742 - A Double-Blind, Randomized, Placebo-Controlled Trial of Fecal Microbiota Transplantation Capsules (FMTC) for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Aroniadis, Olga C.; Brandt, Lawrence J.; Oneto, Caterina; Feuerstadt, Paul; Sherman, Alex; Wolkoff, Allan W.; Downs, Ian; Zanetti-Yabur, Alana; Ramos, Yolanda; Cotto, Candace; Kassam, Zain; Elliott, Ryan J.; Rosenbaum, Robert; Budree, Shrish; Sadovsky, Rotem Gura; Timberlake, Sonia; Swanson, Paige; Kim, Mimi; Keller, Marla J.

doi:10.1016/s0016-5085(18)30932-6

Cited by 25 publications

(51 citation statements)

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“…Further subgroup analyses are provided in Table . Analysis according to the route of administration of the intervention demonstrated no benefit via the upper gastrointestinal tract in three pooled studies (RR = 1.35; 95% CI 0.58‐3.14), but a beneficial effect when the lower gastrointestinal tract was used when data were pooled from two studies (RR = 0.63; 95% CI 0.43‐0.93, NNT = 4; 95% CI 3‐22) . When type of control intervention used was studied, donor stool demonstrated efficacy over autologous stool in three pooled trials (RR = 0.66; 95% CI 0.50‐0.87, NNT = 3; 95% CI 3‐11) .…”

Section: Resultsmentioning

confidence: 97%

“…From these we identified 23 that appeared to be relevant to the study question. There were five articles that fulfilled the eligibility criteria, representing five separate trials containing 267 subjects (Figure ) . Overall, 92.2% of included patients had IBS‐D or IBS‐M, and 7.8% IBS‐C.…”

Section: Resultsmentioning

confidence: 99%

“…All five trials provided dichotomous data for response or non‐response to FMT . When data were pooled there were 79 (50.0%) of 158 patients assigned to FMT who failed to respond, compared with 56 (51.4%) of 109 assigned to placebo.…”

Section: Resultsmentioning

confidence: 99%

“…We performed a subgroup analysis according to method of administration of the intervention. Placebo capsules were superior to capsules containing donor stool when data were pooled from two trials, containing 100 patients, with 32 (64.0%) of 50 patients assigned to capsules containing donor stool failing to respond to therapy, compared with 16 (32.0%) of 50 allocated to placebo capsules (RR = 1.96; 95% CI 1.19 to 3.20, I 2 = 14%, P = 0.28). FMT from donor stool delivered via colonoscopy was superior to autologous stool when data were pooled from two RCTs, with 26 (39.4%) of 66 patients randomised to donor stool failing to respond to therapy, compared with 24 (64.9%) of 37 receiving autologous stool (RR = 0.63; 95% CI 0.43 to 0.93, I 2 = 0%, P = 0.71).…”

Section: Resultsmentioning

confidence: 99%

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Systematic review with meta‐analysis: efficacy of faecal microbiota transplantation for the treatment of irritable bowel syndrome

Ianiro

Eusebi

Black

et al. 2019

Aliment Pharmacol Ther

163

136

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Summary Background Increasing evidence supports the role of the gut microbiota in the aetiology of irritable bowel syndrome (IBS). Faecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridioides difficile infection in randomised controlled trials (RCTs), and may be beneficial in ulcerative colitis. However, its efficacy in IBS is uncertain. Aim To perform a systematic review and meta‐analysis to examine this issue. Methods We searched MEDLINE, EMBASE, EMBASE Classic, the Cochrane Central Register of Controlled Trials, and clinicaltrials.gov through to March 2019. RCTs recruiting adults with IBS, which compared FMT with placebo, were eligible. Dichotomous symptom data were pooled to obtain a relative risk (RR) of remaining symptomatic after therapy, with a 95% CI. Results The search strategy identified 322 citations. Five RCTs were eligible for inclusion, containing 267 patients. Overall, 92.2% of included patients had IBS‐D or IBS‐M, and only 7.8% IBS‐C. When data were pooled for all patients, irrespective of stool type, the RR of IBS symptoms not improving was 0.98 (95% CI 0.58‐1.66). Placebo capsules administered orally were superior to capsules containing donor stool in two pooled trials (RR = 1.96; 95% CI 1.19‐3.20). FMT from donor stool delivered via colonoscopy was superior to autologous stool in two pooled RCTs (RR = 0.63; 95% CI 0.43‐0.93). FMT from donor stool via nasojejunal tube showed a trend towards a benefit over autologous stool in one trial (RR = 0.69; 95% CI 0.46‐1.02). Conclusions Fresh or frozen donor stool delivered via colonoscopy or nasojejunal tube may be beneficial in IBS. Larger, more rigorously conducted trials of FMT in IBS are needed.

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Section: Resultsmentioning

confidence: 97%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Systematic review with meta‐analysis: efficacy of faecal microbiota transplantation for the treatment of irritable bowel syndrome

Ianiro

Eusebi

Black

et al. 2019

Aliment Pharmacol Ther

163

136

View full text Add to dashboard Cite

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“…However, differences were no longer significant at 12 months followup 188 . On the other hand, a separate multicenter RCT 189 comparing FMT capsules to placebo in patients with diarrhea-predominant IBS was unable to demonstrate significant symptom relief at three months with FMT, although subgroup analysis suggested patients with post-infectious IBS experienced greater improvement with FMT compared to placebo (p=0.09). The role of FMT in IBS needs to be better defined as there may be specific features in the donor microbiome as well as additional recipient characteristics that predict clinical outcomes.…”

Section: Functional Gi Disordersmentioning

confidence: 95%

The Gut Microbiome in Adult and Pediatric Functional Gastrointestinal Disorders

Shin

Preidis

Shulman

et al. 2019

Clinical Gastroenterology and Hepatology

128

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The importance of gut microbiota in gastrointestinal (GI) physiology was well described, but our ability to study gut microbial ecosystems in their entirety was limited by culture-based methods prior to the sequencing revolution. The advent of high-throughput sequencing opened new avenues, allowing us to study gut microbial communities as an aggregate, independent of our ability to culture individual microbes. Early studies focused on association of changes in gut microbiota with different disease states, which was necessary to identify a potential role for microbes and generate novel hypotheses. Over the past few years the field has moved beyond associations to better understand the mechanistic implications of the microbiome in the pathophysiology of complex diseases. This movement also has resulted in a shift in our focus toward therapeutic strategies, which rely on better understanding the mediators of gut microbiota-host cross-talk. It is not surprising the gut microbiome has been implicated in the pathogenesis of functional gastrointestinal disorders given its role in modulating physiological processes such as immune development, GI motility and secretion, epithelial barrier integrity, and brain-gut communication. In this review, we focus on the current state of knowledge and future directions in microbiome research as it pertains to functional gastrointestinal disorders. We summarize the factors that help shape the gut microbiome in human beings. We discuss data from animal models and human studies to highlight existing paradigms regarding the mechanisms underlying microbiota-mediated alterations in physiological processes and their relevance in human interventions. While translation of microbiome science is still in its infancy, the outlook is optimistic and we are advancing in the right direction toward precise mechanism-based microbiota therapies.

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Emerging Technologies to Investigate the Potential of Gut Microbiota in Human Health

Kumar,

Jedhe,

Choubey

et al. 2023

Role of Microbes in Sustainable Development

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742 - A Double-Blind, Randomized, Placebo-Controlled Trial of Fecal Microbiota Transplantation Capsules (FMTC) for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Cited by 25 publications

References 0 publications

Systematic review with meta‐analysis: efficacy of faecal microbiota transplantation for the treatment of irritable bowel syndrome

Systematic review with meta‐analysis: efficacy of faecal microbiota transplantation for the treatment of irritable bowel syndrome

The Gut Microbiome in Adult and Pediatric Functional Gastrointestinal Disorders

Emerging Technologies to Investigate the Potential of Gut Microbiota in Human Health

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