Gastrointestinal Symptoms, Skin Quality
Conditions
Keywords
Gut Health, Skin Health, Bacteriophage
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.
Interventions
DIETARY_SUPPLEMENTBacteriophages - MuniPhage
1 x 106 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95
DIETARY_SUPPLEMENTBacteriophages - RenuPhage
1 x 106 PFU of phage strains LG91, BD117, CD007, and PD23
OTHERPlacebo
Rice maltodextrin
Sponsors
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18-75 years old * BMI \<30 * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | 4 weeks | The gastrointestinal symptom rating scale is a widely used tool for measuring gastrointestinal symptoms across five domains. |
Countries
United States
Contacts
CONTACTTiffany Weir, PhD
CONTACTJenny Whittington, MS
PRINCIPAL_INVESTIGATORTiffany Weir, PhD
Colorado State University
Outcome results
None listed