NCT01399996|CompletedPhase 1
Loading search results
Sponsor study identifier
interventional
36
1 country
1
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 19, 2011
Actual (reported)July 22, 2011
Actual (reported)April 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2014
Actual (reported)August 2014
Actual (reported)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
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
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).
Penn State University
University Park, Pennsylvania, 16802, United States
Drossman DA, Dumitrascu DL. Rome III: New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41.
Ba 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.
Penny M Kris-Etherton, PhD
Penn State University
36 participants (actual enrollment reported by the registry).
First Submitted
July 19, 2011
First Posted
July 22, 2011
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Lee 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.
Meng 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.
Primary Completion
July 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
August 21, 2023
Record last verified: 2023-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: