Fecal microbiota transplantation on IBS related QoL & fatigue in moderate to severe non-constipated irritable bowel: Secondary endpoints, 2019,Johnsen

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Volume 51, January 2020, 102562

The effect of fecal microbiota transplantation on IBS related quality of life and fatigue in moderate to severe non-constipated irritable bowel: Secondary endpoints of a double blind, randomized, placebo-controlled trial
Author links open overlay panelPeter HolgerJohnsenae
FrankHilpüschbdPer ChristianValleaRasmusGollce
https://doi.org/10.1016/j.ebiom.2019.11.023Get rights and content
Under a Creative Commons license
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Abstract
Background
Severity in irritable bowel syndrome (IBS) is associated to impaired quality of life and fatigue. Fecal microbiota transplantation (FMT) induces significant relief in gastro-intestinal related complaints. The objective was to evaluate the effect of FMT on the secondary endpoints: IBS-related quality of life and fatigue in patients with non-constipated IBS.

Method
In this double-blind randomized placebo-controlled, parallel-group, single-center study, we enrolled patients with non-constipated IBS, defined by the ROME 3 criteria. We randomly assigned participants (2:1) in blocks of six to active or placebo FMT. Responder in fatigue and quality of life were defined as a decrease of 20 points in total Fatigue Impact Scale score, and improvement of 14 points in the IBS-quality of life questionnaire, respectively. In a modified-intention-to-treat population, we excluded participants who did not undergo treatment or who were diagnosed with any other disease by pinch biopsies during the treatment procedure.

Findings
Between Jan1, and Oct 30, 2015, we recruited 90 participants and randomly assigned them to active treatment (n = 60) or placebo (n = 30). Three participants did not undergo FMT and four were excluded after diagnosis of microscopic colitis, leaving 83 for final modified intention-to-treat analysis (55 in the active treatment group and 28 in the placebo group). Significant improvement in QoL (Odds ratio (OR) 3,801; confidence interval (CI) = 1,309–11,042 p = 0.011) and fatigue (OR = 4,398; CI = 1,175–16,468 and p = 0,020) was found at six months. Absence of other self reported functional disorders and presence of depression at baseline is suggested to predict a lasting effect of FMT in QoL and fatigue, respectively.

Interpretation
FMT induced significant relief in quality of life and fatigue. Results suggest a lasting effect of FMT in subgroups that should be further investigated in future studies. Funding Helse Nord, Norway and the Norwegian Centre of Rural Medicine, University of Tromsø, Norway.

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Keywords
Irritable bowel syndrome
Fecal microbiota transplantation
Quality of life
Fatigue
Bacterio therapy
Clinical trial

 

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Research in context

Evidence before this study
We searched PubMed for manuscripts published in English from inception and until Sept 20,2019, with the terms ‘’irritable bowel’’ in combination with ‘’fecal transplantation’’, ‘’fecal bacterio therapy’’, ‘’randomized controlled trial’’, ‘’dysbiosis’’, ‘’quality of life’’, ‘’fatigue’’, or ‘’microbiota’’. We identified five randomized controlled trials assessing the effect of fecal microbiota transplantation (FMT) in irritable bowel syndrome (IBS) with diverging results. Among others, differences in route and number of FMT administration, outcome measures, processing of transplants and criteria for inclusion of donors and FMT recipients can explain the lack of consistency in the results. Only one RCT with a single colonoscopic administration of FMT was identified (Holster et al. 2019, Clinical and Translational Gastroenterology). This study found a significant effect of FMT on IBS related quality of life in the donor FMT group, but not in the placebo group. There was not a significant difference between groups, but the study included only 17 patients. We could not find any studies assessing the effect of FMT on fatigue in IBS.

Added value of this study
The data show that FMT may improve quality of life and fatigue in IBS, in particular in the subgroups with no excessive functional comorbidity and self reported depression, respectively. The study also highlight fatigue as a part of IBS symptomatology, and available for therapeutic interventions.

Implications of all the available evidence
The study, combined with our previous reported result, show that there is a consistent effect of FMT in bowel related complaints, quality of life and fatigue in IBS. In future studies an effort should be made to determine which IBS subgroups benefit from FMT treatment.

 

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In a self-assessment questionnaire before FMT treatment, we asked patients to report disorders that are associated to the severity in IBS [4]. This included other functional disorders (fibromyalgia, chronic fatigue syndrome, jaw and pelvic pain syndromes) and mood disorders (anxiety and depression).