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NCT05363618 · ClinicalTrials.gov registry record · NA
Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn
A NA study, sponsored by Microbiome Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 211
- Enrollment target
NCT05363618: Completed NA study, sponsored by Microbiome Health Sciences.
NCT05363618 is a NA study that has completed, run by Microbiome Health Sciences. The registered enrollment target is 211 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05363618, a NA study, has completed, sponsored by Microbiome Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 211 participants
- Enrollment target
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.
Primary Outcome
Tolerability is defined as the proportion of subjects at day 56 with number of days reporting heartburn no greater than baseline. The number of "heartburn days" is defined as the number of days where an answer of \>0 (ie, Not "0 - Did not have") is recorded for any of the RESQ-eD questions: "burning feeling behind your breastbone", "pain behind your breastbone", and "heartburn". Subjects who are missing at day 56 will be considered to have not tolerated the study product or to have not tolerated
Interventions
- DIETARY_SUPPLEMENT Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml)
- OTHER Placebo 1.4 ml
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2022-02-10 |
| Est. Completion | 2023-05-30 |
| Phase | NA |
What the finished NCT05363618 record still lists
NCT05363618 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) is the first listed.
NCT05363618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05363618 about?
NCT05363618 is a clinical study titled "Tolerability Study of Panosyl-Isomaltooligosaccharides (PIMO) and a Placebo in Subjects With Heartburn". 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 an...
What is the current status of trial NCT05363618?
This trial is currently completed. It is a NA study. The enrollment target is 211 participants. The study started on 2022-02-10. Estimated completion is 2023-05-30.
What interventions are being tested in trial NCT05363618?
The interventions under investigation include: Panosyl-isomaltooligosaccharides (PIMO) 1g (1.4 ml) (DIETARY_SUPPLEMENT), Placebo 1.4 ml (OTHER).
Who is sponsoring clinical trial NCT05363618?
This trial is sponsored by Microbiome Health Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05363618's enrollment target sits among peer trials
211 490th of 2000 higher than 1,511 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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