Recruiting

Bacteriophage Treatments

Sponsor:

Colorado State University

Code:

NCT07816809

Conditions

Gastrointestinal Symptoms

Skin Quality

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Bacteriophages - MuniPhage

Bacteriophages - RenuPhage

Placebo

Study Details

Brief summary:

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

Gastrointestinal Symptoms

Skin Quality

Study ID

NCT07816809

Start date

Sep 14, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

placebo comparator: Placebo

Rice maltodextrin

Interventions

Bacteriophages - MuniPhage

1 x 106 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95

Bacteriophages - RenuPhage

1 x 106 PFU of phage strains LG91, BD117, CD007, and PD23

Placebo

Rice maltodextrin

Primary outcome measure

  • Gastrointestinal Symptom Rating Scale [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Tiffany Weir, PhD

970-215-7571tiffany.weir@colostate.edu

Jenny Whittington, MS

970-310-6843ijwhitt@rams.colostate.edu

Locations

Colorado State University

Recruiting

Fort Collins, Colorado, United States, 80523

Contacts

Tiffany Weir, PhD

970-215-7571tiffany.weir@colostate.edu

Principal Investigator:

Tiffany Weir, PhD

More Information

Sponsor

Colorado State University

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • Gut Health
  • Skin Health
  • Bacteriophage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Colorado State University on 2026-09-14.