Leonilde Bonfrate1, Domenica M Di Palo1,2, Giuseppe Celano2, Adelin Albert3, Paola Vitellio1,2, Maria De Angelis2, Marco Gobbetti4, Piero Portincasa1. 1. Clinica Medica "A. Murri", Department of Biomedical Sciences & Human Oncology, University of Bari Medical School, Bari, Italy. 2. Department of Soil, Plant and Food Sciences, Università degli Studi di Bari Aldo Moro, Bari, Italy. 3. Department of Biostatistics, University Hospital of Liège, Liège, Belgium. 4. Faculty of Science and Technology, Free University of Bolzano, Bolzano, Italy.
Abstract
BACKGROUND:Irritable bowel syndrome (IBS) is a common gastrointestinal disorder, which still lacks effective therapy. We aimed to investigate the effects of a novel formulation of Bifidobacterium longum BB536 and Lactobacillus rhamnosus HN001 with vitamin B6 (LBB) on symptoms, intestinal permeability, cultivable bacteria and metabolome in IBS subjects. MATERIALS AND METHODS:Twenty-five IBS patients (Rome IV criteria) (M:F = 8:17; age 48 years ± 11 SD) were randomized to treatment (LBB) or placebo (one month each) in a crossover randomized double-blind controlled trial. Symptoms, intestinal habits, disease severity, intestinal permeability and intestinal microbiota were analysed at 0, 30, 45 and 60 days. RESULTS: Percentage decrease from baseline of abdominal pain (-48.8% vs -3.5%), bloating (-36.35% vs +7.35%) and severity of disease (-30.1% vs -0.4%) was significantly (P < .0001) greater with LBB than placebo, respectively. In IBS-D patients, the improvement from baseline of Bristol score was more consistent with LBB (from 6 ± 0.4 to 4.3 ± 1.1, P < .00001) than placebo (from 6.2 ± 0.7 to 5.3 ± 1.1, P = .04). In IBS-C patients, Bristol score tended to improve from baseline after LBB (2.6 ± 1.1 vs 3.2 ± 0.5, P = .06). LBB significantly improved the percentage of sucralose recovery (colonic permeability) (1.86 ± 0.1 vs 1.1 ± 0.2, P = .01). During treatment, presumptive lactic acid bacteria and bifidobacteria, relative abundance of propanoic, butanoic, pentanoic acids and hydrocarbons increased, while phenol decreased. CONCLUSIONS: The novel formulation of B. longum BB536 and L. rhamnosus HN001 with B6 vitamin improves symptoms and severity of disease, restores intestinal permeability and gut microbiota in IBS patients.
RCT Entities:
BACKGROUND:Irritable bowel syndrome (IBS) is a common gastrointestinal disorder, which still lacks effective therapy. We aimed to investigate the effects of a novel formulation of Bifidobacterium longumBB536 and Lactobacillus rhamnosus HN001 with vitamin B6 (LBB) on symptoms, intestinal permeability, cultivable bacteria and metabolome in IBS subjects. MATERIALS AND METHODS: Twenty-five IBSpatients (Rome IV criteria) (M:F = 8:17; age 48 years ± 11 SD) were randomized to treatment (LBB) or placebo (one month each) in a crossover randomized double-blind controlled trial. Symptoms, intestinal habits, disease severity, intestinal permeability and intestinal microbiota were analysed at 0, 30, 45 and 60 days. RESULTS: Percentage decrease from baseline of abdominal pain (-48.8% vs -3.5%), bloating (-36.35% vs +7.35%) and severity of disease (-30.1% vs -0.4%) was significantly (P < .0001) greater with LBB than placebo, respectively. In IBS-D patients, the improvement from baseline of Bristol score was more consistent with LBB (from 6 ± 0.4 to 4.3 ± 1.1, P < .00001) than placebo (from 6.2 ± 0.7 to 5.3 ± 1.1, P = .04). In IBS-C patients, Bristol score tended to improve from baseline after LBB (2.6 ± 1.1 vs 3.2 ± 0.5, P = .06). LBB significantly improved the percentage of sucralose recovery (colonic permeability) (1.86 ± 0.1 vs 1.1 ± 0.2, P = .01). During treatment, presumptive lactic acid bacteria and bifidobacteria, relative abundance of propanoic, butanoic, pentanoic acids and hydrocarbons increased, while phenol decreased. CONCLUSIONS: The novel formulation of B. longumBB536 and L. rhamnosus HN001 with B6 vitamin improves symptoms and severity of disease, restores intestinal permeability and gut microbiota in IBSpatients.
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