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

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.

Inclusion Criteria:

- Generally healthy

- Men and women

- 18-40 years of age

- Body mass index between 20 and 35 kg/m^2

- Persons with irregular bowel function as determined using the Rome III criteria (1)
which is used to classify functional gastrointestinal disorders.

- Increased gastrointestinal transit time > 60 hours.

Exclusion Criteria:

- Smoking and/or use of other tobacco products

- Blood pressure greater than 140/90 mm Hg

- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney
disease and thyroid disease (unless controlled by medication and blood results within
the previous 6 months are provided).

- Lactation, pregnancy or desire to become pregnant during the study

- Use of cholesterol-lowering medication

- Refusal to discontinue intake of putative cholesterol-lowering supplements (psyllium,
fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, stanol/sterol
supplemented foods

- Refusal to discontinue probiotics,nutritional supplements, herbs or vitamins

- Vegetarianism/Veganism

- Lactose intolerance

- Clinical diagnosis of Inflammatory Bowel Disease (IBD), e.g. Crohn's Disease or
ulcerative colitis

- Excessive alcohol consumption (> 14 standard drinks per week)

- Chronic use of anti-inflammatory medications (unless able to discontinue)

- Individuals taking stool softeners or enemas on a regular basis.

- Allergy to polyvinyl chloride (PVC) or any other type of plastic

- Individuals with a bowel transit time of < 60 hours at time of screening

- Individuals with swallowing disorders or dysphagia to food or pills

- Suspected strictures, fistulas, or physiological GI Obstruction

- GI surgery within the past three months

- Refusal to agree to give blood or plasma for the length of the study.

Note: If a participant experiences a delay in passing the capsule (beyond five days) they
will be treated accordingly and excluded from future participation in the study.