Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100061
Status:
UNKNOWN
Last Update Posted:
2013-03-12
First Post:
2004-12-22
Brief Title:
Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections UTIs
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Dose Response to Cranberry of Women With Recurrent UTIs
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections UTIs
Detailed Description:
Although cranberry-containing products are commonly taken to prevent UTIs and other urinary symptoms an optimally effective dose has not been established and the chemicals responsible for the UTI-preventing properties in cranberry-containing products have yet to be determined This study will determine the minimum dose of cranberry-containing product necessary to prevent UTIs the effectiveness of cranberry-containing products in fighting different strains of E coli and the long-term effects of cranberry-containing product consumption This study will also determine whether plant pigments called proanthocyanidins influence the UTI-preventing properties of cranberry-containing products
This study will last 2 years Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year Some participants will receive cranberry or placebo supplement tablets others will receive cranberry juice or a placebo beverage Clinic visits will occur every 2 months urine collection will occur at each visit Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1 3 5 and 7
Laboratory tests will be used to assess participants during the study A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred
This study will last 2 years Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year Some participants will receive cranberry or placebo supplement tablets others will receive cranberry juice or a placebo beverage Clinic visits will occur every 2 months urine collection will occur at each visit Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1 3 5 and 7
Laboratory tests will be used to assess participants during the study A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None