MHS-1031 is a specific proprietary digestion-resistant oligosaccharide carbohydrate that serves as a prebiotic. The active ingredient in MHS-1031 is a well-defined and well-characterized distribution of panosyl-isomaltooligosaccharides (PIMOs) ranging in degree of polymerization (DP) from DP3 to DP8.~All candidate subjects must be at least partial responders to daily proton pump inhibitor (PPI) acid suppressive therapy. Candidate subjects will be screened for medical history of chronic heartburn that may be associated with other medical conditions, and these subjects will be excluded.~Two groups will be studied: those responsive to proton pump inhibitors (PPI-R) and those partially responsive to proton pump inhibitors (PPI- PR). Subjects will undergo a baseline screening phase of two weeks (PPI-PR and PPI-R) (Screening Phase [SP]) followed by eight weeks of treatment with MHS-1031 (1 g/day) or placebo (Treatment Phase [TP]).~The primary objective of this study is to evaluate the effect of daily MHS-1031 administration adjunctive to PPI therapy on change in heartburn symptom-free days in PPI Responders and PPI-Partial Responders.~Efficacy will be assessed using patient reported outcome (PRO) questionnaires, concomitant medication assessments, and assessment of adverse events, from baseline (determined during Screening Phase 2- Week Assessment) to Treatment Phase Week 8 (taking daily MHS-1031, or placebo, alone, no PPI) [PPI-PR] and Treatment Phase Week 8 (taking daily MHS-1031, or placebo, alone, no PPI) [PPI-R]. The primary analysis will be conducted to assess the efficacy of MHS-1031 adjunctive to PPI therapy in two similar groups of randomized subjects with GERD-related heartburn as determined by the RESQ-eD validated questionnaire, validated for use online.~For this study, heartburn-free days are defined as subject report of 'Did Not Have', 'Very Mild' or 'Mild' on each of the first three questions presented on the nightly RESQ-eD.
This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the effect of MHS-1031 on heartburn symptom-free days in two similar subject groups with GERD-related heartburn symptoms.