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NCT05129618 · ClinicalTrials.gov registry record · NA
Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)
A NA study, sponsored by Microbiome Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 172
- Enrollment target
NCT05129618: Completed NA study, sponsored by Microbiome Health Sciences.
NCT05129618 is a NA study that has completed, run by Microbiome Health Sciences. The registered enrollment target is 172 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05129618, a NA study, has completed, sponsored by Microbiome Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 172 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo controlled trial to evaluate the tolerability of MHS 1031. Tolerability will be assessed using the change in complete spontaneous bowel movements (CSBM), PRO questionnaires, concomitant medication assessments, and assessment of adverse events, from baseline (determined during Screening Phase) to Week 8 (Day 56). The primary analysis will be conducted to assess the tolerability of MHS 1031 product and of the formulated placebo in randomized subjects with CIC diagnosed according to a modified Rome IV criteria.
Primary Outcome
A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. Tolerability is defined as no overall worsening of constipation measurement scores after 8 weeks of taking the product or the placebo compared to baseline scores. More complete spontaneous bowel movements is better, fewer is worse.
Interventions
- OTHER placebo
- DIETARY_SUPPLEMENT MHS 1031
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2021-09-23 |
| Est. Completion | 2022-06-12 |
| Phase | NA |
What the finished NCT05129618 record still lists
NCT05129618 is an interventional study that assigns participants to a tested intervention. The registered 172 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 (88% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05129618 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05129618 about?
NCT05129618 is a clinical study titled "Tolerability Study of Panosyl Isomaltooligosaccharides (PIMO), in Subjects With Chronic Idiopathic Constipation (CIC)". This is a randomized, double blind, placebo controlled trial to evaluate the tolerability of MHS 1031. Tolerability will be assessed using the change in complete spontaneous bowel movements (CSBM), PRO questionnaires, concomitant medication assessments, and assessment of adverse events, from baselin...
What is the current status of trial NCT05129618?
This trial is currently completed. It is a NA study. The enrollment target is 172 participants. The study started on 2021-09-23. Estimated completion is 2022-06-12.
What interventions are being tested in trial NCT05129618?
The interventions under investigation include: placebo (OTHER), MHS 1031 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05129618?
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 NCT05129618's enrollment target sits among peer trials
172 612th of 2000 higher than 1,389 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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