Carbohydrate induced resilience of the gut microbiome after antibiotics use

Completed

Conditions: Gut microbiome dysbiosis
10017943
10018424

Registration Number: NL-OMON55342

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Healthy overweight/obese (BMI: 25-40 kg/m^2) Caucasian adults (age: 20-65
years), male and female, with a stable body weight (< 3 kg change) for the last
3 months.

Exclusion Criteria

- Known allergic reaction to vancomycin or other glycopeptide antibiotics;
- Pre-diabetes, diabetes mellitus, cardiovascular disease, kidney disease,
hearing disorders, cancer, asthma or bronchitis, liver malfunciton, diseases
affecting glucose tolerance, major illness with a life expectancy < 5 years,
gastrointestinal disease or abdominal surgery,
- Abuse of products; alcohol and drugs, excessive nicotine use defined as > 20
cigarettes per day;
- Regular use of laxation products;
- Use of antibiotics in the past 3 months;
- Regular supplementation of pre- or probiotics products, use of pre- or
probiotics 3 months prior to the start of the study;
- Plans to lose weight or currently following a hypocaloric diet;
- Following a vegan diet;
- Participation in organized sports activities for > 3 hours per week.
- Suffering from hearing loss or other hearing problems.
- Currently pregnant, planning to become pregnant or currently breastfeeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome parameter will be microbiome resilience, which will be<br /><br>described as the change in gut microbiome composition and activity between<br /><br>baseline, after antibiotics use and during/after 2'-FL/placebo supplementation.<br /><br>This parameter will be investigated at six different timepoints throughout the<br /><br>study. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome parameters of the study are BMI, waist-to-hip ratio, body<br /><br>composition, glucose tolerance, fat metabolism, adipose tissue gene and protein<br /><br>expression and levels of short-chain fatty acids, inflammatory markers and<br /><br>satiety hormones in the blood. These parameters will be investigated on three<br /><br>different timepoints during the study: at baseline, after antibiotics use and<br /><br>after the supplementation period. </p><br>