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Carbohydrate induced resilience of the gut microbiome after antibiotics use

Carbohydrate induced resilience of the gut microbiome after antibiotics use - The CARMA study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55342
Enrollment
40
Registered
2020-07-07
Start date
2020-11-27
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut microbiome dysbiosis

Interventions

During the first 7 da7s of the study period, all participants will be provided with the antibiotic vancomycin. Participants will be asked to take two capsules of 250 mg three times per day for 7 day

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 (

Exclusion criteria

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 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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)