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MHS-1031 for Acid Reflux

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 8 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heartburn-free days/week
Secondary outcome measures
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
Acid Reflux Research Study Groups: Drug Product, Placebo
Acid Reflux 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age eligibility for this clinical investigation limited to individuals over 25 years old?

"To be eligible for this medical trial, patients must range between 18 to 75 years of age. Separately there are 13 trials available for minors and 60 additional studies catered towards elderly individuals."

Answered by AI

Is the enrollment phase of this experiment still ongoing?

"Data hosted on clinicaltrials.gov indicates that this research endeavour, which was initially published on March 3rd 2023, is not actively recruiting right now. Although recruitment has been suspended for now, 73 other studies are seeking participants as of present."

Answered by AI

Has the Proton Pump Inhibitor (PPI) Responders - Drug Product received authorization from the FDA?

"Our team at Power judged Proton Pump Inhibitor (PPI) Responders - Drug Product as a 2 on the safety scale, due to Phase 2 clinical trial data that suggests some degree of assurance in its security but lack of evidence for efficacy."

Answered by AI

Could I possibly qualify for participating in this medical trial?

"This medical trial is recruiting 231 individuals aged 18-75 that are suffering from acid reflux. In order to be eligible, participants must meet the following criteria: ability to comprehend and consent; access to online questionnaires daily; a BMI between 19 and 35 kg/m2.; postmenopausal or surgically sterile female candidates must use medically accepted contraception during study duration; stable doses of chronic medications (except GERD); endoscopy results within 90 days prior to screening call confirm symptom improvement with PPI intake for 3+ days per week on average in the past three months; maintained dietary lifestyle for 30 days before screening call up until E"

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’ve been having trouble with my acid reflux and trouble swallowing that has marginally improved with PPI treatment.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD
2023. "Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05556824.
All > Gerd > Microbiome
~55 spots leftby Dec 2024
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