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
1 other identifier
interventional
151
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Typical duration for not_applicable
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
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 30, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
November 23, 2021
CompletedNovember 23, 2021
November 1, 2021
2.2 years
January 30, 2015
June 24, 2018
November 19, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein
baseline and three weeks
Study Arms (6)
Placebo
PLACEBO COMPARATOR5 g lactose given as a placebo
Probiotic 1
EXPERIMENTALBifidobacteria adolescentis BD1, 10\^9
Probiotic 2
EXPERIMENTALBifidobacteria animalis subsp. lactis BB-12, 10\^9
Prebiotic
EXPERIMENTALgalactooligosaccaride, 5 g
Synbiotic 1
EXPERIMENTALgalacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)
Synbiotic 2
EXPERIMENTALgalacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)
Interventions
packet containing 10\^9 cells of Bifidobacteria adolescentis BD1
packet containing 10\^9 cells of Bifidobacteria animalis subsp. lactis BB-12
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
Eligibility Criteria
You may qualify if:
- yrs, obese (30 kg/m2 and greater)
You may not qualify if:
- (1) prior intestinal resection, (2) patient history of GI diseases except for hiatal hernia, GERD, hemorrhoids, (3) severe renal disease defined by creatinine more than twice normal, (4) markedly abnormal liver function defined by ALT/AST over 4 times normal levels or elevated bilirubin (5) antibiotic use within the last 12 weeks prior to enrollment, (6) lean or overweight (BMI \< 30 kg/m2), (7) intolerant to aspirin, (8) regular use of aspirin, (9) excessive alcohol intake (\>2 drinks for men, 1 drink for women daily), (10) presence of uncontrolled chronic metabolic disease (cardiovascular disease, insulin requiring diabetes or uncontrolled diabetes, cancer, etc, (11) a plan to have a major change in dietary habit during the following 6 months, (12) consumption of probiotics, prebiotics or synbiotics without an appropriate 4 week washout period, (13) lactose intolerance or malabsorption; (14) subjects younger than 18 or older than 65, (15) unwillingness to consent to the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rush University Medical Centerlead
- University of Nebraska Lincolncollaborator
- University of Albertacollaborator
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60612, United States
Related Publications (1)
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.
PMID: 29954454DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Heather Rasmussen, Assistant Professor
- Organization
- University of Nebraska-Lincoln
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Hutkins, PhD
University of Nebraska Lincoln
- PRINCIPAL INVESTIGATOR
Jens Walter, PhD
University of Alberta
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2015
First Posted
February 4, 2015
Study Start
June 1, 2013
Primary Completion
August 1, 2015
Study Completion
October 1, 2015
Last Updated
November 23, 2021
Results First Posted
November 23, 2021
Record last verified: 2021-11