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JAMA. 2017 Nov 28;318(20):1985-1993. doi: 10.1001/jama.2017.17077.

Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial.

Author information

1
Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
2
Division of Infectious Diseases, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
3
Division of Gastroenterology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
4
Division of Gastroenterology, Department of Medicine, University of Victoria, Victoria, British Columbia, Canada.
5
University of Alberta, Edmonton, Alberta, Canada.
6
Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
7
Department of Biostatistics, Indiana University, Indianapolis.
8
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
9
Department of Biological Sciences, University of Alberta, Edmonton, Alberta, Canada.
10
BGI-Shenzhen, Shenzhen, China.

Abstract

Importance:

Fecal microbiota transplantation (FMT) is effective in preventing recurrent Clostridium difficile infection (RCDI). However, it is not known whether clinical efficacy differs by route of delivery.

Objective:

To determine whether FMT by oral capsule is noninferior to colonoscopy delivery in efficacy.

Design, Setting, and Participants:

Noninferiority, unblinded, randomized trial conducted in 3 academic centers in Alberta, Canada. A total of 116 adult patients with RCDI were enrolled between October 2014 and September 2016, with follow-up to December 2016. The noninferiority margin was 15%.

Interventions:

Participants were randomly assigned to FMT by capsule or by colonoscopy at a 1:1 ratio.

Main Outcomes and Measures:

The primary outcome was the proportion of patients without RCDI 12 weeks after FMT. Secondary outcomes included (1) serious and minor adverse events, (2) changes in quality of life by the 36-Item Short Form Survey on a scale of 0 (worst possible quality of life) to 100 (best quality of life), and (3) patient perception on a scale of 1 (not at all unpleasant) to 10 (extremely unpleasant) and satisfaction on a scale of 1 (best) to 10 (worst).

Results:

Among 116 patients randomized (mean [SD] age, 58 [19] years; 79 women [68%]), 105 (91%) completed the trial, with 57 patients randomized to the capsule group and 59 to the colonoscopy group. In per-protocol analysis, prevention of RCDI after a single treatment was achieved in 96.2% in both the capsule group (51/53) and the colonoscopy group (50/52) (difference, 0%; 1-sided 95% CI, -6.1% to infinity; P < .001), meeting the criterion for noninferiority. One patient in each group died of underlying cardiopulmonary illness unrelated to FMT. Rates of minor adverse events were 5.4% for the capsule group vs 12.5% for the colonoscopy group. There was no significant between-group difference in improvement in quality of life. A significantly greater proportion of participants receiving capsules rated their experience as "not at all unpleasant" (66% vs 44%; difference, 22% [95% CI, 3%-40%]; P = .01).

Conclusions and Relevance:

Among adults with RCDI, FMT via oral capsules was not inferior to delivery by colonoscopy for preventing recurrent infection over 12 weeks. Treatment with oral capsules may be an effective approach to treating RCDI.

Trial Registration:

clinicaltrials.gov Identifier: NCT02254811.

PMID:
29183074
PMCID:
PMC5820695
DOI:
10.1001/jama.2017.17077
[Indexed for MEDLINE]
Free PMC Article

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