Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00084201
First received: June 8, 2004
Last updated: November 28, 2006
Last verified: November 2006

June 8, 2004
November 28, 2006
July 2006
Not Provided
Drug Elmination
Not Provided
Complete list of historical versions of study NCT00084201 on ClinicalTrials.gov Archive Site
Drug absorption
Not Provided
Not Provided
Not Provided
 
Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections
Cranberry: Interactions With Anti-Infectious Agents

The purpose of study is to determine whether cranberry juice interacts with antibiotics used to treat urinary tract infections (UTIs).

Although evidence of its effectiveness is limited, cranberry juice is widely used to prevent urinary tract infections (UTIs). However, recent studies have shown that cranberry juice may affect the way the body absorbs and metabolizes antibiotics used to treat UTIs. This study will determine whether concurrent cranberry juice administration lowers the urinary concentrations of two commonly used antibiotics, amoxicillin and cefaclor.

This study will involve children being treated for UTIs and adults without UTIs. All of the children will continue their prescribed amoxicillin/cefaclor treatment. After 7 to 10 days of antibiotic treatment, the children will be assigned to receive either cranberry juice for 2 days or no additional treatment. Urine samples will be collected from all child participants before and after the administration of cranberry juice to examine the excretion of the antibiotics.

Adult participants will receive two different doses of amoxicillin, with or without cranberry juice. Blood and urine samples will be collected to evaluate the effect of cranberry juice on the absorption and elimination of amoxicillin.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Tract Infections
  • Drug: Cranberry juice
  • Drug: Amoxicillin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2007
Not Provided

Inclusion Criteria for Children:

  • Urinary tract infection (UTI) treated with cefaclor or amoxicillin

Inclusion Criteria for Adults:

  • No UTI

Exclusion Criteria:

  • Allergies to antibiotics
  • Use of medications other than oral contraceptives
  • Pregnancy or breast-feeding
  • Smoker
Both
6 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00084201
R21 AT002077-01
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Gail D Anderson, PhD University of Washington
National Center for Complementary and Alternative Medicine (NCCAM)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP