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Purpose

Bacteriophages are viruses that can selectively infect specific species and strains of bacteria. Some bacterial species in the human gut have been negatively associated with gut health and skin health. This study is designed to measure the efficacy of two different bacteriophage-based treatments for 4 weeks to improve gut and skin health. These treatments are bacteriophage that target specific strains of Escherichia coli and Staphylococcus Aureus.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Between 18-75 years old - BMI <30 - Experiencing mild-moderate gastrointestinal distress/ abdominal pain, bloating, constipation, and/or diarrhea

Exclusion Criteria

  • Younger than 18 years old or greater than 75 years old - BMI >29.9 - Antibiotic use in the past 2 months - Use of statins, metformin, prescription NSAIDs, and MAO inhibitors, or other medications that could interfere with study outcomes, as determined by the study PI - Current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, or cardiometabolic disease (diabetes, cardiovascular disease) - Individuals with allergies to capsule ingredients - Pregnant or breastfeeding individuals - Excess alcohol consumption (≥4 drinks on any given occasion and/or ≥8 drinks/week for women, and ≥5 drinks on any given occasion and/or ≥15 drinks/week for men) - Use of dietary supplements that contain probiotics or phages - Actively trying to lose weight - Participation in other research studies that would interfere with study endpoints or compliance - Unable or unwilling to consume capsules, provide stool or blood samples, track bowel movements and symptoms, and attend scheduled clinic visits

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MuniPhage 		1 x 10E6 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95 that have been designed to target specific pro-inflammatory E. coli strains in the gut.
  • Dietary Supplement: Bacteriophages - MuniPhage
    1 x 106 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95
    Other names:
    • MuniPhage
Experimental
RenuPhage 		Dietary supplement containing 1 x 10E6 PFU of phage strains LG91, BD117, CD007, and PD23 designed to target S. aureus in the gut which may also reduce S. aureus load on the skin.
  • Dietary Supplement: Bacteriophages - RenuPhage
    1 x 106 PFU of phage strains LG91, BD117, CD007, and PD23
    Other names:
    • RenuPhage
Placebo Comparator
Placebo 		Rice maltodextrin
  • Other: Placebo
    Rice maltodextrin

Recruiting Locations

Colorado State University
Fort Collins, Colorado 80523
Contact:
Tiffany Weir, PhD
970-215-7571
tiffany.weir@colostate.edu

More Details

Status
Recruiting
Sponsor
Colorado State University

Study Contact

Tiffany Weir, PhD
970-215-7571
tiffany.weir@colostate.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.