JMIR Publications

ABSTRACT

Background:

The long-term management of irritable bowel syndrome (IBS) poses many challenges. In short-term studies, electronic health (eHealth) interventions have been demonstrated as safe and practical for monitoring at home the effects of probiotic treatments and a low FODMAP diet (LFD). IBS has been linked to alterations in the microbiota.

Objective:

To determine whether a web-based LFD and probiotic treatment were equally good at reducing IBS symptoms, and whether the response to treatments could be explained by patients’ microbiota.

Methods:

Adult IBS patients were enrolled in an open-label, randomized crossover trial (for non-responders) with one year of follow-up using the web app, IBS Constant Care (CC). Patients were recruited from the outpatient clinic at the Department of Gastroenterology, North Zealand University Hospital, Denmark. Patients received either VSL#3® for four weeks (450 billion CFU b.i.d.) or were placed on a LFD for four weeks. Patients responding to the LFD were reintroduced to foods high in FODMAPs, and probiotic responders received treatments whenever they experienced a flare-up of symptoms. Treatment response and symptom flare-ups were defined as a reduction or increase, respectively, of at least 50 points on the IBS severity scoring system (IBS-SSS). Web ward rounds were performed daily by the study investigator. Fecal microbiota were analyzed by shotgun metagenomic sequencing (at least 10 million 2x100 bp paired-end sequencing reads per sample).

Results:

A total of 34 IBS patients without co-morbidities and six healthy controls were enrolled in the study. Taken from participating subjects, 180 fecal samples were analyzed for their microbiota composition. Twelve IBS patients responded to LFD (57%) and eight completed the reintroduction of FODMAPs (38%). Thirteen (62%) patients responded to their first treatment of VSL#3®, and seven (33%) responded to multiple VSL#3® treatments. A median of three (IQR: 2.25-3.75) probiotic treatments were needed for sustained symptom control. LFD responders were reintroduced to a median of 14.50 (IQR: 7.25; 21.75) high-FODMAP items. No significant difference in the median reduction of IBS-SSS for LFD vs. probiotic responders was observed, where for LFD it was -126.50 (IQR: -196.75; -76.75) and for VSL#3® it was -130.00 (IQR: -211.00; -70.50), P=1. Responses to either treatment were not able to be predicted using patients’ microbiota.

Conclusions:

Web-based LFD and probiotic treatment were equally efficacious in managing IBS symptoms. The response to treatments could not be explained by the composition of the microbiota. The CC web app was shown to be practical, safe and useful for clinical decision-making in the long-term management of IBS. Clinical Trial: Clinicaltrials.gov NCT03586622