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NCT05556824 · ClinicalTrials.gov registry record · Phase 2
Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD
A Phase 2 study of Gastroesophageal Reflux, sponsored by Microbiome Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 247
- Enrollment target
- 18
- Study locations
NCT05556824: Recruiting Phase 2 study of Gastroesophageal Reflux, sponsored by Microbiome Health Sciences.
NCT05556824 is a Phase 2 study of Gastroesophageal Reflux that is actively recruiting participants, run by Microbiome Health Sciences. The registered enrollment target is 247 participants, below the 2,879-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (91% lower). The trial reports 18 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05556824, a Phase 2 study of Gastroesophageal Reflux, is actively recruiting participants, sponsored by Microbiome Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 247 participants
- Enrollment target
- 18
- Study locations
Study 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.
Primary Outcome
The difference between baseline weekly average heartburn-free days and weekly average heartburn-free days during Treatment Phase Weeks 1-4 and Weeks 5-8 (as measured using questions 1, 2 and 3 of the Reflux Symptom Questionnaire Electronic Diary) (RESQ-eD).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG MHS-1031
Study Locations (18)
Florida
- Wr-Msra, Llc - Lake City
- A Positive Clinical Research - Miami
- Advanced Gastroenterology Associates LLC - Palm Harbor
- Health Synergy Clinical Research - West Palm Beach
- West Palm Quality Research (WPQR) - West Palm Beach
Virginia
- University of Virginia Health System - Charlottesville
- Charlottesville Medical Research Center - Charlottesville
- Digestive Disease and Liver Specialists - Norfolk
- GI Research Partners, LLC - Richmond
Georgia
- EmVenio-Georgia (EMGA) - Atlanta
- WR-Mount Vernon Clinical Research (MVCR) - Sandy Springs
Texas
- SMS Clinical Research (SMSR) - Mesquite
- A and U Family Medicine (NCR) - Sugar Land
Arizona
- Elite Clinical Studies LLC - Phoenix
California
- Angel City Research - Los Angeles
Michigan
- Gastroenterology Associates of Western Michigan PLC (WMCR) - Wyoming
North Carolina
- M3 Wake Research (CPOR) - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
What NCT05556824 shows while recruiting
NCT05556824 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, below the 2,879-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05556824 lists 18 locations in 9 states (Florida, Virginia, Georgia).
Frequently Asked Questions
What is clinical trial NCT05556824 about?
NCT05556824 is a clinical study titled "Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD". 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.
What is the current status of trial NCT05556824?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2023-03-03. Estimated completion is 2026-03.
What conditions does trial NCT05556824 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux.
What interventions are being tested in trial NCT05556824?
The interventions under investigation include: Placebo (OTHER), MHS-1031 (DRUG).
Who is sponsoring clinical trial NCT05556824?
This trial is sponsored by Microbiome Health Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05556824 being conducted?
This trial has 18 study locations across Arizona, California, Florida, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastroesophageal Reflux
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05556824's enrollment target sits among peer trials
247 9th of 33 higher than 25 of 33 other Gastroesophageal Reflux trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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