Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial

Aroniadis, Olga C.; Brandt, Lawrence J.; Oneto, Caterina; Feuerstadt, Paul; Sherman, Alex; Wolkoff, Allan W.; Kassam, Zain; Sadovsky, Rotem Gura; Elliott, Ryan J.; Budree, Shrish; Kim, Mimi; Keller, Marla J.

doi:10.1016/s2468-1253(19)30198-0

Cited by 116 publications

(230 citation statements)

References 35 publications

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“…High‐response rates to placebo are typical in IBS studies, 38 but also bowel cleansing may have impacted on the IBS symptoms. Collectively, the FMT trials carried out on IBS patients thus far have shown promising results in terms of the microbiota modulation, although the effects on symptoms have been inconsistent 17‐21 . Consequently, gut microbiota remains a potential target for the treatment in IBS.…”

Section: Discussionmentioning

confidence: 99%

“…We recruited 55 patients and aimed to include minimum of 52 patients based on the power calculation, but finally excluded six due to exclusion criteria and thus 49 patients were left for final analysis. The previously published placebo‐controlled trials of FMT in IBS have had patient sizes ranging from 17 to 165 17‐21 . Furthermore, we allowed patients with any IBS subtype or any grade of severity to participate in the study, in comparison to the study of Johnsen et al in which constipation predominant IBS patients were excluded 17 .…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, an optimal donor might result in a better response rate also in IBS, as was previously demonstrated for ulcerative colitis in a study where the desired treatment outcome was obtained in only one out of six donors 41 . It may well be that differences in the donor microbiota explain the superior efficacy of FMT in IBS, as demonstrated in the study of El‐Salhy et al 21 as compared to all previous studies, 17‐20 including ours.…”

Section: Discussionmentioning

confidence: 99%

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Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome

Lahtinen

Jalanka

Hartikainen

et al. 2020

Aliment Pharmacol Ther

198

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Background: Irritable bowel syndrome (IBS) has been associated with microbial dysbiosis. Aim: To investigate the efficacy of faecal microbiota transplantation (FMT) in the treatment of IBS. Methods: Forty-nine IBS patients were randomised to receive autologous or allogenic FMT via colonoscopy. The primary endpoint was a sustained, minimum of 50point, reduction in the IBS Symptom Severity Score. The secondary outcomes were levels of anxiety and depression, changes in quality of life, gut microbiota and faecal water content as assessed with validated questionnaires, intestinal microbiota composition and stool dry weight.Results: The primary endpoint was not achieved in either group. However, there was a transient reduction in the mean IBS Symptom Severity Score in the FMT group at 12 weeks after treatment as compared to baseline (P = 0.01). The groups did not differ in the number of patients achieving clinical response at 12 weeks. In the FMTtreated patients, microbial composition had changed to resemble that of the donor and the stool water content decreased significantly compared to baseline. The depression score decreased in patients with a reduction in IBS symptoms after FMT, but not in those placebo-treated patients who experienced a reduction in IBS symptoms. Conclusions: FMT provided only a transient relief of symptoms, although it induced a sustained alteration in the microbiota of IBS patients. Therefore, FMT delivered by a single infusion via colonoscopy cannot be recommended as a treatment for IBS in clinical practice. ClinicalTrials.Org, Trial registration number: NCT03561519.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome

Lahtinen

Jalanka

Hartikainen

et al. 2020

Aliment Pharmacol Ther

198

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“…5 When looking at specific randomised controlled trials, one for IBS-D found that placebo was no better than FMT at inducing symptom relief. 6 Hence, FMT for functional symptoms became a less attractive research proposition. However, this was later challenged with a strongly positive study for FMT in IBS that used a single 'super donor'.…”

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confidence: 99%

Letter: faecal microbiota transplantation for IBS

Segal

Mullish

Quraishi

et al. 2020

Aliment Pharmacol Ther

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“…FMT as an initial therapy for CDAD has been explored and approaches to the treatment of severe CDAD, including pseudomembranous colitis, developed. Hints of efficacy in ulcerative colitis and IBS as well as a myriad of intestinal and extraintestinal disorders have emerged, supported by evidence that has ranged widely in quality and quantity . It is noteworthy, but not surprising, given the fundamental role of the microbiota in CDAD, that results in other indications, of varying phenotype and unclear pathophysiology, have been less impressive, or even negative.…”

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confidence: 99%