BacterioPHAGE for Gastrointestinal Health 2 Study
Condition: Mild Gastrointestinal Symptoms in Healthy Adults
Study type: Interventional

Summary: 
      The BacterioPHAGE for Gastrointestinal Health-2 study is designed to determine if a
      commercial bacteriophage product can increase the survival and efficacy of probiotic bacteria
      that will be concurrently administered. Bacteriophages may act as prebiotics, which are
      traditionally defined as indigestible dietary components that selectively enhance specific
      bacterial species in the intestines to confer a health benefit. In this study, the
      "prebiotic" is a unique combination of bacteriophages, or viruses that infect bacteria. These
      phages are generally regarded as safe for human consumption and are presumed to function by
      infecting pro-inflammatory E. coli strains in the gut. The removal of these strains alters
      the gut environment to allow growth of more favorable bacteria, and the lysis products of
      these E. coli may be assimilated by beneficial species to enhance their populations.The phage
      product, PreforPro, has shown to be effective in culture-based and animal studies, but its
      efficacy in increasing specific probiotic species has not been demonstrated in humans. The
      investigators have previously shown that PreforPro is both safe and tolerable in a human
      population and does not broadly disrupt the gut microbiota as would be seen with antibiotic
      treatment.
    

Detailed description: 
      The commercial bacteriophage preparation,PreforPro, is often found as an ingredient in
      commercial probiotcs, so the goal of the current study is to determine if PreforPro
      consumption concurrent with probiotic usage improves probiotic survival and activity. A
      secondary goal of this study is to assess various physiologic parameters to determine whether
      consumption of PreforPro with a probiotic offers any health benefits beyond those of
      consuming a probiotic alone. The investigators will examine whether consumption of the
      PreforPro product increases detectable numbers of co-consumed probiotics and improves
      parameters in clinical outcomes related to glucose and lipid metabolism, cardiovascular
      function, inflammation of the intestines, or physical symptoms of gastrointestinal distress.

      To accomplish these research goals, the investigators will be seeking 200 male and female
      volunteers between 18-65 years old with BMI scores of 22 to 34.9. Recruitment will be by
      referral from local practitioners, email recruitment, and through word-of-mouth. Eligibility
      will be determined at the Colorado State University Food and Nutrition Clinical Research lab
      by a screening questionnaire and interview/assessment by the clinical coordinator. After
      securing consent, eligibility will be confirmed by taking anthropometric measures and
      participants falling within the BMI range will randomly be assigned to 1 of 3 treatment
      groups: (1) PreforPro+Bifidobacterium probiotic, (2) Bifidobacterium probiotic alone, or (3)
      placebo. Participants will consume the provided capsules daily for a period of four (4)
      weeks. Participants will be asked to visit the clinic at Visit 1 (Day 0) to pick up their
      supply of capsules and undergo sample collections (blood and stool) and analysis procedures,
      including weight/height, blood pressure, endothelial function analysis, gastrointestinal
      symptom screening, and blood and stool sample collection. At the end of the 4 week treatment
      period, all analyses will be repeated. This means that participants will undergo screening
      (either in person or by phone) and make a total of two (2) clinic visits during the study
      (baseline, and final visit). Participants will additionally be asked to complete two 24 hour
      dietary recalls prior to each clinic visit and track bowel movements using the Bristol Stool
      Scale throughout the study treatment period. All blood samples will be collected at Colorado
      State University by trained personnel. Fecal sample collection will be performed by the study
      participant with collection materials provided.
    

Intervention name(s): Bifidobacterium animals subsp. lactis BL04+PreforPro; Bifidobacterium animals subsp. lactis BL04; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): One 15mg capsule taken orally each day; One 15mg capsule taken orally each day; One 15mg capsule taken orally each day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blinded, placebo controlled, parallel arm
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: gastrointestinal; probiotic; bacteriophage; Bifidobacterium animalis subspecies lactis