N/A
Completed N=107
Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults
Intestinal Microbiota and Barrier Function
Source: ClinicalTrials.gov NCT02355210 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 — 7.9; 9.1; 8.8; 6.0 percentage of bacterial taxa
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 |
7.9; 9.1; 8.8; 6.0; 8.7; 11.3 | — |
| PRIMARY Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine |
0.32; 0.34; 0.34; 0.32; 0.36; 0.37 | — |
| SECONDARY Endotoxemia, as Measured by Change in Circulating Endotoxin by Lipopolysaccharide and Lipopolysaccharide-binding Protein |
0.02; 0.03; 0.3; 0.02; 0.02; 0.02 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02355210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.