NCT05556824

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

A Multi-Center Study of Panosyl-Isomaltooligosaccharides (PIMO) Adjunctive to Proton Pump Inhibitor (PPI) Therapy to Treat Gastroesophageal Reflux Disease (GERD) in Subjects Who Are PPI-Responders or PPI-Partial Responders

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (estimated)
• Sponsor: Microbiome Health Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the effect of MHS-1031 on heartburn-free days in subjects with GERD-related heartburn symptoms.

Detailed description

MHS-1031 is a specific proprietary digestion-resistant oligosaccharide carbohydrate that serves as a prebiotic. 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 on heartburn-free days in subjects with GERD-related heartburn symptoms who self-report improvement while on sustained daily PPI therapy. Heartburn-free days will be determined by subject report specific to any of the three questions ("burning feeling behind the breastbone" and/or "pain behind your breastbone" and/or "heartburn"; Questions 1, 2 \& 3 of the RESQ-eD). For purposes of this trial, heartburn-free days are defined as subject report of 'Did Not Have', or 'Very Mild' on each of the three RESQ-eD questions listed above. All candidate subjects must self-report at least partial response to sustained daily PPI acid 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 be associated with other medical conditions, and these subjects will be excluded. The entire study consists of three phases: Remote Screening Phase 2-Week Assessment (SP1), on-site Screening 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 1-4 and Weeks 5-8. The primary analyses will be conducted to assess the efficacy of MHS-1031 adjunctive to PPI therapy, and separately as monotherapy subsequent to combined PPI and MHS-1031 therapy, in randomized subjects with GERD-related heartburn as determined by the RESQ-eD validated questionnaire, validated for use online.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	MHS-1031	Study medication will be supplied as a syrup in individual sachets containing 1g (1.5 mL) of MHS-1031. Subjects will be randomized in 2:1 fashion to either study drug (2) or placebo (1)
OTHER	Placebo	Matching placebo is an oral solution formulated to have a degree of sweetness and acidity similar to the study medication and will be provided in equivalent sachets containing 1.5g (1.5 mL) of the oral placebo solution.

Timeline

• Start date: 2023-03-03
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-09-27
• Last updated: 2026-03-25

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study