Clinical study
PHAGE2
BacterioPHAGE for Gastrointestinal Health 2 Study
| Status | Completed |
|---|---|
| Type | Adjacent product trial |
| Countries | United States |
| Conditions studied | Mild Gastrointestinal Symptoms in Healthy Adults |
| Study years | 2018–2020 |
| Entry review | 2026-10-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
Inclusion Criteria: * healthy * 18-65 years old * BMI 20 to 34.9 Exclusion Criteria: * individuals less than 18 years of age or greater than 65 years of age * outside of the BMI range of 20-34.9 * antibiotic or probiotic/prebiotic supplements within two months of the start of treatment * use of statins, metformin, NSAIDs, MAO inhibitors, and botanical supplements that target the GI tract or gut microbiota * current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and metabolic disorders * pregnant and breastfeeding women * unable to adhere to the study requirements
Study description
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.
Study registrations
| ClinicalTrials.gov | NCT04511221 |
|---|
Recorded study locations (1)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
Colorado State University
Fort Collins, Colorado, United States
Recorded site status: Not separately listed. Study location source ↗
Sources and updates
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| Study ID | nct04511221 |
|---|