PHAGE Study: Bacteriophages as Novel Prebiotics

The goal of this study is to see if consumption of PreforPro, a commercially available prebiotic dietary supplement consisting of a mixture of bacteriophages, improves gut bacteria profiles in individuals relative to a placebo control. Secondary outcome measures include determining changes in comprehensive metabolic profiles, inflammatory markers (systemic and local), microbial metabolites, and perceptions of gastrointestinal distress. To accomplish these research goals, 40 male and female volunteers between 18-65 years old with BMI scores of 20 to 34.9 who suffer from mild gastrointestinal distress will be enrolled.Recruitment will be by referral from local practitioners and through email solicitations. Eligibility will be determined at the Colorado State University Medical Nutrition Therapy Laboratory (MNTL) by a screening questionnaire and interview/assessment by the clinical coordinator. After determining eligibility and securing consent, participants will randomly be assigned to 1 of 2 treatment groups: prebiotic or placebo. Participants will consume one capsule daily of respective treatments for a period of four (4) weeks. At the beginning and end of the 4 week treatment periods blood and stool samples will be collected at the Human Performance Clinical Research Laboratory (HPCRL). This means that participants will make a total of four (4) clinic visits during each treatment period. Following the initial treatment period, all participants will be required to undergo a wash-out period for two (2) weeks. Upon completion of the wash-out period, participants will switch treatment groups for a period of four (4) weeks. Clinic visits at baseline and 4-weeks for collection of stool and blood samples will also be conducted during the second treatment period. Study participants will be required to provide a total of four (4) fecal samples and four (4) fasting blood samples. Additionally, study participants will be required to provide a weekly assessment of GI symptoms during the two treatment periods. All blood samples will be collected at Colorado State University by trained professionals. Fecal sample collection will be performed by the study participant with collection materials provided by study personnel. Both participants and researchers will be blinded during the course of the intervention and throughout the data analysis period. Blinding will be conducted by individuals from Deerland Enzymes, the company that is providing the capsules for intervention.

Inclusion criteria

• Healthy adults
• 18-65 years old
• Mild to moderate GI distress (self-assessed)

Exclusion criteria

• Pregnant or breastfeeding
• Diagnosed GI disease (Celiac, peptic ulcer, ulcerative colitis, Crohn's disease, cancer, or other gastrointestinal or metabolic diseases)
• Antibiotic use in the past 2 months
• Use of NSAIDS, statins, metformin, and other drugs known to modify the gut microbiota
• BMI less than 18.0 or greater than 35.0