FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

PHASE2RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

March 27, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

July 29, 2026

Conditions
Primary Sclerosing CholangitisInflammatory Bowel Diseases
Interventions
BIOLOGICAL

Faecal Microbiota Transplant

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

OTHER

FMT Placebo

FMT 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

Trial Locations (5)

B15 2TH

RECRUITING

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham

NW10 7NS

NOT_YET_RECRUITING

St Mark's Hospital, London North West University Healthcare NHS Trust, London

NW3 2QG

RECRUITING

Royal Free Hospital, Royal Free London NHS Foundation Trust, London

SE5 9RS

RECRUITING

King's College Hospital, King's College Hospital NHS Foundation Trust, London

OX3 9DU

RECRUITING

John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PSC Support

UNKNOWN

collaborator

Life Arc

UNKNOWN

lead

University of Birmingham

OTHER