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

Not Applicable

Completed

Interventions: Dietary Supplement: Bifidobacteria adolescentis BD1
Dietary Supplement: galactooligosaccharide
Dietary Supplement: Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide
Dietary Supplement: Bifidobacteria adolescentis BD1 and galactooligosaccharide
Dietary Supplement: Bifidobacteria animalis subsp. lactis BB-12
Dietary Supplement: Placebo

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.

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Probiotic 1	Bifidobacteria adolescentis BD1	Bifidobacteria adolescentis BD1, 10\^9
Prebiotic	galactooligosaccharide	galactooligosaccaride, 5 g
Synbiotic 2	Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide	galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)
Synbiotic 1	Bifidobacteria adolescentis BD1 and galactooligosaccharide	galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)
Probiotic 2	Bifidobacteria animalis subsp. lactis BB-12	Bifidobacteria animalis subsp. lactis BB-12, 10\^9
Placebo	Placebo	5 g lactose given as a placebo

Primary Outcome Measures

Name	Time	Method
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12	baseline and three weeks	change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12
Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine	baseline and three weeks	Change in intestinal permeability as measured by change in percent sugars in urine

Secondary Outcome Measures

Name	Time	Method
Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein	baseline and three weeks	Endotoxemia, as measured by change in circulating endotoxin by lipopolysaccharide and lipopolysaccharide-binding protein