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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 is a NA study that has completed, run by Colorado State University. The registered enrollment target is 120 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05750433
The ClinicalTrials.gov registry entry for NCT05750433 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Colorado State University, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05750433 reports 0 study locations.
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.
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