A Novel Mobile App (Heali) for Disease Treatment in Participants With Irritable Bowel Syndrome: Randomized Controlled Pilot Trial

Abstract

Background: A diet high in fermentable, oligo-, di-, monosaccharides and polyols (FODMAPs) has been shown to exacerbate symptoms of irritable bowel syndrome (IBS). Previous literature reports significant improvement in IBS symptoms with initiation of a low FODMAP diet (LFD) and monitored reintroduction. However, dietary adherence to the LFD is difficult, with patients stating that the information given by health care providers is often generalized and nonspecific, requiring them to search for supplementary information to fit their needs.

Objective: The aim of our study was to determine whether Heali, a novel artificial intelligence dietary mobile app can improve adherence to the LFD, IBS symptom severity, and quality of life outcomes in adults with IBS or IBS-like symptoms over a 4-week period.

Methods: Participants were randomized into 2 groups: the control group (CON), in which participants received educational materials, and the experimental group (APP), in which participants received access to the mobile app and educational materials. Over the course of this unblinded online trial, all participants completed a battery of 5 questionnaires at baseline and at the end of the trial to document IBS symptoms, quality of life, LFD knowledge, and LFD adherence.

Results: We enrolled 58 participants in the study (29 in each group), and 25 participants completed the study in its entirety (11 and 14 for the CON and APP groups, respectively). Final, per-protocol analyses showed greater improvement in quality of life score for the APP group compared to the CON group (31.1 and 11.8, respectively; P=.04). Reduction in total IBS symptom severity score was 24% greater for the APP group versus the CON group. Although this did not achieve significance (-170 vs -138 respectively; P=.37), the reduction in the subscore for bowel habit dissatisfaction was 2-fold greater for the APP group than for the CON group (P=.05).

Conclusions: This initial study provides preliminary evidence that Heali may provide therapeutic benefit to its users, specifically improvements in quality of life and bowel habits. Although this study was underpowered, findings from this study warrant further research in a larger sample of participants to test the efficacy of Heali app use to improve outcomes for patients with IBS.

Trial registration: ClinicalTrials.gov NCT04256551; https://clinicaltrials.gov/ct2/show/NCT04256551.

Keywords: artificial intelligence; irritable bowel syndrome; low FODMAP diet; mobile app; randomized controlled trial.

Figure 1

CONSORT (Consolidated Standards of Reporting Trials) flow diagram. APP: experimental group (access to artificial intelligence dietary mobile app); CON: control group.

Figure 2

Thirty-day change (mean±SD) in IBS-SSS scores by question. APP: experimental group (access to artificial intelligence dietary mobile app); CON: control group; IBS-SSS: irritable bowel syndrome symptom severity scale; Q1: abdominal pain severity; Q2: abdominal pain frequency; Q3: abdominal pain distension severity; Q4: bowel habit dissatisfaction; Q5: quality of life interference due to the aforementioned symptoms. *Significant difference between CON and APP groups (P=.05, Mann-Whitney U test).