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BacterioPHAGE for Gastrointestinal Health 2 Study

NCT04511221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2020-08-13

No results posted yet for this 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

  • Mild Gastrointestinal Symptoms in Healthy Adults

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium animals subsp. lactis BL04+PreforPro

One 15mg capsule taken orally each day

DIETARY_SUPPLEMENT

Bifidobacterium animals subsp. lactis BL04

One 15mg capsule taken orally each day

OTHER

Placebo

One 15mg capsule taken orally each day

Sponsors & Collaborators

  • Colorado State University

    lead OTHER

Principal Investigators

  • Tiffany L Weir, PhD · Colorado State University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-10-31
Completion
2020-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511221 on ClinicalTrials.gov