Unlocking Relief: A Pilot Investigation of the Impact of a Probiotic, Enzyme, and Melissa Officinalis Combination on Bloating and Digestive Wellness in IBS Patients
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Background: Functional gastrointestinal disorders, including irritable bowel syndrome (IBS) and functional abdominal bloating, are prevalent in gastroenterology. The unclear pathogenesis complicates the development of effective therapies, which may be pharmacological or non-pharmacological in nature. Objective: This pilot study aimed to evaluate the efficacy of a food supplement containing probiotics, digestive enzymes, and Melissa officinalis extract in patients suffering from IBS and functional abdominal bloating. Methods: We conducted a randomized, double-blind, placebo-controlled, monocentric trial involving adult patients diagnosed with IBS and functional abdominal bloating. Participants were randomly assigned to receive either the active product or a placebo for 20 days. The primary outcome measure was the change in the global Visual Analogue Scale (VAS) for satisfaction. Secondary measures included symptom scales related to bloating and abdominal pain. Results: A total of 31 participants were enrolled, with 29 completing the study. Patients receiving the active supplement reported a positive effect in the global VAS for satisfaction and demonstrated improvement in most secondary symptom scales compared to the placebo group. However, no statistically significant differences were found between the active and placebo groups, the treatment resulted in a higher tendency to improvement in patient-reported outcomes compared to the placebo group. Conclusion: This pilot study provides valuable insights into non-pharmacological therapies for IBS and functional abdominal bloating. Although the results were promising, larger studies with longer treatment durations and based on more complex approach also including diet intervention and psychological support are needed to fully evaluate the long-term effects of probiotics and the active ingredients in the supplement.