BibTex format
@article{Al-Shakhshir:2025:10.1136/bmjopen-2024-095392,
author = {Al-Shakhshir, S and Quraishi, MN and Mullish, B and Patel, A and Vince, A and Rowe, A and Homer, V and Jackson, N and Gyimah, D and Shabir, S and Manzoor, S and Cooney, R and Alrubaiy, L and Quince, C and van, Schaik W and Hares, M and Beggs, AD and Efstathiou, E and Rimmer, P and Weston, C and Iqbal, T and Trivedi, PJ},
doi = {10.1136/bmjopen-2024-095392},
journal = {BMJ Open},
pages = {e095392--e095392},
title = {FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO): study protocol for a randomised, multicentre, phase IIa, placebo-controlled trial},
url = {http://dx.doi.org/10.1136/bmjopen-2024-095392},
volume = {15},
year = {2025}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - <jats:sec> <jats:title>Introduction</jats:title> <jats:p>Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). The strong association between gut and liver inflammation has driven several pathogenic hypotheses to which the intestinal microbiome is proposed to contribute. Pilot studies of faecal microbiota transplantation (FMT) in PSC and IBD are demonstrated to be safe and associated with increased gut bacterial diversity. However, the longevity of such changes and the impact on markers of disease activity and disease progression have not been studied. The aim of this clinical trial is to determine the effects of repeated FMT as a treatment for PSC-IBD.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and analysis</jats:title> <jats:p>FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO) is a phase IIa randomised placebo-controlled trial to assess the efficacy and safety of repeated colonic administration of FMT in patients with non-cirrhotic PSC-IBD. Fifty-eight patients will be recruited from six sites across England and randomised in a 1:1 ratio between active FMT or FMT placebo arms. FMT will be manufactured by the University of Birmingham Microbiome Treatment Centre, using stool collected from rigorously screened healthy donors. A total of 8 weekly treatments will be delivered; the first through colonoscopic administration (week 1) and the remaining seven via once-weekly enema (up to week 8). Participants will then be followed on a 12-weekly basis until week 48 from the first treatment visit. The primary efficacy outcome will be to determine the effect of FMT on serum alkaline phosphatase values over time (end of study at 48 weeks). Key secondary outcomes will be to evaluate the impact of FMT on oth
AU - Al-Shakhshir,S
AU - Quraishi,MN
AU - Mullish,B
AU - Patel,A
AU - Vince,A
AU - Rowe,A
AU - Homer,V
AU - Jackson,N
AU - Gyimah,D
AU - Shabir,S
AU - Manzoor,S
AU - Cooney,R
AU - Alrubaiy,L
AU - Quince,C
AU - van,Schaik W
AU - Hares,M
AU - Beggs,AD
AU - Efstathiou,E
AU - Rimmer,P
AU - Weston,C
AU - Iqbal,T
AU - Trivedi,PJ
DO - 10.1136/bmjopen-2024-095392
EP - 095392
PY - 2025///
SN - 2044-6055
SP - 095392
TI - FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO): study protocol for a randomised, multicentre, phase IIa, placebo-controlled trial
T2 - BMJ Open
UR - http://dx.doi.org/10.1136/bmjopen-2024-095392
UR - https://doi.org/10.1136/bmjopen-2024-095392
VL - 15
ER -