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Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease

NCT04491734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-08-30

No results posted yet for this study

Summary

This is a remote study. No office visits required. The purpose and efficacy endpoint of this study is to assess whether GERD patients tolerate ISOT-101. In addition, usage of the ReQuest validated questionnaire to measure GERD symptoms will be explored as well as usage of the validated SF-36 quality of life (QoL) questionnaire. Each subject serves as his/her own control. Relative tolerability in subjects both on and off proton pump inhibitors (PPIs) will be compared. Subjects naive to PPIs, currently taking PPIs and historically on PPIs will be evaluated with ReQuest and QoL scores. In addition, survey measurements will be taken on a subset of 10 subjects that are non-responders to PPIs. These will not be included in the statistical analysis with the above groups. A tertiary endpoint of this study is to assess any relevant adverse events that occur.

Conditions

  • Gastroesophageal Reflux

Interventions

DIETARY_SUPPLEMENT

maltosyl-isomalto-oligosaccharides (MIMO)

Digestion-resistant carbohydrate, ISOT-101, a specific formulation of maltosyl-isomalto-oligosaccharides (MIMO), that serves as a prebiotic, feeding selected bacteria that commonly inhabit the human GI tract.

Sponsors & Collaborators

  • ISOThrive Inc.

    lead INDUSTRY

Principal Investigators

  • John Selling, MD · ISOThrive Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-08-26
Completion
2021-08-26

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 NCT04491734 on ClinicalTrials.gov