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NCT05750433 · ClinicalTrials.gov registry record · NA
Phage 3Determination of Phage/Probiotic Synergistic Effects on Gastrointestinal Health
A NA study, sponsored by Colorado State University.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT05750433: Completed NA study, sponsored by Colorado State University.
NCT05750433 is a NA study that has completed, run by Colorado State University. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05750433, a NA study, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
The goal of this double blinded clinical trial is to determine whether consumption of the PreforPro product, when co-consumed with Bacillus subtilis DE111 probiotic, synergistically improves bowel regularity, perceived physical symptoms of gastrointestinal distress and other aspects of gastrointestinal health over probiotic use alone. Therefore, the primary goal of this study is to see if PreforPro consumption concurrent with B. subtilis DE111 usage improves probiotic activity. The secondary goal of this study is to assess non-gastrointestinal physiologic parameters to determine whether consumption of PreforPro combined with the probiotic offers any additional health benefits (ie. reduced inflammation, improved gut microbiota profiles) beyond those of consuming a probiotic alone. Participants will be asked to track daily bowel movements for 7 days prior to beginning capsule consumption and record their diet for a total 3 of days (two weekdays and one weekend day). They will then be asked to consume the provided capsules daily for a period of 45 days. Researchers will compare three parallel arms; (1) PreforPro+B. subtilis DE111 probiotic, (2) B. subtilis DE111 alone, or (3) a maltodextrin placebo to establish their impact on gastrointestinal symptoms and other indicators of health.
Primary Outcome
Self-assessment of functional measures of gastrointestinal health, including colon and small intestinal pain, gastric function, and gastrointestinal inflammation.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT PreforPro+B. subtilis DE111 probiotics
- DIETARY_SUPPLEMENT B. subtilis DE111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2024-03-31 |
| Phase | NA |
What the finished NCT05750433 record still lists
NCT05750433 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05750433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05750433 about?
NCT05750433 is a clinical study titled "Phage 3Determination of Phage/Probiotic Synergistic Effects on Gastrointestinal Health". The goal of this double blinded clinical trial is to determine whether consumption of the PreforPro product, when co-consumed with Bacillus subtilis DE111 probiotic, synergistically improves bowel regularity, perceived physical symptoms of gastrointestinal distress and other aspects of gastrointesti...
What is the current status of trial NCT05750433?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2021-10-01. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT05750433?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), PreforPro+B. subtilis DE111 probiotics (DIETARY_SUPPLEMENT), B. subtilis DE111 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05750433?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05750433's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 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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