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NCT04677634 · ClinicalTrials.gov registry record · NA
Open Label Tolerability Study of ISOThrive Prebiotic Nectar (MIMO) in Subjects With Constipation
A NA study of Constipation, sponsored by ISOThrive.
- Completed
- Registry status
- NA
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT04677634: Completed NA study of Constipation, sponsored by ISOThrive.
NCT04677634 is a NA study of Constipation that has completed, run by ISOThrive. The registered enrollment target is 106 participants, below the 203-participant average among 54 other Constipation trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04677634, a NA study of Constipation, has completed, sponsored by ISOThrive.
- COMPLETED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose and efficacy endpoint of this study is to assess whether subjects with constipation predominant irritable bowel syndrome (IBS-C) or chronic Idiopathic constipation (CIC) tolerate ISOThrive.
Primary Outcome
PAC-QOL a validated questionnaire which measures subject experience over the prior 2 weeks, includes a total of 28 items in 4 subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life. This study will assess whether subjects with constipation tolerate ISOThrive by measuring the differences in baseline and post-intervention
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT ISOThrive Prebiotic Nectar
Study Locations (1)
Virginia
- ISOThrive Inc. - Manassas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2021-04-02 |
| Phase | NA |
What the finished NCT04677634 record still lists
NCT04677634 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 203-participant average among 54 other Constipation trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Constipation appearing as the primary indexed condition, and to 1 intervention - of which ISOThrive Prebiotic Nectar is the first listed.
NCT04677634 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04677634 about?
NCT04677634 is a clinical study titled "Open Label Tolerability Study of ISOThrive Prebiotic Nectar (MIMO) in Subjects With Constipation". The purpose and efficacy endpoint of this study is to assess whether subjects with constipation predominant irritable bowel syndrome (IBS-C) or chronic Idiopathic constipation (CIC) tolerate ISOThrive.
What is the current status of trial NCT04677634?
This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2020-10-14. Estimated completion is 2021-04-02.
What conditions does trial NCT04677634 study?
This clinical trial studies the following conditions: Constipation.
What interventions are being tested in trial NCT04677634?
The interventions under investigation include: ISOThrive Prebiotic Nectar (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04677634?
This trial is sponsored by ISOThrive, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04677634 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
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04677634's enrollment target sits among peer trials
106 15th of 54 higher than 40 of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation 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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