NCT02355210

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Intestinal Microbiota and Barrier Function

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-08-01
• Completion: 2015-10-01
• First posted: 2015-02-04
• Last updated: 2021-11-23
• Results posted: 2021-11-23

Locations

1 site across 1 country: United States