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

NCT05363618 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2023-07-18

No results posted yet for this study

Summary

Remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in subjects with heartburn. Candidates will have heartburn and be taking daily PPIs at up to twice the standard OTC or prescription dosage. Approximately 400 subjects (men and women of all races and ethnicities) will be randomly enrolled in a 1:1 ratio to receive Product or Placebo (1.4 ml) per day.

Conditions

  • Heartburn

Interventions

DIETARY_SUPPLEMENT

Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)

Active study product

OTHER

Placebo 1.4 ml

Placebo

Sponsors & Collaborators

  • Microbiome Health Sciences

    lead INDUSTRY

Principal Investigators

  • Peter Swann, MD · Microbiome Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-05-30
Completion
2023-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05363618 on ClinicalTrials.gov