Efficacy of a self-management program using an eHealth system to reduce symptom severity in patients with irritable bowel syndrome simultaneously with changes in gut microbiota: a randomized controlled trial

Objective This study aimed to evaluate whether a self-management program using the eHealth system could reduce symptom severity in patients with irritable bowel syndrome (IBS). Impact of the intervention on quality of life and gut microbiota were also examined. Design This study was designed as an open label, simple randomized controlled trial comparing an intervention group that attended an eHealth self-management program and a treatment as usual group. Participants were Japanese women between the ages of 18 and 36. Forty symptomatic IBS individuals who met the inclusion criteria were recruited and randomly assigned to the two groups. The eHealth group received 8 weeks of unlimited access to the self-management program containing a wide variety of e-learning content. Participants’ severity of IBS symptoms, the main outcome, was assessed using the irritable bowel syndrome-severity index (IBS-SI) at baseline and 8 weeks. The secondary outcomes of participants’ quality of life and gut bacteria were also assessed at baseline and week 8. Results There was a significant difference in the net change in IBS severity index (IBS-SI) score between the eHealth and treatment as usual group (−50.1; 95% CI, −87.6 to -12.6; p = 0.010). The eHealth group had significantly lower IBS-SI scores following 8 weeks of intervention compared with the baseline scores (t = − 3.2, p < 0.01). The implementation of the eHealth program was accompanied by improvement of quality of life and decrease of phylum-level Cyanobacteria occupancy, respectively. Conclusion The implementation of eHealth for IBS was shown to reduce IBS symptoms. Key Messages ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial UMIN Clinical Trials Registry, UMIN000042552 ### Clinical Protocols ### Funding Statement This work was funded by the Japan Society for the Promotion of Science (JSPS) for the Fostering Joint International Research (B) (No. 18KK0275) ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: the Ethics Committee of Saitama Prefectural University (no. 20048) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data relevant to the study are included in the article or uploaded as supplementary information.