The Efficacy of Sodium Butyrate and Probiotics in Patients With Irritable Bowel Syndrome
The Efficacy of Sodium Butyrate and Probiotics in Patients With Irritable Bowel Syndrome
NCT ID: NCT05013060 Phase: NA Status: COMPLETED Enrollment: 120 Completion: 2024-01-31
Conditions
Irritable Bowel Syndrome
Interventions
Probiotics and microcapsulated sodium butyrate, Maltodextrin
Summary
According to current IBS management guidelines, probiotic administration reduces IBS-associated symptoms and improves the quality of life. The purpose of this study is to assess the effects of the combined formulation comprising microencapsulated sodium butyrate and a probiotic mixture of two Lactobacillus strains (L. rhamnosus and L. acidophilus) and three Bifidobacterium strains (B. longum, B. bifidum, and B. lactis) on the incidence and severity of clinical symptoms in patients diagnosed with irritable bowel syndrome (IBS) based on the Rome IV criteria.
Microencapsulated sodium butyrate is a short-chain fatty acid (SCFA) with biological effects on the gastrointestinal mucosa; it constitutes a key source of energy for enterocytes. Butyrate was shown to have a trophic effect on the colon epithelium and to help restore the disrupted structural and functional integrity of the gastrointestinal tract. These unique properties of sodium butyrate result in its beneficial effects on the abdominal symptoms (such as diarrhea, constipation, abdominal pain) in patients with IBS. This study will assess the effects of the mixture of sodium butyrate and multi-strain probiotic on the rate and severity of clinical symptoms in IBS patients, by taking into account their nutritional status and body composition.
Primary Outcome
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)