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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00084201
Other study ID # R21AT002077-01
Secondary ID
Status Completed
Phase N/A
First received June 8, 2004
Last updated November 28, 2006
Start date July 2006
Est. completion date June 2007

Study information

Verified date November 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 50 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Cranberry juice

Amoxicillin


Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug Elmination
Secondary Drug absorption
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