Effects of combined prebiotic, probiotic, IgG and amino acid supplementation on the gut microbiome of patients with inflammatory bowel disease.

Background: The effects of the Total Gut Restoration (TGR) system supplementation on the gut microbiome were evaluated. Materials & methods: A mucosal in vitro simulation of the human gastrointestinal tract (M-SHIME®) system was inoculated with fecal samples from patients with inflammatory bowel disease. Chambers were supplemented for 5 days with the TGR system (five probiotic Bacillus strains, prebiotic mixture, immunoglobulin concentrate, amino acids and prebiotic flavonoids). Results: Compared with unsupplemented controls, supplementation was associated with a significant increase in short-chain fatty acid production, and changes to the microbiome were observed. Supernatants from supplemented chambers improved intestinal barrier function, increased IL-6 and IL-10 production and decreased MCP1 production versus control in Caco-2/THP1 coculture. Conclusion: Daily TGR supplementation facilitated changes to the gut microbiome of patients with inflammatory bowel disease.

The Total Gut Restoration (TGR) system includes spore-based probiotics, prebiotics and a combination of immunoglobulins and amino acids. Each of these supplements has individually shown benefits for the health of the gut microbiome. We assessed the effects of daily supplementation with all TGR system components over 5 days in a laboratory simulation of the human gastrointestinal tract. We used fecal samples from patients with inflammatory bowel disease to learn whether supplementation would result in any changes to the gut microbiome in these patients. We evaluated changes in the production of short-chain fatty acids (considered beneficial for gut health) and changes in the composition of the gut microbiome before and after 5 days of TGR supplementation. There were significant increases in short-chain fatty acid production and changes to the microbiome that are considered to be beneficial to human health. These findings demonstrate that daily TGR supplementation may facilitate beneficial changes to the gut microbiome of patients with inflammatory bowel disease.

An Oral Formulation of the Probiotic, Bacillus subtilis HU58, Was Safe and Well Tolerated in a Pilot Study of Patients with Hepatic Encephalopathy.

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.