NCT01399996

Influence of a Delivery System on the Efficacy of a Probiotic Intervention

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Penn State University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Delayed Transit Time
• Irregular Bowel Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Yogurt smoothie without probiotic	A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
DIETARY_SUPPLEMENT	Yogurt smoothie with probiotic added post fermentation	A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
DIETARY_SUPPLEMENT	Yogurt smoothie with probiotic added pre-fermentation	A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
DIETARY_SUPPLEMENT	A capsule containing the probiotic	A capsule taken daily will provide between 10x\^y9 and 10x\^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2011-07-22
• Last updated: 2023-08-21

Locations

1 site across 1 country: United States