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JAMA. 2019 Jan 15;321(2):156-164. doi: 10.1001/jama.2018.20046.

Effect of Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial.

Author information

1
Centre for Nutrition and Gastrointestinal Disease, Adelaide Medical School, University of Adelaide and South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
2
Inflammatory Bowel Disease Service, Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
3
Inflammatory Bowel Disease Service, Department of Gastroenterology, The Queen Elizabeth Hospital, Woodville, South Australia, Australia.
4
Department of Gastroenterology, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
5
Freemasons Foundation Centre for Men's Health, Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.
6
CSIRO Health & Biosecurity, Adelaide, South Australia, Australia.

Abstract

Importance:

High-intensity, aerobically prepared fecal microbiota transplantation (FMT) has demonstrated efficacy in treating active ulcerative colitis (UC). FMT protocols involving anaerobic stool processing methods may enhance microbial viability and allow efficacy with a lower treatment intensity.

Objective:

To assess the efficacy of a short duration of FMT therapy to induce remission in UC using anaerobically prepared stool.

Design, Setting, and Participants:

A total of 73 adults with mild to moderately active UC were enrolled in a multicenter, randomized, double-blind clinical trial in 3 Australian tertiary referral centers between June 2013 and June 2016, with 12-month follow-up until June 2017.

Interventions:

Patients were randomized to receive either anaerobically prepared pooled donor FMT (n = 38) or autologous FMT (n = 35) via colonoscopy followed by 2 enemas over 7 days. Open-label therapy was offered to autologous FMT participants at 8 weeks and they were followed up for 12 months.

Main Outcomes and Measures:

The primary outcome was steroid-free remission of UC, defined as a total Mayo score of ≤2 with an endoscopic Mayo score of 1 or less at week 8. Total Mayo score ranges from 0 to 12 (0 = no disease and 12 = most severe disease). Steroid-free remission of UC was reassessed at 12 months. Secondary clinical outcomes included adverse events.

Results:

Among 73 patients who were randomized (mean age, 39 years; women, 33 [45%]), 69 (95%) completed the trial. The primary outcome was achieved in 12 of the 38 participants (32%) receiving pooled donor FMT compared with 3 of the 35 (9%) receiving autologous FMT (difference, 23% [95% CI, 4%-42%]; odds ratio, 5.0 [95% CI, 1.2-20.1]; P = .03). Five of the 12 participants (42%) who achieved the primary end point at week 8 following donor FMT maintained remission at 12 months. There were 3 serious adverse events in the donor FMT group and 2 in the autologous FMT group.

Conclusions and Relevance:

In this preliminary study of adults with mild to moderate UC, 1-week treatment with anaerobically prepared donor FMT compared with autologous FMT resulted in a higher likelihood of remission at 8 weeks. Further research is needed to assess longer-term maintenance of remission and safety.

Trial Registration:

anzctr.org.au Identifier: ACTRN12613000236796.

PMID:
30644982
PMCID:
PMC6439766
DOI:
10.1001/jama.2018.20046
[Indexed for MEDLINE]
Free PMC Article

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