PHAGE Study: Bacteriophages as Novel Prebiotics
Condition: Gastrointestinal Disorder, Functional
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      The PHAGE study is designed to determine if a commercial prebiotic product can change the
      composition of bacteria in the gut for improved intestinal health. A prebiotic is defined as
      an indigestible dietary component that selectively enhances specific bacterial species in the
      intestines to confer a health benefit. In this study, the prebiotic a unique combination of
      bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe
      for human consumption and work by infecting bad bacteria in the gut, which allows beneficial
      bacteria populations to increase. The product, PreforPro, has shown to be effective in
      culture-based and animal studies, but its efficacy has not been demonstrated in humans. The
      goal of this study is to see if PreforPro consumption improves gut bacteria profiles in
      individuals relative to a placebo control and is associated with reduced incidence and
      severity of gastrointestinal distress.
    

Detailed description: 
      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.
    

Intervention name(s): Bacteriophage mixture; Placebo Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Four bacteriophage strains: LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae.; Placebo control capsule consisting of rice maltodextrin
Other intervention name(s): PreforPro; rice maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The PHAGE Study is a randomized, double-blind, placebo controlled crossover trial that investigates the utility of four supplemental bacteriophage strains (LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae) to modulate the gut microbiota, and therefore ameliorate common inflammation-related GI distress symptoms (e.g., gas, bloating, diarrhea, constipation, etc) experienced by healthy individuals.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dysbiosis; gut microbiota; bacteriophage; irritable bowel syndrome; gastrointestinal distress; prebiotic