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

Abstract

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.

Fecal Microbiota Changes in Patients With Postpartum Depressive Disorder

“…A number of scholars have supported and characterized “microbiome–gut–brain (MGB) axis” and illuminated a possible role of gut microbiota dysbiosis in a variety of diseases, such as obesity (Torres-Fuentes et al, 2017 ), inflammatory bowel disease (Lahtinen et al, 2020 ), and hypertension (Li et al, 2020 ). Although previous studies have demonstrated that microbial communities may influence our health, further attention needs to be paid to the potential associations between maternal gut microbiome and PPD.…”

Letter: faecal microbiota transplantation for irritable bowel syndrome—which improvements are required? Authors' reply

“…[3][4][5][6] We showed a mild transient benefit of FMT administered once via colonoscopy for irritable bowel syndrome (IBS) patients, although the difference was not significant when compared to placebo. 2 Still, FMT for this patient group shows promise, as also shown by the good results achieved in the clinical trial of El-Salhy et al, showing that a single FMT via gastroscopy resulted in a significant symptom reduction three months after treatment. 7 The good results were associated with careful donor selection and the healthy lifestyle of the donor was discussed.…”

“…We thank El-Salhy et al their interest in our study 1,2 and for contributing to the active discussion on how to improve the designs of future faecal microbiota transplantation (FMT) studies. [3][4][5][6] We showed a mild transient benefit of FMT administered once via colonoscopy for irritable bowel syndrome (IBS) patients, although the difference was not significant when compared to placebo.…”

“…We showed that a single FMT altered the microbiota composition although it did not result in sustained relief of symptoms. 2 To understand this phenomenon, we require further knowledge of the effective microbiota of the donor as well as the microbial community of the patient. The transplanted microbes may alter their activity as a result of different diet or host-microbe interaction in the new host.…”

Letter: faecal microbiota transplantation for IBS

“…We therefore suggest that future FMT-IBS studies have microbiome composition and functional analysis before and after FMT. We commend the authors for reporting both richness and composition Jonathan P. Segal 1,2 Benjamin H. Mullish 1,2 Mohammed Nabil Quraishi 3,4 Tariq H. Iqbal 3,4 1 Letter: faecal microbiota transplantation for irritable bowel syndrome. Authors' reply…”