Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection

Andy · Dec 2, 2017

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.
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Paywalled at https://jamanetwork.com/journals/jama/article-abstract/2664458

Discussed here - https://www.medscape.com/viewarticle/889258?src=soc_fb_171202_mscpedt_news_mdscp_mdscp_coloncancer (You may need a Medscape account to access it)

NEW YORK (Reuters Health) - Fecal microbiota transplantation (FMT) prevents recurrent C. difficile infection whether delivered by oral capsule or by colonoscopy, according to results from a randomized noninferiority trial.

"Since the efficacy of FMT by capsules is not inferior to colonoscopy delivery, treatment of mild to moderate RCDI can become an office-based therapy,” Dr. Dina Kao from University of Alberta, Edmonton, Canada, told Reuters Health by email. “There is no obvious advantage to colonoscopy-delivered FMT, and perhaps we should move away from colonoscopy-delivered FMT in this context, unless an alternative diagnosis is suspected.”

FMT administered by colonoscopy is 90% effective for preventing recurrent C. difficile infection, but it remains unclear whether clinical efficacy differs by route of delivery.
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TiredSam · Dec 2, 2017

I'm afraid it's already been tried and failed with ME sufferers - we've been swallowing shit from the BPS brigade for decades and nobody's got better.

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Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection

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Effect of Oral Capsule– vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection

Andy Committee Member

TiredSam Committee Member

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