Effects of Microencapsulated Sodium Butyrate, Probiotics and Short Chain Fructooligosaccharides in Patients with Irritable Bowel Syndrome: A Study Protocol of a Randomized Double-Blind Placebo-Controlled Trial

Background Irritable bowel syndrome (IBS) is a functional gastrointestinal disease in the pathogenesis of which the gut dysbiosis may play an important role. Thus, probiotics, prebiotics or microbiota metabolites such as butyric acid are considered to be an effective therapy in IBS, however still there is no trials presented efficacy of these three biotic components delivered to the patient simultaneously. This study aims to evaluate the effects of the combined formulation comprising sodium butyrate, probiotics and short chain fructooligosaccharides (scFOS) on the severity of clinical IBS symptoms and the quality of patients’ life (IBS-QOL). Methods This is randomized double-blind placebo-controlled trial included adults with IBS diagnosed according Rome IV criteria. Patients will be randomized in ratio 1:1 into the intervention group receiving a preparation of 300 mg of colon-targeted microencapsulated sodium butyrate, the mixture of Lactobacillus strains (L. rhamnosus and L. acidophilus) and Bifidobacterium strains (B. longum, B. bifidum, B. lactis) and 64mg of scFOS or into the control group receiving placebo containing maltodextrin. After 12 weeks of intervention the primary outcome will measure changes in IBS symptoms with the use of IBS-Symptom Severity Score (IBS-SSS), IBS-Global Improvement Scale (IBS-GIS), IBS-Adequate Relief (IBS-AR), and IBS-QOL. The secondary outcomes will be: type of stools, symptoms assessed in a patients’ diary, adverse events, anthropometric and nutritional measurements, levels of inflammatory cytokines. Discussion The findings will provide the first evidence for the use of a combination of three biotic compounds in IBS. Trial registration: The study was registered in the clinicaltrials.gov registry under the number NCT05013060.