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PHAGE Study: Bacteriophages as Novel Prebiotics

NCT03269617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-04-04

No results posted yet for this study

Summary

The PHAGE study is designed to determine if a commercial prebiotic product can change the composition of bacteria in the gut for improved intestinal health. A prebiotic is defined as an indigestible dietary component that selectively enhances specific bacterial species in the intestines to confer a health benefit. In this study, the prebiotic a unique combination of bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe for human consumption and work by infecting bad bacteria in the gut, which allows beneficial bacteria populations to increase. The product, PreforPro, has shown to be effective in culture-based and animal studies, but its efficacy has not been demonstrated in humans. The goal of this study is to see if PreforPro consumption improves gut bacteria profiles in individuals relative to a placebo control and is associated with reduced incidence and severity of gastrointestinal distress.

Conditions

  • Gastrointestinal Disorder, Functional

Interventions

DIETARY_SUPPLEMENT

Bacteriophage mixture

Four bacteriophage strains: LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae.

OTHER

Placebo Control

Placebo control capsule consisting of rice maltodextrin

Sponsors & Collaborators

  • George Mason University

    collaborator OTHER

  • Metabiomics Corp

    collaborator INDUSTRY

  • Colorado State University

    lead OTHER

Principal Investigators

  • Tiffany Weir, PhD · Colorado State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2017-05-30
Completion
2017-05-30

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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 NCT03269617 on ClinicalTrials.gov