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Novel prebiotic shows promise in lactose intolerance
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Patients with lactose intolerance who received RP-G28, a high purity short-chain galactooligosaccharide prebiotic, experienced clinical improvements that correlated with significant alterations in their gut microbiome, according to the results of a randomized controlled trial.
“This is a seminal study producing some of the first data in lactose intolerance showing the microbiome’s role in being able to metabolize lactose independent of host enzymes,” M. Andrea Azcarate-Peril, PhD, from the department of medicine, and director of the Microbiome Core Facility, School of Medicine, University of North Carolina, Chapel Hill, said in a press release. “Furthermore, it’s remarkable that we observed a definitive shift to being lactose tolerant after a single 35-day dosing of RP-G28.”
Azcarate-Peril and colleagues performed a phase 2a multicenter, double blind, randomized placebo-controlled trial of 85 patients with lactose intolerance to determine the clinical response and changes in the fecal microbiome resulting from RP-G28 (Ritter Pharmaceuticals). They randomly assigned 57 patients to consume RP-G28 and 28 patients to consume placebo before consuming dairy foods for 35 days, and afterward patients stopped taking RP-G28 or placebo and regularly introduced dairy products into their diet for 30 days. The researchers collected and analyzed stool samples before and after treatment and after the 30 days of regular dairy consumption.
16S rRNA amplicon pyrosequencing and high-throughput quantitative PCR showed RP-G28 significantly altered the composition of the gut microbiome. After RP-G28 treatment, 90% of patients had increased bifidobacterial populations; in contrast, previous studies of RP-G28 showed only a 50% bifidogenic response.
Additionally, RP-G28-treated individuals showed significantly increased relative abundances of lactose-fermenting Bifidobacterium, Lactobacillus and Faecalibacterium, with the third suggesting RP-G28 “might have potential therapeutic benefits in inflammatory bowel disease and metabolic syndrome, among other diseases,” according to the press release.
The lactose-fermenting species Roseburia also increased following reintroduction of dairy into the diet.
These microbial changes also correlated with improvement of clinical symptoms, with 71% reporting improvement of at least one symptom (pain, bloating, diarrhea, cramping or flatulence) after 33 days of treatment, and 69% reporting symptom relief at day 66 after diary reintroduction.
“Demonstrating that RP-G28 can increase key lactose-fermenting bacteria associated with symptom improvements sheds light on potential mechanisms of action for treating lactose intolerance,” Andrew J. Ritter, president of Ritter Pharmaceuticals, said in the press release. “The results of this analysis are consistent with our hypothesis of how the therapeutic may work and increases our confidence that it will be an effective option for patients seeking solutions for their lactose intolerance.”
A phase 2b/3 clinical trial of RP-G28 in 377 patients is ongoing, with results expected this year, according to the press release. – by Adam Leitenberger
Disclosures: Ritter is the founder of Ritter Pharmaceuticals, which funded the study, and two of the researchers report they are on the advisory board.
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