Influence of a Delivery System on the Efficacy of a Probiotic Intervention
Condition: Delayed Transit Time; Irregular Bowel Function
Study type: Interventional
Phase: Phase 1

Summary: 
      In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium
      animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or
      after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time);
      2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human
      volunteers. In addition to providing information about the relative efficacy of the delivery
      vehicles on probiotic function it will provide novel information about the influence of the
      yogurt smoothie alone (control) on all the parameters measured.
    

Detailed description: 
      Probiotics (health-promoting bacteria) are often considered "functional ingredients" that act
      independently of the matrix used to deliver them to the human host. This thinking ignores the
      impact the delivery matrix (food or dietary supplement) may have on both the physiology of
      the probiotic organism and on the human host and is likely not true.

      Historically the most common "probiotic foods" have been fermented dairy products,
      particularly yogurts. Since yogurts are commonly understood to contain live "good" bacteria
      they are well accepted by consumers. However, increasingly over the last decade, probiotics
      are being added to non-dairy-based foods (juice, chocolate, cookies, etc) or consumed as
      supplements (tablets/capsules). While this expands the options for people to obtain probiotic
      organism, it is not clear whether probiotics delivered in these products are as efficacious
      as when delivered in a dairy food. In fact, the buffering capacity and nutrient composition
      of milk products may directly influence efficacy of the probiotic by increasing survival
      during passage through the gastrointestinal tract (GIT) and by modifying the physiology of
      the probiotic organism. In addition, fermentation products produced by the probiotic during
      manufacture of yogurt may also have an influence on the efficacy of probiotic bacteria.

      Our hypotheses are:

        1. The vehicle used to deliver probiotic bacteria into the body influences the performance
           of the probiotic in vivo. Specifically, consumption of yogurt-based smoothie containing
           probiotic bacteria will result in greater decrease in fecal transit time, and have a
           greater effect on the composition of the fecal microbiota and on markers of immune
           status than the same probiotic bacteria delivered at the same level in the form of a
           dietary supplement (tablet).

        2. Timing of the addition of probiotic organism to the yogurt smoothie (pre or post
           fermentation) will not change the efficacy of the probiotic with respect to the outcomes
           being assessed.
    

Intervention name(s): Yogurt smoothie without probiotic; Yogurt smoothie with probiotic added post fermentation; Yogurt smoothie with probiotic added pre-fermentation; A capsule containing the probiotic
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).; A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).; A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).; A capsule taken daily will provide between 10x^y9 and 10x^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
Other intervention name(s): Yogurt; Yogurt with probiotic; Yogurt with probiotic; Probiotic capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: probiotic; microbiota; transit time; immunity; immune function; constipation; bowel function