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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 is a NA study that has completed, run by Microbiome Health Sciences. The registered enrollment target is 172 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05129618
The ClinicalTrials.gov registry entry for NCT05129618 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Microbiome Health Sciences, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05129618 reports 0 study locations.
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.
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