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MHS-1031 for Acid Reflux

Verified Trial
Phase 2
Recruiting
Led By Peter Swann, MD
Research Sponsored by Microbiome Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been diagnosed with Gastroesophageal Reflux Disease (GERD)?
Have you experienced heartburn symptoms over the last 3 months?
Must not have
In the last year have you struggled with alcoholism or frequent tobacco or nicotine use?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 8 weeks

Summary

This trial will compare an experimental drug to a placebo to see if it helps reduce heartburn symptoms in people with GERD.

Who is the study for?
Adults aged 18-75 with a BMI of 19-35, experiencing GERD-related heartburn despite taking daily PPI medication, can join this trial. They must be able to complete online questionnaires in English and have had an endoscopy within the last 90 days. Women should use contraception if of childbearing potential. Exclusions include recent stroke or MI, GI abnormalities affecting motility, certain dietary supplements like FOS or inulin, rigorous weight loss programs, neuropsychiatric disorders, gastric surgery history except benign polyp removal.
What is being tested?
The study tests MHS-1031's effectiveness on increasing heartburn-free days for GERD patients compared to a placebo. Participants will be randomly assigned to either receive MHS-1031 or a placebo without knowing which one they're getting (double-blind). They'll continue their usual PPI therapy throughout the trial.
What are the potential side effects?
While specific side effects are not listed for MHS-1031 as it is under investigation, common side effects from similar gastrointestinal treatments may include digestive issues such as nausea or constipation and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 and 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heartburn-free days/week
Secondary study objectives
GERD-related severity satisfaction
Heartburn
Heartburn-free day satisfaction

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Drug ProductActive Control1 Intervention
Panosyl-isomaltooligosaccharide (PIMO) liquid 1 g (1.5 ml) per day for 8 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo liquid (1.5 ml) per day for 8 weeks

Find a Location

Who is running the clinical trial?

Microbiome Health SciencesLead Sponsor
2 Previous Clinical Trials
383 Total Patients Enrolled
VBHRC Virginia CatalystUNKNOWN
Peter Swann, MDPrincipal InvestigatorMicrobiome Health Sciences
2 Previous Clinical Trials
383 Total Patients Enrolled

Media Library

Drug Product Clinical Trial Eligibility Overview. Trial Name: NCT05556824 — Phase 2
Peptic Ulcer Research Study Groups: Drug Product, Placebo
Peptic Ulcer Clinical Trial 2023: Drug Product Highlights & Side Effects. Trial Name: NCT05556824 — Phase 2
Drug Product 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556824 — Phase 2
~19 spots leftby Apr 2025
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