Background/Objectives: To determine if consumption of yogurt containing a high dose of probiotic (1 Â 10 10 colony-forming unit per 100 ml), Bifidobacterium animalis subsp. lactis (B. lactis), decreases absences in children 2-4 years attending daycare/ school centers. Subjects/Methods: We conducted a double-blinded, randomized, placebo-controlled, allocation concealment clinical trial in the Washington, DC area. Our active intervention was a strawberry yogurt-based drink supplemented with B. lactis BB-12. The placebo was indistinguishable from the active drink, differing only in absence of the probiotic BB-12.Results: A total of 172 children between the ages of 2 and 4 from the Washington, DC area were enrolled. The primary outcome, missed days of school because of illness per 100 days, was similar in both the active (2.54 days absent/100 school days) and control groups (2.42 days absent/100 school days) (P ¼ 0.873). Conclusions: The probiotic-containing yogurt-based beverage studied did not decrease absences because of illnesses in daycare/school for healthy children ages 2-4 years.
Benefits associated with probiotic use have been reported; however, the mechanisms behind these benefits are poorly understood. The effects of a probiotic formulation (MegaDuo™) containing Bacillus coagulans SC208 and Bacillus subtilis HU58 on intestinal permeability and immune markers was assessed using a combination of the in vitro gut model, the mucosal simulator of the human intestinal microbial ecosystem (M-SHIME®), and an in vitro inflammatory bowel disease-like Caco-2/THP1 co-culture model in both healthy and antibiotic-induced dysbiosis conditions. Established M-SHIME® proximal colon vessels were treated with/without clindamycin (1 week) and then with/without daily MegaDuo™ treatment (2 weeks). The mucosal and luminal microbial communities were sampled weekly. Suspensions were removed from the proximal colon vessels after 1 and 2 weeks of MegaDuo™ treatment and added to the co-culture system. Transepithelial resistance (membrane barrier function), cytokine/chemokine release, and NFκB activity were then measured. Under conditions of antibiotic-induced dysbiosis, suspensions from MegaDuo™ treated vessels showed reduced gut membrane barrier damage and decreased levels of TNFα and IL-6 compared with suspensions from untreated vessels; no appreciable differences were observed under healthy conditions. MegaDuo™ treatment had no effect on NFκB activity of THP1-Blue™ cells. The potential benefits of MegaDuo™ treatment appeared most evident after 2 weeks of treatment.
Background. Hepatic encephalopathy often results in high blood ammonia levels because of inefficient ammonia processing by the liver. Lactulose treatment promotes the growth of urease-producing gut bacteria and a reduced colon pH, thus reducing blood ammonia absorption. It is thought that probiotics as an add-on therapy may be beneficial. Patients and Methods. Bacillus subtilis HU58 was tested for safety and tolerability in patients with hepatic encephalopathy taking lactulose in this double-bind, placebo-controlled, 4-week pilot study. Study participants received one dose of B. subtilis HU58 or placebo (orally) for the first five days and two daily doses thereafter. Participants were monitored for safety and blood ammonia levels. Results. Forty patients participated (placebo, 11; probiotic, 29). Baseline characteristics were generally comparable; the mean baseline blood ammonia level was somewhat higher in the probiotic group. Mild or moderate treatment-emergent adverse events (TEAEs) were reported in 27.3% and 17.2% of patients in the placebo and probiotic groups, respectively; no severe TEAEs were reported. One patient (9.1%) taking placebo and two (6.9%) taking the probiotic experienced serious TEAEs (SAEs); none resulted in study discontinuation and all were considered to have no/unlikely relationship to the study product. There were no significant differences in the mean percent change (MPC) of blood ammonia levels between groups, though the probiotic group exhibited a trend toward a milder increase. Stratification of the probiotic group by baseline blood ammonia level (>60 μg/dL and ≤60 μg/dL) resulted in a significantly reduced MPC in the >60 μg/dL subgroup (MPC (SD); ≤60 μg/dL (n = 14), 35.3% (73.3); >60 μg/dL (n = 14), −26.5% (24.4); p=0.0087). Conclusions. Daily treatment with oral B. subtilis HU58 was safe and well tolerated over a 4-week period in patients with hepatic encephalopathy, and a significantly reduced MPC of blood ammonia level was observed in patients with a baseline level >60 µg/dL.
GoodBiome™ Foods is a collection of foods infused with prebiotics, including inulin and xylooligosaccharides, and the probiotic Bacillus subtilis HU58. The effects of repeated intake of three predigested GoodBiome™ Foods products and one comparator product on microbial community activity and composition were assessed using the mucosal simulator of the human intestinal microbial system (M-SHIME®) platform with proximal colon (PC) and distal colon (DC) compartments and conducted under healthy gut conditions. Treatment with all test products increased short-chain fatty acid (SCFA) production (acetate, propionate, and butyrate) versus the control period in both the PC and DC. The highest increases were seen with the GoodBiome™ Foods products. Ammonium and branched SCFA levels were also increased (versus the control period) in both compartments. Treatment with all test products enhanced the Simpson diversity index (versus the control period), reaching significance for all test products in the PC (p < 0.05). Treatment with all test products resulted in changes in the microbial community composition. The relative abundance increased for Proteobacteria and decreased for Actinobacteria in the PC and DC. Repeated intake of GoodBiome™ Food products increased SCFA production and microbial diversity in an M-SHIME® model of the human intestinal microbiome.
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