A Novel Direct Butyrate Generator Reduces Belly Pain in a Randomized, Double-Blind, Placebo-Controlled Clinical Study
A newly published randomized, double-blind, placebo-controlled study demonstrates that ButyraGen delivers fast, clinically significant relief from belly pain and gas/bloating with especially strong benefits for women and post menopausal women, a group often underserved in gut health research. ButyraGen is a next-generation prebiotic complex featuring tributyrin and Sunfiber, designed to directly generate butyrate in the gut, independent of the microbiome.
The study was conducted virtually in a real-world setting with a starting population of 595 participants, evaluated ButyraGen’s effect on belly, pain, gas, and bloating, upper and lower gastrointestinal symptoms, digestive quality of life (DQLQ), as well as tolerability and safety. Participants received 200 mg daily of ButyraGen or placebo. The study was published on June 6 in Nutraceuticals.
The study demonstrates significant belly pain relief with the Intervention group showing an 18% greater improvement compared to placebo (p <0.01), and these benefits became statistically significant by weeks 5 to 6, highlighting cumulative affects overtime. Participants with mild reflux or constipation also experienced rapid improvement in DQLQ, within one to two weeks, with a 16.9% to 18.8% greater improvement versus placebo (p< 0.05). Notably, women benefited even more, achieving a 20.3% greater reduction in belly pain and a 14.9% decrease in gas and bloating compared to placebo, while post menopausal women experience the greatest benefit with a 26.4% greater improvement (p< 0.05). Importantly, ButyraGen was well tolerated, with mild side effects comparable to placebo and no serious adverse events reported.