Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy

Athayde, Jonathan; Davies, Stefan M.K.; Parker, Claire E; Guizzetti, Leonardo; Ma, Christopher; Khanna, Reena; Feagan, Brian G.; Jairath, Vipul

doi:10.1007/s10620-018-5199-9

Cited by 11 publications

(11 citation statements)

References 45 publications

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“…Indeed, a recent Cochrane review concluded that only VSL#3-type probiotics were statistically superior to placebos in the prevention or treatment of pouchitis [16,26]. Given the demand for new therapies and lack of evidence for existing treatments, it is of paramount importance that trial design for pouchitis be efficient [14].…”

Section: Discussionmentioning

confidence: 99%

“…Treatment of pouchitis is largely empirical and only small placebo-controlled trials have been conducted [13,14]. Antibiotics are the main treatment for acute pouchitis, and metronidazole and ciprofloxacin are the most common initial approaches, often resulting in a rapid response, suggesting that dysbiosis is indeed involved in this pathology [2].…”

mentioning

confidence: 99%

“…There is currently very few available data concerning the efficacy of FMT in the prevention of chronic recurrent antibiotic dependent pouchitis. Moreover, only 15 randomized controlled trials have been published on pouchitis with 5 studies on chronic pouchitis, including only two on maintaining remission, both using probiotic therapies [14]. All the published studies use a variety of different designs and methods of evaluation and scores, and there is currently a need for additional high-quality trials of pouchitis treatments, and especially novel therapies.…”

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confidence: 99%

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Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Trang-Poisson

Kerdreux

Poinas

et al. 2020

Preprint

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- Background: Almost 15 % of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouch–anal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 10% of cases, inflammation of the pouch becomes chronic with very few treatments available. Previous studies have suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotics achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic-dependent pouchitis. Fecal microbiota transplantation (FMT) is a novel therapy involving the transfer of normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by the disrupted homeostasis of intestinal microbiota or dysbiosis.-Methods Our project aims to compare the delay of relapse of chronic recurrent pouchitis after FMT versus sham transplantation. Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers. The patients who respond to antibiotherapy will be randomized at a ratio of 1:1 to receive either FMT or sham transplantation.-Discussion : On April 30, 2014, WHO published an alarming report on antibiotic resistance. Finding an alternative medical treatment to antibiotics in order to prevent relapses of pouchitis is therefore becoming increasingly important given the risk posed by multiresistant bacteria. Moreover, if the results of this study are conclusive, FMT, which is less expensive than biologics, could become a routine treatment in the future.-Trial registration: The trial, published on May 14, 2018, is registered at ClinicalTrials.Gov under registration number NCT03524352: https://clinicaltrials.gov/ct2/show/NCT03524352term=NCT03524352&rank=1

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Trang-Poisson

Kerdreux

Poinas

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

“…There are currently very few available data concerning the efficacy of FMT in the prevention of chronic recurrent antibiotic-dependent pouchitis. Moreover, only 15 RCTs have been published on pouchitis with five studies on chronic pouchitis, including only two on maintaining remission, both using probiotic therapies [14]. All the published studies use a variety of different designs and methods of evaluation and scores, and there is currently a need for additional high-quality trials of pouchitis treatments, especially novel therapies.…”

Section: Introductionmentioning

confidence: 99%

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Trang-Poisson

Kerdreux

Poinas

et al. 2020

Trials

View full text Add to dashboard Cite

Background: Almost 15% of patients with ulcerative colitis (UC) will require a proctocolectomy with ileal pouchanal anastomosis (IPAA) as a result of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Around 50% will experience pouchitis, an idiopathic inflammatory condition involving the ileal reservoir, responsible for digestive symptoms, deterioration in quality of life, and disability. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 10% of cases, inflammation of the pouch becomes chronic with very few treatments available. Previous studies have suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotics achieved significant results for treating acute episodes of UC-associated pouchitis. However, there is currently no established effective treatment for chronic antibiotic-dependent pouchitis. Fecal microbiota transplantation (FMT) is a novel therapy involving the transfer of normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by the disrupted homeostasis of intestinal microbiota or dysbiosis. Methods: Our project aims to compare the delay of relapse of chronic recurrent pouchitis after FMT versus sham transplantation. Forty-two patients with active recurrent pouchitis after having undergone an IPAA for UC will be enrolled at 12 French centers. The patients who respond to antibiotherapy will be randomized at a ratio of 1:1 to receive either FMT or sham transplantation.

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A novel Monash Pouch diet in patients with an ileoanal pouch is tolerable and has favorable metabolic luminal effects

Ardalan,

Yao,

Green

et al. 2023

JGH Open

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AimsTo evaluate a whole‐food diet strategy (the Monash Pouch diet [MPD]) designed based on the interacting roles dietary factors play with pouch health. Specifically, its tolerability and acceptability, whether it achieved its dietary and metabolic goals, and the effects on symptoms and inflammation were examined.MethodsIn a 6‐week open‐label trial, patients with ileoanal pouches educated on the MPD were assessed regarding diet tolerability and acceptance, food intake (7‐day food diaries), pouch‐related symptoms (clinical pouchitis disease activity index), and, in 24‐h fecal samples, calprotectin, fermentative biomarkers, and volatile organic compounds (VOC).ResultsOf 12 patients, 6 male, mean (SD) age 55 (5) and pouch age 13 (2) years, one withdrew with partial small bowel obstruction. Tolerability was excellent in 9 (75%) and acceptance was high (81%). Targeted changes in dietary intake were achieved. Fecal branched‐ to short‐chain fatty acid ratio increased by median 60 [IQR: 11–80]% (P = 0.02). Fecal VOCs for 3 compounds were also increased, 2‐methyl‐5‐propan‐2‐ylcyclohexa‐1,3‐diene (Fold‐change [FC] 2.08), 1,3,3‐trimethyl‐2‐oxabicyclo[2.2.2]octane (FC 3.86), propan‐2‐ol (FC 2.10). All six symptomatic patients achieved symptomatic remission (P = 0.03). Fecal calprotectin at baseline was 292 [176–527] μg/g and at week 5 was 205 [148–310] μg/g (P = 0.72).ConclusionWell tolerated and accepted, the MPD achieved targeted changes in intakes and fermentation of carbohydrates relative to that of protein. There were signals of improvement in symptoms. These results indicate the need for a randomized‐controlled trial. (Trial registration: ACTRN12621000374864; https://www.anzctr.org.au/ACTRN12621000374864.aspx).

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Placebo Rates in Randomized Controlled Trials of Pouchitis Therapy

Cited by 11 publications

References 45 publications

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

A novel Monash Pouch diet in patients with an ileoanal pouch is tolerable and has favorable metabolic luminal effects

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