Home
Clinical Trials
NCT02355210

Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults

NCT ID: NCT02355210

Last Updated: 2021-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, we intend to test the ecological and therapeutic functionality of a synbiotic combination of a Bifidobacterium adolescentis strain and the prebiotic galactooligosaccharide (GOS) in a human clinical trial. The synbiotic combination was selected based on a novel in vivo selection; specifically, the strain (BD1) is an human autochthonous gut organism that was enriched in an individual by GOS. Our experiments will test the efficacy of this synbiotic compared to a conventional synbiotic. We hypothesize this rationally selected synbiotic will improve intestinal barrier function in obese adult subjects, thereby preventing endotoxemia and metabolic inflammation, physiologically relevant functions that are increased in obese individuals. Our objectives are to: (1) compare the ability of the test and control synbiotic preparations to alter the gut microbiota in obese individuals; (2) test if GOS supports colonization and metabolic activity of test and control strains in the human gut; (3) compare the ability of the two synbiotic preparations to improve intestinal permeability and endotoxemia in obese subjects; and (4) assess associations between the gut microbiota and the test strain with biomarkers for translocation and endotoxemia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intestinal Microbiota and Barrier Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

5 g lactose given as a placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

lactose powder, 5 grams

Probiotic 1

Bifidobacteria adolescentis BD1, 10\^9

Group Type EXPERIMENTAL

Bifidobacteria adolescentis BD1

Intervention Type DIETARY_SUPPLEMENT

packet containing 10\^9 cells of Bifidobacteria adolescentis BD1

Probiotic 2

Bifidobacteria animalis subsp. lactis BB-12, 10\^9

Group Type EXPERIMENTAL

Bifidobacteria animalis subsp. lactis BB-12

Intervention Type DIETARY_SUPPLEMENT

packet containing 10\^9 cells of Bifidobacteria animalis subsp. lactis BB-12

Prebiotic

galactooligosaccaride, 5 g

Group Type EXPERIMENTAL

galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

5 g galactooligosaccharide

Synbiotic 1

galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)

Group Type EXPERIMENTAL

Bifidobacteria adolescentis BD1 and galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

packet containing 10\^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide

Synbiotic 2

galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)

Group Type EXPERIMENTAL

Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

packet containing 10\^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bifidobacteria adolescentis BD1

packet containing 10\^9 cells of Bifidobacteria adolescentis BD1

Intervention Type DIETARY_SUPPLEMENT

Bifidobacteria animalis subsp. lactis BB-12

packet containing 10\^9 cells of Bifidobacteria animalis subsp. lactis BB-12

Intervention Type DIETARY_SUPPLEMENT

Bifidobacteria adolescentis BD1 and galactooligosaccharide

packet containing 10\^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide

packet containing 10\^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

galactooligosaccharide

5 g galactooligosaccharide

Intervention Type DIETARY_SUPPLEMENT

Placebo

lactose powder, 5 grams

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18-65 yrs, obese (30 kg/m2 and greater)

Exclusion Criteria

* (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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nebraska Lincoln

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Hutkins, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Lincoln

Jens Walter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 29954454 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

USDA-NIFA-AFRI-003397

Identifier Type: -

Identifier Source: org_study_id