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NCT04491734 · ClinicalTrials.gov registry record · NA
Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease
A NA study of Gastroesophageal Reflux, sponsored by ISOThrive.
- Completed
- Registry status
- NA
- Development phase
- 156
- Enrollment target
- 1
- Study location
NCT04491734: Completed NA study of Gastroesophageal Reflux, sponsored by ISOThrive.
NCT04491734 is a NA study of Gastroesophageal Reflux that has completed, run by ISOThrive. The registered enrollment target is 156 participants, below the 2,881-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04491734, a NA study of Gastroesophageal Reflux, has completed, sponsored by ISOThrive.
- COMPLETED
- Registry status
- NA
- Development phase
- 156 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Assess whether symptomatic GERD patients tolerate ISOT-101 by measuring the differences in baseline and post-intervention score using GERD ReQuest Short Version. The scores for weeks 1, 2, 3, and 4 will be compared with baseline. With regard to the ReQuest Short Version questionnaire, the range is 0 to 46.28 with higher numbers reflecting more severe symptoms. Tolerability is defined as the post-intervention score is equal to or less than baseline.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT maltosyl-isomalto-oligosaccharides (MIMO)
Study Locations (1)
Virginia
- ISOThrive Inc. - Manassas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2021-08-26 |
| Phase | NA |
What the finished NCT04491734 record still lists
NCT04491734 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 2,881-participant average among 33 other Gastroesophageal Reflux trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Gastroesophageal Reflux appearing as the primary indexed condition, and to 1 intervention - of which maltosyl-isomalto-oligosaccharides (MIMO) is the first listed.
NCT04491734 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04491734 about?
NCT04491734 is a clinical study titled "Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease". 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...
What is the current status of trial NCT04491734?
This trial is currently completed. It is a NA study. The enrollment target is 156 participants. The study started on 2020-06-01. Estimated completion is 2021-08-26.
What conditions does trial NCT04491734 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux.
What interventions are being tested in trial NCT04491734?
The interventions under investigation include: maltosyl-isomalto-oligosaccharides (MIMO) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04491734?
This trial is sponsored by ISOThrive, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04491734 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04491734's enrollment target sits among peer trials
156 12th of 33 higher than 22 of 33 other Gastroesophageal Reflux trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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