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

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) = 1,309À11,042 p = 0.011) and fatigue (OR = 4,398; CI = 1,175À16,468 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

Effect of fecal microbiota transplant on symptoms of psychiatric disorders: a systematic review

“…Huang et al and Johnsen et al assessed quality of life using the IBS-QOL scale. Scores on this questionnaire followed a similar pattern as the assessments above, with a significant improvement being observed during the first 3 to 6 months and returning to baseline after 6 to12 months [45,49]. Johnsen et al also found a similar effect on fatigue, with improvement up to 6 months after FMT and a waning effect from 6 to 12 months [49].…”

Molecular Mechanisms of Microbiota-Mediated Pathology in Irritable Bowel Syndrome

“…Treatment strategies targeting enteric microbiota, including antibiotics, pre-/pro-/symbiotics, a low-FODMAP (fermentable oligo-, di-, mono-saccharides, and polyols) diet, and fecal microbiota transplantation (FMT), have been found to be effective in certain populations [ 45 , 57 ]. Particularly, FMT appears to be one of the most powerful modalities to reverse dysbiosis and potentially induces long-lasting remission of IBS [ 58 , 59 ]. Recent study demonstrated that utilizing a well-defined donor with a normal dysbiosis index and favorable specific microbial signature is important for successful FMT in IBS patients [ 60 ].…”

The role of faecal microbiota transplantation: looking beyond Clostridioides difficile infection

“…The current evidence base for the effect of FMT in psychiatric disorders (predominantly anxiety and depression) has been previously summarised. 97 The overwhelming majority of in-human studies have enrolled patients with concurrent IBS [98][99][100][101][102] or are limited to case reports, [103][104][105] with only one study 98 involving a control group and blinding, making it difficult to draw firm conclusions at present. Improvements were seen in depression, anxiety, quality-of-life and fatigue scores, although the effect may only be transient.…”