Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience (Phage-CLEAR)

September 8, 2026 updated by: Tiffany Weir, Colorado State University

Phage-CLEAR: Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523
        • Recruiting
        • Colorado State University
        • Principal Investigator:
          • Tiffany Weir, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal Symptom Rating Scale
Time Frame: 4 weeks
The gastrointestinal symptom rating scale is a widely used tool for measuring gastrointestinal symptoms across five domains.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Investigators

  • Principal Investigator: Tiffany Weir, PhD, Colorado State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 14, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7927

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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