BacterioPHAGE for Gastrointestinal Health 2 Study

Completed · Not applicable · Has a placebo group

Conditions studied: Mild Gastrointestinal Symptoms in Healthy Adults

In brief

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.

Key facts

Study ID

NCT04511221

Run by

Colorado State University

People needed

93

Starts

2018-10-01

Expected to finish

2020-03-31

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy
• 18-65 years old
• BMI 20 to 34.9

You may not qualify if…

• 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

Where it is running

• Colorado State University — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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