FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Birmingham
About this trial
FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Age ≥ 18 years
Participants must be able to understand and comply with the purpose and procedures that are involved in the trial
An established diagnosis of colonic inflammatory bowel disease, with willingness to participate in an annual colonoscopic surveillance program, as per routine standard of care
Disqualifiers
Secondary causes of sclerosing cholangitis including, but not limited to, IgG4-related cholangitis, cholangiopathy due to acquired immunodeficiency syndrome, drug-induced sclerosing cholangitis, trauma, ischaemic cholangiopathy, choledocholithiasis (investigator discretion), or sclerosing cholangiopathy as a sequelae of hepatopancreatobiliary resection
Other causes of liver disease, including, but not limited to, IgG4-related disease; viral hepatitis; alcohol-related liver disease; clinically significant metabolic associated fatty liver disease (at investigator discretion); drug-induced liver disease; hereditary haemochromatosis; alpha-1-antitrypsin disease; primary biliary cholangitis; Wilson disease; Budd-Chiari Syndrome; or primary or secondary hepatopancreatobiliary cancer
The PI does not plan for any biliary intervention (endoscopic, percutaneous or surgical) for the duration of the trial OR
The investigator decides that they do not wish to perform any biliary intervention (endoscopic, percutaneous or surgical) on the dominant stenosis for clinical reasons of stability/patient choice
Trial design
Design model
Parallel
Treatments tested in this trial
Faecal Microbiota Transplant
Biological/VaccineFMT is 50mL aliquots of filtered suspension of stool (0.6g/mL). FMT for administration via colonoscopy will be made up of 150g stool in 250mL (5 aliquots). FMT for administration via enema will be made up of 30g stool in 50mL (1 aliquot) made up to 100mL by the addition of 50mL normal saline
FMT Placebo
Other interventionFMT Placebo is 50mL aliquots containing 0.9% w/v saline and glycerol in a ratio of 9 parts saline: 1 part glycerol v/v. FMT Placebo for administration via colonoscopy will be made up of 250mL (5 aliquots). FMT Placebo for administration via enema will be made up of 50mL (1 aliquot) made up to 100mL by the addition of 50mL normal saline
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Faecal Microbiota Transplant (FMT)Active comparator 1 intervention
Group B: FMT PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serum Alkaline Phosphatase (ALP)
Reduction in serum ALP values from baseline, measured at 48 weeks following the first dose of FMT or FMT Placebo.
Time frame
ALP at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48Secondary outcomes
1
Patient-reported outcome (PRO) measures
Patient-reported outcome (PRO) measure: Primary Sclerosing Cholangitis -Patient Reported Outcome (PSC-PRO) Questionnaire
Time frame
PSC-PRO at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 482
Patient-reported outcome (PRO) measures
Patient-reported outcome (PRO) measure: short-form (SF)-36 Questionnaire
Time frame
SF-36 at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 483
Patient-reported outcome (PRO) measures
Patient-reported outcome (PRO) measures: 5 dimensional itch scale (5D itch) Questionnaire
Time frame
5D-Itch at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 484
Patient-reported outcome (PRO) measures
Patient-reported outcome (PRO) measures: Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame
SIBDQ at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov