Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience
Part of paid clinical trials in Fort Collins, Colorado.
- Sponsor
- Colorado State University
- Study ID
- NCT07816809
- Status
- Recruiting
Conditions
- Gastrointestinal Symptoms
- Skin Quality
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Bacteriophages - MuniPhage — DIETARY_SUPPLEMENT1 x 106 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95
- Bacteriophages - RenuPhage — DIETARY_SUPPLEMENT1 x 106 PFU of phage strains LG91, BD117, CD007, and PD23
- Placebo — OTHERRice maltodextrin
Study Details
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.
Key Dates
- First listed
- Sep 14, 2026
- Start date
- Sep 14, 2026
- Status verified
- Sep 2026
- Primary completion
- Aug 31, 2027
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: MuniPhage1 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: RenuPhageDietary 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: PlaceboRice maltodextrin
Primary Outcome Measure
Gastrointestinal Symptom Rating Scale [ Time Frame: 4 weeks ]
Central Contacts
- Tiffany Weir, PhD970-215-7571
- Jenny Whittington, MS970-310-6843
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Colorado State University | Fort Collins | Colorado | 80523 | Tiffany Weir, PhD (PRINCIPAL_INVESTIGATOR) |
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