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

NCT02355210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2021-11-23

Study results available
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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.

Conditions

  • Intestinal Microbiota and Barrier Function

Interventions

DIETARY_SUPPLEMENT

Bifidobacteria adolescentis BD1

packet containing 10\^9 cells of Bifidobacteria adolescentis BD1

DIETARY_SUPPLEMENT

Bifidobacteria animalis subsp. lactis BB-12

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

DIETARY_SUPPLEMENT

Bifidobacteria adolescentis BD1 and galactooligosaccharide

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

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

DIETARY_SUPPLEMENT

galactooligosaccharide

5 g galactooligosaccharide

DIETARY_SUPPLEMENT

Placebo

lactose powder, 5 grams

Sponsors & Collaborators

  • University of Nebraska Lincoln

    collaborator OTHER
  • University of Alberta

    collaborator OTHER
  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Robert Hutkins, PhD · University of Nebraska Lincoln

  • Jens Walter, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355210 on ClinicalTrials.gov