Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD

MHS‐1031 is a specific proprietary digestion‐resistant oligosaccharide carbohydrate thatserves as a prebiotic. The active ingredient in MHS‐ 1031 is a well‐defined andwell‐characterized distribution of panosyl‐isomaltooligosaccharides (PIMOs) ranging indegree of polymerization (DP) from DP3 to DP8.This study will be conducted as a multi‐center, randomized, double‐blind,placebo‐controlled trial to evaluate the effect of MHS‐1031 adjunctive to PPI therapy onheartburn‐free days in subjects with GERD‐related heartburn symptoms who self‐reportimprovement while on sustained daily PPI therapy. Heartburn‐free days will be determinedby subject report specific to any of the three questions ("burning feeling behind thebreastbone" and/or "pain behind your breastbone" and/or "heartburn"; Questions 1, 2 & 3of the RESQ‐eD). For purposes of this trial, heartburn‐free days are defined as subjectreport of 'Did Not Have', or 'Very Mild' on each of the three RESQ‐eD questions listedabove.All candidate subjects must self‐report at least partial response to sustained daily PPIacid suppressive therapy (i.e. 'daily' defined as taking PPIs 5‐7 days/week on average).Candidate subjects will be screened for medical history of chronic heartburn that may beassociated with other medical conditions, and these subjects will be excluded. The entirestudy consists of three phases: Remote Screening Phase 2‐Week Assessment (SP1), on‐siteScreening Phase Part 2 (SP2) and Treatment Phase (TP).Efficacy will be assessed using patient reported outcome (PRO) questionnaires,concomitant medication assessments, and assessment of adverse events, from baseline(determined during Remote Screening Phase 2‐Week Assessment) to Treatment Phase Weeks 1‐4and Weeks 5‐8. The primary analyses will be conducted to assess the efficacy of MHS‐1031adjunctive to PPI therapy, and separately as monotherapy subsequent to combined PPI andMHS‐1031 therapy, in randomized subjects with GERD‐related heartburn as determined by theRESQ‐eD validated questionnaire, validated for use online.