Effectiveness of Cranberry Ingestion on Bacterial Adhesion: An Adjunct Study

NCT00506025 | Completed Results

• 1 other identifier: 2006-4896
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to help determine if drinking cranberry juice can decrease risk for asymptomatic bacteriuria (ASB). ASB occurs when there are bacteria in the urine without any symptoms. It will also see if there is a difference in this effect between pregnant and non-pregnant women.This research project is also designed to see what happens to bacterial binding to the lining of the bladder after drinking cranberry juice when special problems occur with pregnancy such as diabetes (a sugar metabolism problem) or ASB is already occurring.

Conditions

Asymptomatic Bacteriuria

Keywords

Pregnancy; Cranberry; Asymptomatic Bacteruria

Outcome Measures

Primary Outcomes (1)

• Antimicrobial Activity of Urine From Pregnant Subjects Following Cranberry Juice Cocktail (CJC)

  The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).

  7 months, from enrollment at 3 months of pregnancy to delivery

Study Arms (3)

Cranberry 2xday

ACTIVE COMPARATOR

Cranberry juice (C) two times daily, a.m. and p.m.

Dietary Supplement: Cranberry Juice

Cranberry + Placebo

ACTIVE COMPARATOR

De-Activated Cranberry juice in the am, then placebo (P) in the pm

Dietary Supplement: Cranberry Juice

Placebo 2xday

PLACEBO COMPARATOR

Placebo in the form of juice two times daily in the a.m. and p.m.

Dietary Supplement: De-Activated Cranberry juice

Interventions

Cranberry Juice DIETARY_SUPPLEMENT

Low-calorie, Low-carbohydrate content 8 oz dose of Cranberry juice

Cranberry + Placebo; Cranberry 2xday

De-Activated Cranberry juice DIETARY_SUPPLEMENT

De-Activated Cranberry juice in the am, then placebo (P) in the pm

Placebo 2xday

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Intrauterine pregnancy
• Documented fetal viability (either by fetal heart tones present by Doppler auscultation, or by ultrasonic visualization of cardiac motion
• Estimated gestational age by last menstrual period and/or by ultrasonographic fetal measurements of 16 weeks or less

You may not qualify if:

• Suspected non-viable or ectopic gestation
• Patient desires pregnancy termination
• Significant underlying medical complication, such as chronic hypertension, insulin-requiring diabetes, chronic renal failure, cardiac disease, sickle cell disease, etc.
• Maternal age less than 18 years
• Patient is currently on or has received within the two weeks prior to enrollment antimicrobial therapy for reasons other than urinary tract infection.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Limitations and Caveats

Our study methodology could have been improved with a series of timed urine collections such as collections at pre-treatment, 2, 4 and 6 hours after ingestion of the cranberry juice cocktail and placebo to determine time of maximal effect.

Results Point of Contact

• Title: Deborah A. Wing, MD
• Organization: University of California Irvine Medical Center

dwing@uci.edu

714-456-5967

Study Officials

• Deborah A Wing, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Maternal-Fetal Medicine, Obstetrics & Gynecology, University of California, Irvine School of Medicine

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 25, 2007
• Study Start: August 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: December 18, 2017
• Results First Posted: June 8, 2010

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)