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

Abstract

Irritable bowel syndrome (IBS) is a functional gastrointestinal disease in the pathogenesis of which gut dysbiosis may play an important role. Thus, probiotics, prebiotics, or microbiota metabolites, such as butyric acid, are considered to be effective therapy for IBS. However, there are still no trials presenting the efficacy of these three biotic components administered simultaneously. This study aims to evaluate the effects of the product comprising sodium butyrate, probiotics, and short-chain fructooligosaccharides (scFOS) on the severity of clinical IBS symptoms and the quality of life (IBS-QOL). This is a randomized double-blind placebo-controlled trial conducted in 120 adults with IBS diagnosed according to Rome IV criteria. The intervention group (n = 60) will receive a mixture of the following components: 300 mg of colon-targeted microencapsulated sodium butyrate combined with probiotic Lactobacillus strains (L. rhamnosus and L. acidophilus) and Bifidobacterium strains (B. longum, B. bifidum, B. lactis), and 64 mg of prebiotic scFOS. The control group (n = 60) will receive a placebo (maltodextrin). The primary outcomes will be changes in IBS symptoms with the use of the IBS-Severity Scoring System (IBS-SSS), IBS-Global Improvement Scale (IBS-GIS), IBS-Adequate Relief (IBS-AR), and IBS-QOL after 12 weeks of intervention. The secondary outcomes will be the type of stools, patient-recorded symptoms, adverse events, anthropometric and nutritional parameters, and inflammatory cytokine levels. The findings will provide the first evidence of the use of a combination of three biotic compounds in IBS. The study was registered in the clinicaltrials.gov registry under the number NCT05013060.

Delivery Strategies of Probiotics from Nano- and Microparticles: Trends in the Treatment of Inflammatory Bowel Disease—An Overview

“…Results showed the preparation of 1.1 µm microparticles with excellent ROS scavenging ability in cell experiments and a 40% reduction in disease activity index scores in animal experiments (Figure 4D) [131]. In fact, multicomponent microencapsulation could generate better results, as reported by G ąsiorowska et al The authors showed a clinical study using sodium butyrate microparticles, probiotics, and short-chain fructooligosaccharides in patients with Irritable Bowel Syndrome (IBS), a functional gastrointestinal disorder that can cause symptoms similar to IBD but without damaging the gastrointestinal tract [132]. Probiotics used were two Lactobacillus strains (L. rhamnosus and L. acidophilus) and three Bifidobacterium strains (B. longum, B. bifidum, and B. lactis), and results showed that this combination could be beneficial for an alternative treatment of IBD, as it restores the disturbed functionality of the intestinal microbiota [115].…”

From the Perspective of Computer Engineering: Research on Digestive Diseases based on Bioinformatics and Genetic Genetics

“…Using a feedback artificial neural network designed for a certain problem and giving full play to the high-speed computing ability of the computer, the optimal solution may be found quickly. This technology can be applied in clinical medicine to detect the pathogenesis of gastroenterologyneuroscience [1][2][3][4][5].…”