Evaluation of Jarro-Dophilus EPS® Probiotic Formulations
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of the two doses of Jarro-Dophilus EPS®
      probiotic supplements on fecal lactobacillus and bifidobacteria numbers, transit survival of
      administered probiotic strains, fecal microbiota, gastrointestinal function and general
      wellbeing in healthy human adults.
    

Detailed description: 
      Participants will be screened using the International Physical Activity Questionnaire
      (questions regarding physical activity, including intensity, duration and frequency) and
      inclusion/exclusion criteria. Participants will be scheduled to begin a 7-day baseline
      period, during which participants will complete daily questionnaires of bowel movement
      frequency, gastrointestinal symptoms and wellness. On or about day 8, height and weight will
      be determined. Participants will then be randomized to one of the following groups:

      Group 1: Jarro-Dophilus EPS® (5 billion CFU/capsule), Group 2: Jarro-Dophilus EPS® Higher
      Potency (25 billion CFU/capsule), Group 3: Placebo capsule

      Study participants will continue to complete the daily online questionnaire throughout the 28
      days of treatment and for 7 days post treatment. Participants will also be asked to complete
      a weekly questionnaire on gastrointestinal symptoms (Gastrointestinal Symptom Rating Scale)
      throughout the entire study. In addition, participants in each group will be asked to collect
      one stool sample at baseline, one stool sample during week 4 of treatment and an additional
      sample during the washout period. Stool samples will be analyzed and quantified for the
      probiotic bacteria and changes in the microbiota.

      Participants will be asked to return any unconsumed supplements at the end of the treatment
      period. Additionally, the participants will be weighed after the treatment period and the
      washout period.
    

Intervention name(s): Jarro-Dophilus EPS® (5 billion CFU/capsule); Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): One capsule containing 5 billion CFU of the probiotic mix (Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus casei, Pediococcus acidilactici, Bifidobacteria breve, Bifidobacteria longum, Lactobacillus plantarum and Lactobacillus lactis ssp. lactis) will be taken once a day for a period of 28 days.; One capsule containing 25 billion CFU of the probiotic mix (Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus casei, Pediococcus acidilactici, Bifidobacteria breve, Bifidobacteria longum, Lactobacillus plantarum and Lactobacillus lactis ssp. lactis) will be taken once a day for a period of 28 days.; One capsule (containing potato starch, magnesium stearate and ascorbic acid) will be taken once a day for a period of 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Jarro-Dophilus; probiotic; microbiota; gastrointestinal