FARGO: A Randomised, Phase IIa, Multi-centre, Placebo-controlled Trial of FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• An established clinical diagnosis of large duct PSC, with compatible features as assessed by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)

• A persistent ALP value above normal (at least 2 readings at this value over 6 months before screening)

• Evidence of early to moderate stage liver fibrosis, as suspected by any of the following:

∙ Median VCTE score of ≤14.4kPa, with an interquartile range ≤30%

‣ Previous liver biopsy indicating at an absence of established cirrhosis, Ishak fibrosis stage \<IV (or equivalent) in the last 24 months

‣ Serum enhanced liver fibrosis score (ELF) ≤9.8

• A colonoscopy showing no evidence of dysplasia/neoplasia within 24 months before screening

• No evidence of active colitis, as evidenced by a Partial Mayo Score of ≤4, with a score of \<2 on the rectal bleeding domain at screening

⁃ Individuals with IBD who are receiving treatment with biologics, immunosuppression or corticosteroids must be taking a stable dose for at least twelve weeks prior to screening, and be expected to remain on the same medication/same dose for the duration of the trial

⁃ Individuals with PSC having overlapping features of autoimmune hepatitis may be included, provided:

• The dosage of immunosuppression has remained stable for at least twelve weeks prior to screening, and be expected to remain on the same medication/same dose for the duration of the trial; and

∙ There is evidence of concomitant colitis

Locations
Other Locations
United Kingdom
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
King's College Hospital, King's College Hospital NHS Foundation Trust
RECRUITING
London
Royal Free Hospital, Royal Free London NHS Foundation Trust
RECRUITING
London
St Mark's Hospital, London North West University Healthcare NHS Trust
NOT_YET_RECRUITING
London
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Contact Information
Primary
Helen Coulthard
FARGO@trials.bham.ac.uk
+44 (0121) 3718198
Backup
Anna Rowe
FARGO@trials.bham.ac.uk
+44 (0121) 3718117
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2026-07-29
Participants
Target number of participants: 58
Treatments
Active_comparator: Faecal Microbiota Transplant (FMT)
FMT 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
Placebo_comparator: FMT Placebo
FMT Placebo is 50mL aliquots of 0.9% w/v saline and glycerol in a ratio of 9 parts saline: 1 part glycerol v/v.
Sponsors
Leads: University of Birmingham
Collaborators: PSC Support, Life Arc

This content was sourced from clinicaltrials.gov

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