Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924270
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2021-06-07
Brief Title:
Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
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 Crohns Disease and Ulcerative Colitis a 52-week Double-blind Randomised Placebo-controlled Exploratory Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRONT
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 11 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 Crohns 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 patients informed consent has been obtained to ensure no unnecessary treatment delay Stratified by CID diagnosis patients will be randomised 11 to either placebo or single-donor cFMT processed from stool provided to the hospital from anonymous-to-the-patient healthy donors The experimental intervention FMTplacebo will be repeated once weekly the first month ie 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
DESIGN AND METHODS In this 11 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 Crohns 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 patients informed consent has been obtained to ensure no unnecessary treatment delay Stratified by CID diagnosis patients will be randomised 11 to either placebo or single-donor cFMT processed from stool provided to the hospital from anonymous-to-the-patient healthy donors The experimental intervention FMTplacebo will be repeated once weekly the first month ie 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None