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NCT04511221 · ClinicalTrials.gov registry record · NA
BacterioPHAGE for Gastrointestinal Health 2 Study
A NA study of Mild Gastrointestinal Symptoms in Healthy Adults, sponsored by Colorado State University.
- Completed
- Registry status
- NA
- Development phase
- 93
- Enrollment target
- 1
- Study location
NCT04511221: Completed NA study of Mild Gastrointestinal Symptoms in Healthy Adults, sponsored by Colorado State University.
NCT04511221 is a NA study of Mild Gastrointestinal Symptoms in Healthy Adults that has completed, run by Colorado State University. The registered enrollment target is 93 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04511221, a NA study of Mild Gastrointestinal Symptoms in Healthy Adults, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 93 participants
- Enrollment target
- 1
- Study location
Study Summary
The BacterioPHAGE for Gastrointestinal Health-2 study is designed to determine if a commercial bacteriophage product can increase the survival and efficacy of probiotic bacteria that will be concurrently administered. Bacteriophages may act as prebiotics, which are traditionally defined as indigestible dietary components that selectively enhance specific bacterial species in the intestines to confer a health benefit. In this study, the "prebiotic" is a unique combination of bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe for human consumption and are presumed to function by infecting pro-inflammatory E. coli strains in the gut. The removal of these strains alters the gut environment to allow growth of more favorable bacteria, and the lysis products of these E. coli may be assimilated by beneficial species to enhance their populations.The phage product, PreforPro, has shown to be effective in culture-based and animal studies, but its efficacy in increasing specific probiotic species has not been demonstrated in humans. The investigators have previously shown that PreforPro is both safe and tolerable in a human population and does not broadly disrupt the gut microbiota as would be seen with antibiotic treatment.
Primary Outcome
A functional gastrointestinal questionnaire was used to assess pain and symptoms related to GI function, GI inflammation, Colon and small intestine pain
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Bifidobacterium animals subsp. lactis BL04+PreforPro
- DIETARY_SUPPLEMENT Bifidobacterium animals subsp. lactis BL04
Study Locations (1)
Colorado
- Colorado State University - Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2020-03-31 |
| Phase | NA |
What the finished NCT04511221 record still lists
NCT04511221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Mild Gastrointestinal Symptoms in Healthy Adults appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04511221 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04511221 about?
NCT04511221 is a clinical study titled "BacterioPHAGE for Gastrointestinal Health 2 Study". The BacterioPHAGE for Gastrointestinal Health-2 study is designed to determine if a commercial bacteriophage product can increase the survival and efficacy of probiotic bacteria that will be concurrently administered. Bacteriophages may act as prebiotics, which are traditionally defined as indigesti...
What is the current status of trial NCT04511221?
This trial is currently completed. It is a NA study. The enrollment target is 93 participants. The study started on 2018-10-01. Estimated completion is 2020-03-31.
What conditions does trial NCT04511221 study?
This clinical trial studies the following conditions: Mild Gastrointestinal Symptoms in Healthy Adults.
What interventions are being tested in trial NCT04511221?
The interventions under investigation include: Placebo (OTHER), Bifidobacterium animals subsp. lactis BL04+PreforPro (DIETARY_SUPPLEMENT), Bifidobacterium animals subsp. lactis BL04 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04511221?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04511221 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04511221's enrollment target sits among peer trials
93 937th of 2000 higher than 1,064 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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