ClinicalTrials.gg
RecruitingNCT07816809Phage-CLEARUpdated Oct 8, 2026

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

An interventional study of Bacteriophages - MuniPhage and Bacteriophages - RenuPhage in Gastrointestinal Symptoms and Skin Quality, sponsored by Colorado State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Colorado State University · Not applicable, Interventional, and Supportive care

Updated Oct 8, 2026Primary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastrointestinal Symptoms
  • Skin Quality

Keywords

  • Gut Health
  • Skin Health
  • Bacteriophage
03

In context

Lead sponsor

Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Younger than 18 years old or greater than 75 years old
  • >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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study 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.

    Dietary Supplement: Bacteriophages - 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

  • Placebo comparator
    Placebo

    Rice maltodextrin

    Other: Placebo

Interventions

  • Dietary supplementBacteriophages - MuniPhage

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

    Also known as: MuniPhage

  • Dietary supplementBacteriophages - RenuPhage

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

    Also known as: RenuPhage

  • OtherPlacebo

    Rice maltodextrin

06

What researchers measure

Primary outcomes

  1. Gastrointestinal Symptom Rating Scale

    The Gastrointestinal Symptom Rating Scale (GSRS) is a widely used tool for measuring gastrointestinal symptoms across five domains. The GSRS is scored between "No discomfort" and "Very severe discomfort"

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionGastrointestinal Symptom Rating Scale: how it is measured was reworded
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionGastrointestinal Symptom Rating Scale: how it is measured was reworded
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07816809
Responsible party
Tiffany Weir (Professor, Colorado State University) — Principal investigator
First posted
Sep 14, 2026
Start date
Sep 14, 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Tiffany Weir, PhD
Contact
tiffany.weir@colostate.edu
970-215-7571
Jenny Whittington, MS
Contact
ijwhitt@rams.colostate.edu
970-310-6843
Tiffany Weir, PhD
principal investigator · Colorado State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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