The Role of the Microbiota in the Systemic Immune Response

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study is to investigate the role of the gut microbiota in the systemic priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will be treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days, in order to deplete the gut microbiota. Blood and faeces will be sampled before, 24 hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation assay) and gut microbiota composition.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: W.J. Wiersinga, MD, PhD
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Ciprofloxacin; Metronidazole; Vancomycin

Criteria

Inclusion Criteria:

• Healthy

• Male between 18 and 35 years of age

• Capable of giving written informed consent and able to comply with the requirements and restrictions

• Chemistry panel without any clinically relevant abnormality

• Normal defecation pattern (defined as <3x/ day and >3x/week)

Exclusion Criteria:

• Major illness in the past 3 months or significant chronic medical illness;

• History of any type of malignancy;

• Past or current gastrointestinal disease which may influence the gut microbiota;

• Known positive test for hepatitis C antibody, hepatitis B surface antigen or HIV;

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities;

• Use of tobacco products;

• History, within 3 years, of drug abuse;

• History of alcoholism and/or drinking more than 3 units of alcohol per day;

• The subject has received an investigational product within three months of day 1;

• Use of prescription or non-prescription drugs and herbal and dietary supplements within 6 months;

• Recent (< 12 months) use of antibiotics (any kind, except for dermal antibiotics);

• Allergy to antibiotics (any kind);

• Difficulty swallowing pills;

• Any other relevant issue.