PROMOTION AND MONITORING OF PHYSICAL ACTIVITY WITH A DIGITAL APP IN PATIENTS WITH IRRITABLE BOWEL SYNDROME: CLINICAL OUTCOMES AND FECAL MICROBIOTA ANALYSIS OF A RANDOMIZED CONTROLLED STUDY

Background and Aim: Physical activity (PA) improves irritable bowel syndrome (IBS) symptoms. Digital Apps may increase PA, but whether this intervention can improve symptoms in patients with IBS has not yet been investigated. Gut microbiota plays an important role in IBS. The aim of this randomized controlled trial was to evaluate the effects of PA prescription with the use of a mobile App. Methods: We enrolled 97 consecutive patients with IBS according to Roma IV criteria; 22 patients aged <18/>60 years or with comorbidities limiting PA were excluded. Patients were randomized to two intervention groups: 1) (Not APP) PA prescription with a 10 min counselling or 2) (APP) PA prescription with the indication to use the mobile App Google Fit after a brief explanation. Patients were evaluated at the first visit (T0) and after 3 months (T3). The severity of IBS symptoms (primary endpoint) was assessed by the Irritable Bowel Severity Scoring System (IBS-SSS). The Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS), the Hospital Anxiety and Depression Scale (HADS), and the Bristol Stool Scale (BSS) were also used. The adherence to WHO guidelines for aerobic physical activity, and PA levels were measured as Metabolic Equivalent of the Task (MET) minutes per week through the International Physical Activity Questionnaire–Short Form (IPAQ-SF). Microbiota analysis on stool was performed at T0 and T3 in a group of 50 patients. Results: Seventy-five patients with IBS (mean age 41, SD±11.7 years; 70% female) were randomized. Baseline characteristics of two groups were not significantly different. Three patients dropped out in the Not APP group. The improvement in IBS-SSS (88.2±67 vs 47.6±72.0, P=0.021) and in SAGIS total score 9.2±8.7 vs 4.1±8.7, P=0.021) was significantly greater for APP, whereas the difference of the improvement in HADS between groups remained at borderline significance level (4.3±5.0 vs 2.3±3.7, P=0.065). Normalization of stool form was observed in 21% in the Not APP group and in the 41% of patients in the APP group (P= 0.077). Although PA increased in both groups, the increase was greater in the APP than in the Not APP (MET min global activity at IPAQ-SF=791±1026 vs 262±807; P=0.025). The increase of PA was significantly correlated with the improvement of IBS-SSS (r=0.33, P=0.03). Changes in the gut microbiota composition were observed in IBS patients after physical activity. While alpha-diversity remained unchanged, beta-diversity showed significant shifts in microbial community structure from baseline to end of treatment (p=0.001). Specific genera were differentially enriched post-treatment, suggesting possible PA-induced modulation. At the species level, analysis revealed several enriched (amplicon sequence variants) ASVs after intervention. Conclusions: A digital APP promoting PA improved symptoms compared to PA counselling alone. Gut microbiota plays a role in symptom improvement, though it is not the sole driver. APP and increased activity may help shape microbial changes in conjunction with other factors to improve IBS symptoms.