
Title
Other secondary endpoints, specific for each disease
Description
Disease specific outcomes, not mentioned above
Time Frame
8 weeks (+/- 1 week)
Title
Tertiary (secondary exploratory) endpoints
Description
All of the above efficacy outcomes and safety outcomes assessed after 52 weeks
Time Frame
52 weeks (+/- 2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Torkell Ellingsen, MD PhD
Phone
0045 6611 3333
Email
torkell.ellingsen@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Maja S Kragsnaes, MD PhD
Email
maja.skov.kragsnaes@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torkell Ellingsen, MD PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maja S Kragsnaes, MD PhD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases
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