NCT07816809 · Colorado State University
Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience
(Phage-CLEAR)
What this study is about
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 effectiveness of two different bacteriophage-based treatments for 4 weeks to improve gut and skin health.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Bacteriophages - MuniPhage
1 x 106 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95
DIETARY_SUPPLEMENT
Bacteriophages - RenuPhage
1 x 106 PFU of phage strains LG91, BD117, CD007, and PD23
OTHER
Placebo
Rice maltodextrin
Primary outcome measures
Gastrointestinal Symptom Rating Scale
Time frame: 4 weeks
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"
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Between 18-75 years old
- 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
- 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
Where
- Fort Collins, Colorado
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2026 · Source of record for eligibility and locations