Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial

Abstract

BackgroundLactose intolerance (LI) is a common medical problem with limited treatment options. The primary symptoms are abdominal pain, diarrhea, bloating, flatulence, and cramping. Limiting dairy foods to reduce symptoms contributes to low calcium intake and the risk for chronic disease. Adaptation of the colon bacteria to effectively metabolize lactose is a novel and potentially useful approach to improve lactose digestion and tolerance. RP-G28 is novel galacto-oligosaccharide (GOS) being investigated to improve lactose digestion and the symptoms of lactose intolerance in affected patients.MethodsA randomized, double-blind, parallel group, placebo-controlled study was conducted at 2 sites in the United States. RP-G28 or placebo was administered to 85 patients with LI for 35 days. Post-treatment, subjects reintroduced dairy into their daily diets and were followed for 30 additional days to evaluate lactose digestion as measured by hydrogen production and symptom improvements via a patient-reported symptom assessment instrument.ResultsLactose digestion and symptoms of LI trended toward improvement on RP-G28 at the end of treatment and 30 days post-treatment. A reduction in abdominal pain was also demonstrated in the study results. Fifty percent of RP-G28 subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment and 30 days post treatment (p = 0.0190). RP-G28 subjects were also six times more likely to claim lactose tolerance post-treatment once dairy foods had been re-introduced into their diets (p = 0.0389).ConclusionsEfficacy trends and favorable safety/tolerability findings suggest that RP-G28 appears to be a potentially useful approach for improving lactose digestion and LI symptoms. The concurrent reduction in abdominal pain and improved overall tolerance could be a meaningful benefit to lactose intolerant individuals.Study registrationClinicalTrials.gov NCT01113619.

Impact of short-chain galactooligosaccharides on the gut microbiome of lactose-intolerant individuals

“…The clinical trial included subjects who consumed GOS but refrained from consuming dairy for 36 d, then stopped GOS consumption and reintroduced dairy into their diets for 30 additional days, until day 66. The changes in microbiome composition reported here included increases in lactose-fermenting Bifidobacterium, Lactobacillus, and Faecalibacterium, and those changes correlated with an improvement of symptoms for lactose-intolerant subjects who were participating in the study (4). In this aligned clinical study, 50% of the subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment with GOS (at day 36), and at 30 d posttreatment (at day 66) (P = 0.0190).…”

“…Eligible subjects were required to demonstrate a minimum symptom score and a positive HBT to be eligible for randomization. Exclusion criteria included diabetes mellitus, GI motility disorders, irritable bowel syndrome, inflammatory bowel diseases, celiac disease, and surgery that altered the normal function of the GI tract (4). During the clinical trial, participants avoided lactose in their diets and received escalating doses of high-purity (>95%) GOS or placebo (Sweetose) in 5-d increments according to a fixed schedule from 1.5 g/d to 15 g/d.…”

“…An overview of the original study design has been reported previously (4). The study was a randomized, double-blind, parallelgroup, placebo-controlled study conducted at two sites in the United States.…”

“…Savaiano et al conducted a randomized, double-blind, parallel-group, placebocontrolled study at two sites in the United States (4). A high purity (>95%) galactooligosaccharide (GOS/RP-G28) or a placebo (Sweetose; Tate & Lyle Ingredients) was administered in increasing doses to 62 lactose-intolerant subjects for 36 d. Subjects refrained from consuming lactose during the GOS treatment period.…”

Gut Microbiota and Nonalcoholic Fatty Liver Disease: Insights on Mechanism and Therapy

“…In clinic, prebiotics have also been trialed for their benefits in various diseases [127][128][129][130][131]. Oligofructose (OFS), an inulin-type fructans, were added to diet for patients with NASH in a pilot randomized double-blind study [118].…”