DUGi

Impact of combined low-fodmap diet and probiotic supplementation on gut microbiome and symptom severity in irritable Bowel syndrome

http://dugi.udg.edu/item/http:@@@@hdl.handle.net@@10256@@28684

BACKGROUND: Irritable bowel syndrome (IBS) is a prevalent functional gastrointestinal disorder characterised by abdominal pain and altered bowel habits, significantly impacting quality of life. Its pathophysiology involves disordered motility, visceral hypersensitivity, mild inflammation, gut-brain axis dysregulation and gut microbiota alterations. Dietary interventions, especially the Low-FODMAP diet, can reduce symptoms, while probiotics may restore microbial balance and modulate immune responses. Combining these strategies may enhance symptom relief, improve quality of life, and modulate gut microbiota and inflammation. OBJECTIVES: The main objective of the study is to determine the effectiveness of the Low-FODMAP diet combined with the probiotic, in improving gut dysbiosis in IBS patients, assessed by the RAID-Dx test, compared with the low-FODMAP diet alone and the probiotic alone. Secondary objectives include assessing improvement in IBS symptom severity (IBS-SSS), quality of life (IBS-QOL), psychological symptoms (HADS), dietary adherence, safety, inflammatory biomarkers (CRP, faecal calprotectin) and exploring correlations between dysbiosis improvement and these clinical outcomes. DESIGN AND SETTING: Multicentre, randomised, controlled, longitudinal clinical trial conducted at Hospital Dr. Josep Trueta and Hospital Santa Caterina (Girona) over 2 years and 6 months. Three interventions will be compared: Low-FODMAP diet, probiotic and Low-FODMAP diet combined with the probiotic. PARTICIPANTS AND METHODS: A total of 198 patients aged 18–65 with confirmed IBS will be recruited consecutively and randomised 1:1:1 to the three interventions. The dietary intervention and probiotic administration are open-label, whereas data manager and statisticians are blinded. Primary outcome is improvement in gut dysbiosis, assessed by RAID-Dx, in faecal samples collected at baseline, 2 and 6 months; and compared with samples from 10 healthy controls. Secondary outcomes include improvement in IBS-SSS, IBS-QOL, HADS, CRP, faecal calprotectin, dietary adherence and safety. The Low-FODMAP diet follows restriction, reintroduction, and personalisation phases; while probiotics are administered daily for 8 weeks during the restriction phase

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