Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04511221
The ClinicalTrials.gov registry entry for NCT04511221 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 93 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.