NCT02355210|CompletedResults
Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults
Application of a Novel Synbiotic to Modulate the Human Gut Microbiota and Improve Health
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Sponsor study identifier
interventional
151
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
October 2015
Actual (reported)This study evaluates the effect of a dietary supplement to improve gut health. The participants will take one of six dietary treatments for three weeks, and the gut bacteria and the gut intestinal barrier will be assessed to determine if these dietary treatments beneficially change these markers of gut health.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2015
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.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 30, 2015
Actual (reported)February 4, 2015
Actual (reported)August 2015
Actual (reported)October 2015
Actual (reported)November 23, 2021
Actual (reported)Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12
change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12
baseline and three weeks
Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine
Change in intestinal permeability as measured by change in percent sugars in urine
baseline and three weeks
Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein
baseline and three weeks
5 g lactose given as a placebo
Bifidobacteria adolescentis BD1, 10\^9
Bifidobacteria animalis subsp. lactis BB-12, 10\^9
packet containing 10\^9 cells of Bifidobacteria adolescentis BD1
packet containing 10\^9 cells of Bifidobacteria animalis subsp. lactis BB-12
Rush University Medical Center
Chicago, Illinois, 60612, United States
Krumbeck JA, Rasmussen HE, Hutkins RW, Clarke J, Shawron K, Keshavarzian A, Walter J. Probiotic Bifidobacterium strains and galactooligosaccharides improve intestinal barrier function in obese adults but show no synergism when used together as synbiotics. Microbiome. 2018 Jun 28;6(1):121. doi: 10.1186/s40168-018-0494-4.
Robert Hutkins, PhD
University of Nebraska Lincoln
Jens Walter, PhD
University of Alberta
151 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2015
First Posted
February 4, 2015
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
galactooligosaccaride, 5 g
galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)
galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)
packet containing 10\^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide
packet containing 10\^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide
5 g galactooligosaccharide
lactose powder, 5 grams
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 2015
Actual (reported)Study Completion
October 2015
Actual (reported)Last Updated
November 23, 2021
Results First Posted
November 23, 2021
Record last verified: 2021-11
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.
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