Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial

Johnsen, Peter Holger; Hilpüsch, Frank; Cavanagh, Jorunn Pauline; Leikanger, Ingrid Sande; Kolstad, Caroline; Valle, Per Christian; Goll, Rasmus

doi:10.1016/s2468-1253(17)30338-2

Cited by 358 publications

(500 citation statements)

References 23 publications

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“…To date, there have been a total of 71 such studies investigating the role of FMT in IBD; of these, only four are prospective randomised controlled trials, limited to patients with ulcerative colitis 136–139. Five other reviewed randomised studies investigated the use of FMT in IBS,140 slow transit constipation,141 hepatic encephalopathy142 and metabolic syndrome 143 144…”

Section: Rationale For Recommendationsmentioning

confidence: 99%

“…In a double blind, placebo controlled RCT that recruited 90 patients with IBS with diarrhoea or with diarrhoea and constipation,140 the primary endpoint only just reached statistical significance in inducing symptom relief (as assessed by a 75 point reduction in IBS severity scoring system at 3 months following a single infusion FMT by colonoscopy) (P=0.049). The second RCT randomised 60 patients with slow transit constipation to either 6 consecutive days of nasogastric delivered FMT or conventional treatment 141.…”

Section: Rationale For Recommendationsmentioning

confidence: 99%

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The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Mullish

Quraishi

Segal

et al. 2018

Gut

273

187

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Interest in the therapeutic potential of faecal microbiota transplant (FMT) has been increasing globally in recent years, particularly as a result of randomised studies in which it has been used as an intervention. The main focus of these studies has been the treatment of recurrent or refractory infection (CDI), but there is also an emerging evidence base regarding potential applications in non-CDI settings. The key clinical stakeholders for the provision and governance of FMT services in the UK have tended to be in two major specialty areas: gastroenterology and microbiology/infectious diseases. While the National Institute for Health and Care Excellence (NICE) guidance (2014) for use of FMT for recurrent or refractory CDI has become accepted in the UK, clear evidence-based UK guidelines for FMT have been lacking. This resulted in discussions between the British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS), and a joint BSG/HIS FMT working group was established. This guideline document is the culmination of that joint dialogue.

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Section: Rationale For Recommendationsmentioning

confidence: 99%

Section: Rationale For Recommendationsmentioning

confidence: 99%

The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

Mullish

Quraishi

Segal

et al. 2018

Gut

273

187

View full text Add to dashboard Cite

show abstract

“…In one RCT among patients with moderate-to-severe IBS, higher response (p=0.049) rates at three months, defined as a 75point improvement in the IBS severity scoring system, were observed in patients receiving FMT (65%) compared to those receiving placebo (43%). 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).…”

Section: Functional Gi Disordersmentioning

confidence: 83%

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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“…Even so, it was the placebo, not the FMT group, that showed greater symptom relief ( P = .012) and improved QoL ( P = .003) . Another study by including 90 IBS patients found significant symptom improvement with freshly prepared, frozen FMT delivered through colonoscopy into the colon when compared to placebo ( P = .049) . These conflicting findings warrant the investigation of various factors which may contribute toward the efficacy of FMT, such as the method of bowel preparation, route of delivery, duration of treatment, and the number of fecal bacteria delivered.…”

Section: Fmtmentioning

confidence: 99%

Targeting the gut microbiota for the treatment of irritable bowel syndrome

Herndon

Wang

2019

The Kaohsiung J of Med Scie

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Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder that affects an estimated 11% of people across the world. IBS patients are one of the largest subgroups seen in gastroenterology clinics, exhibit a lesser quality of life, and take greater use of the healthcare system. The exact etiology of IBS remains uncertain. Alterations in the gut microbiome may characterize apotential mechanism in the pathogenesis of IBS. This hypothesis is paralleled by rodent models in which manipulation of the gut microbiota leads to disturbed physiological functions along the brain‐gut axis. Recent research in IBS treatments has redirected its focus towards gu microbiome based therapeutics. In this review, we discuss potential roles of enteric bacteria in the pathogenesis of IBS and its comorbidities. We then explore the manipulation of the enteric microbiota by prebiotics, probiotics, antibiotics, dietary changes, and fecal microbiota transfer. We also discuss the positive and negative effects of these therapeutics on IBS symptoms.

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Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial

Cited by 358 publications

References 23 publications

The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

The use of faecal microbiota transplant as treatment for recurrent or refractoryClostridium difficileinfection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

The Gut Microbiome in Adult and Pediatric Functional Gastrointestinal Disorders

Targeting the gut microbiota for the treatment of irritable bowel syndrome

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