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Effect antibiotics on gutmicrobiota composition & insulin resistance.

Effect of antibiotics on gut microbiota composition & insulin resistance in obese humans: Amoxycillin-vs-vancomycin trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24894
Enrollment
20
Registered
2010-10-15
Start date
2011-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

insulin resistance, obesity

Interventions

Patients will be randomised to either 7 days amoxicillin 500mg 3dd or 7 days vancomycin 500mg 3dd.

Sponsors

Academic Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male obese subjects with metabolic syndrome (BMI > 30kg/m2, FPG>5.6 mmol/l); 2. Age 20-65 yr; 3. No medication use.

Exclusion criteria

Exclusion criteria: 1. Patients with renal failure (kreatinine>135mmol/l); 2. Liver function problems (ASAT/ALAT>2x upper limit); 3. Hypersensitivity to penicillin, amoxicillin, other beta lactams or chinolones; 4. Patients with medication known to interfere with glucose metabolism or bile acid composition (sequestrants, chenodiole, ursochol); 5. Patients with infectious mononucleosis; 6. Asthmatic patients; 7. Antibiotic use last three months; 8. Disorders known to interfere with bile acid metabolism (intestine resection, liver/intestine disorders); 9. History of laparoscopic cholecystectomy; 10. Patients with idiopathic diarrhea.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is changes in faecal flora composition after 7 days as well as 2, 4 and 6 weeks after the antibiotics.

Secondary

MeasureTime frame
1. Changes in insulin resistance (assessed by hyperinsulinemic normoglycemic clamp at baseline and after 7 days); 2. Bile acid and lipidmetabolism (assessed by MMT at baseline and after 7 days); 3. Changes in systemic inflammatory markers and lipid profiles at baseline as well as 7 days, 2, 4 and 6 weeks after antibiotics.

Contacts

Public ContactA. Vrieze

PO Box 22660

a.vrieze@amc.uva.nl+31 (0)20 5665983

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)