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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dairy Management Inc.
Information provided by (Responsible Party):
Penny Kris-Etherton, Penn State University
ClinicalTrials.gov Identifier:
NCT01399996
First received: July 19, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Delayed Transit Time
Irregular Bowel Function
Dietary Supplement: Yogurt smoothie without probiotic
Dietary Supplement: Yogurt smoothie with probiotic added post fermentation
Dietary Supplement: Yogurt smoothie with probiotic added pre-fermentation
Dietary Supplement: A capsule containing the probiotic
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of a Delivery System on the Efficacy of a Probiotic Intervention

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Gastrointestinal transit time [ Time Frame: Weeks 4, 10, 16, 22 ] [ Designated as safety issue: No ]
    Gastrointestinal transit time is the amount of time it takes for food to travel through the digestive tract to be excreted. It will be measured using the SmartPill wireless motility capsule.


Secondary Outcome Measures:
  • Change from baseline in the fecal microbiota profile at 4 weeks following each of the 4 interventions and 1 free living period [ Time Frame: Weeks 4, 10, 16, 22 and 28 ] [ Designated as safety issue: No ]
  • Change from baseline in immune status at 4 weeks following each of the 4 interventions and 1 free living period [ Time Frame: Weeks 4, 10, 16, 22, 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: April 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Yogurt smoothie without probiotic. 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).
Other Name: Yogurt
Experimental: Probiotic added post fermentation. 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).
Other Name: Yogurt with probiotic
Experimental: Probiotic added pre-fermentation. 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).
Other Name: Yogurt with probiotic
Experimental: A capsule containing the probiotic. 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).
Other Name: Probiotic capsule

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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01399996

Locations
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
Dairy Management Inc.
Investigators
Principal Investigator: Penny M Kris-Etherton, PhD Penn State University
  More Information

Publications:
Responsible Party: Penny Kris-Etherton, Distinguished Professor of Nutrition, Penn State University
ClinicalTrials.gov Identifier: NCT01399996     History of Changes
Other Study ID Numbers: PKE PROBIOTIC
Study First Received: July 19, 2011
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
probiotic
microbiota
transit time
immunity
immune function
constipation
bowel function

ClinicalTrials.gov processed this record on August 28, 2014