NCT07816809

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Jan 2028

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 14, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

September 8, 2026

Last Update Submit

September 8, 2026

Conditions

Gastrointestinal SymptomsSkin Quality

Keywords

Gut HealthSkin HealthBacteriophage

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal Symptom Rating Scale

    The gastrointestinal symptom rating scale is a widely used tool for measuring gastrointestinal symptoms across five domains.

    4 weeks

Study Arms (3)

MuniPhage

EXPERIMENTAL

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

RenuPhage

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Rice maltodextrin

Other: Placebo

Interventions

Bacteriophages - MuniPhageDIETARY_SUPPLEMENT

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

Also known as: MuniPhage
MuniPhage
Bacteriophages - RenuPhageDIETARY_SUPPLEMENT

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

Also known as: RenuPhage
RenuPhage
PlaceboOTHER

Rice maltodextrin

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

Study Officials

  • Tiffany Weir, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Weir, PhD

CONTACT

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

Jenny Whittington, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start

September 14, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

September 14, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)