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Dietary Supplement

Product Tolerability Arm for Heartburn

N/A

Waitlist Available

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 8 weeks

Awards & highlights

Study Summary

This trial is to see if a new medication, MHS-1031, is safe and tolerable for people with heartburn. 400 people will be given either the medication or a placebo, and will be monitored for side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, 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

Tolerability as recorded via RESQ-eD (online PRO) questions

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Product Tolerability ArmActive Control1 Intervention

Study Product MHS-1031 1g (1.4 ml) per day

Group II: Placebo Tolerability ArmPlacebo Group1 Intervention

Placebo (Neotame 7.92 mcg/g, phosphoric acid, and sterile water) 1.4 ml per day

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Microbiome Health SciencesLead Sponsor

2 Previous Clinical Trials

328 Total Patients Enrolled

Peter Swann, MDPrincipal InvestigatorMicrobiome Health Sciences

2 Previous Clinical Trials

328 Total Patients Enrolled

Frequently Asked Questions

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

Who is eligible to join the research initiative?

"This clinical trial is open to 400 participants aged 18-75 who suffer from heartburn. In order for them to be eligible, they must also meet the following conditions: employ adequate contraception methods if of childbearing potential; consent and commit to all protocol activities; have basic English proficiency plus the ability to use a computer or smart device with internet access daily throughout the study period; maintain stable doses of chronic medication (no more than 40mg/day of omeprazole); and females both surgically sterilized or postmenopausal as well as males are welcome to apply."

Answered by AI

Are there any vacancies remaining for participants in this clinical experiment?

"Still open for enrolment, the clinical trial was first announced on February 10th 2022 and has since been revised as of May 3rd."

Answered by AI

Is the minimum age requirement for this research 18 years or older?

"This research is seeking participants aged between 18-75."

Answered by AI

What is the sample population of this research project?

"Affirmative. As evidenced on clinicaltrials.gov, this ongoing medical trial is recruiting 400 participants from a single site. The initial post was published in February 10th 2022 and the information has been recently updated on May 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn

2022. "Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363618.