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

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranberry juice
Amoxicillin
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring Vaccinium macrocarpon

Eligibility Criteria

6 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Outcomes

Primary Outcome Measures

Drug Elmination

Secondary Outcome Measures

Drug absorption

Full Information

First Posted
June 8, 2004
Last Updated
November 28, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00084201
Brief Title
Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections
Official Title
Cranberry: Interactions With Anti-Infectious Agents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Vaccinium macrocarpon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cranberry juice
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Primary Outcome Measure Information:
Title
Drug Elmination
Secondary Outcome Measure Information:
Title
Drug absorption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail D Anderson, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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

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