Influence of a Delivery System on the Efficacy of a Probiotic Intervention
1 other identifier
interventional
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 21, 2023
August 1, 2023
2.2 years
July 19, 2011
August 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gastrointestinal transit time
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.
Weeks 4, 10, 16, 22
Secondary Outcomes (2)
Change from baseline in the fecal microbiota profile at 4 weeks following each of the 4 interventions and 1 free living period
Weeks 4, 10, 16, 22 and 28
Change from baseline in immune status at 4 weeks following each of the 4 interventions and 1 free living period
Weeks 4, 10, 16, 22, 28
Study Arms (4)
Yogurt smoothie without probiotic.
PLACEBO COMPARATORProbiotic added post fermentation.
EXPERIMENTALProbiotic added pre-fermentation.
EXPERIMENTALA capsule containing the probiotic.
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- Generally healthy
- Men and women
- 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.
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penn State Universitylead
- Dairy Management Inc.collaborator
Study Sites (1)
Penn State University
University Park, Pennsylvania, 16802, United States
Related Publications (4)
Drossman DA, Dumitrascu DL. Rome III: New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41.
PMID: 17013448BACKGROUNDBa Z, Lee Y, Meng H, Kris-Etherton PM, Rogers CJ, Lewis ZT, Mills DA, Furumoto EJ, Rolon ML, Fleming JA, Roberts RF. Matrix Effects on the Delivery Efficacy of Bifidobacterium animalis subsp. lactis BB-12 on Fecal Microbiota, Gut Transit Time, and Short-Chain Fatty Acids in Healthy Young Adults. mSphere. 2021 Aug 25;6(4):e0008421. doi: 10.1128/mSphere.00084-21. Epub 2021 Jul 7.
PMID: 34232082DERIVEDLee Y, Ba Z, Roberts RF, Rogers CJ, Fleming JA, Meng H, Furumoto EJ, Kris-Etherton PM. Effects of Bifidobacterium animalis subsp. lactis BB-12(R) on the lipid/lipoprotein profile and short chain fatty acids in healthy young adults: a randomized controlled trial. Nutr J. 2017 Jun 29;16(1):39. doi: 10.1186/s12937-017-0261-6.
PMID: 28662676DERIVEDMeng H, Lee Y, Ba Z, Peng J, Lin J, Boyer AS, Fleming JA, Furumoto EJ, Roberts RF, Kris-Etherton PM, Rogers CJ. Consumption of Bifidobacterium animalis subsp. lactis BB-12 impacts upper respiratory tract infection and the function of NK and T cells in healthy adults. Mol Nutr Food Res. 2016 May;60(5):1161-71. doi: 10.1002/mnfr.201500665. Epub 2016 Mar 1.
PMID: 26821116DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penny M Kris-Etherton, PhD
Penn State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2011
First Posted
July 22, 2011
Study Start
April 1, 2012
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
August 21, 2023
Record last verified: 2023-08