Efficacy and Safety of a Novel Therapeutic of Natural Origin (NTN) in Adult Patients with Lactose Intolerance: A Multicenter, Randomized, Crossover, Double-Blind, Placebo-Controlled Study.

Abstract

Background: Film-forming substances, such as natural polysaccharides (NP) and pea proteins (PP), act as a protective barrier for treating various gastrointestinal conditions. We assessed the efficacy and safety of a novel therapeutic of natural origin (NTN) containing NP and PP for symptomatic treatment of lactose intolerance. Methods: In this multicenter, randomized, double-blind, parallel-group study, patients with lactose intolerance received NTN (n = 30) or placebo (n = 30) for 7 days, then the alternate treatment for 7 days. Patients rated their gastrointestinal symptoms using a 7-point Likert scale. The lactose hydrogen breath test was used to assess exhaled hydrogen. Results: NTN as primary or crossover treatment significantly improved patient-reported symptoms of bloating, distension, and abdominal pain. Abdominal pain also improved under primary treatment with placebo. Primary treatment with NTN, but not placebo, normalized mean exhaled hydrogen levels. In the group allocated initially to placebo, crossover to NTN attenuated the increase in hydrogen production. No treatment-related adverse effects were reported in either group. Conclusions: Subjective improvements in bloating, distension, and abdominal pain with NTN were supported by objective evidence of hydrogen production normalization. NTN appears to be a useful alternative to lactose avoidance or enzyme replacement in patients with lactose intolerance.