Phage-based Control and Limitation of Pathobionts for Microbiome Equilibrium and Resilience
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorColorado State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Between 18-75 years old
BMI <30
Experiencing mild-moderate gastrointestinal distress/ abdominal pain, bloating, constipation, and/or diarrhea
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
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
Other interventionRice maltodextrin
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: MuniPhageExperimental treatment 1 intervention
Group B: RenuPhageExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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 weeksSponsors and contacts
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Source ClinicalTrials.gov