A Phase 2 interventional study of Cranberry juice cocktail in Urinary Tract Infections, sponsored by National Center for Complementary and Integrative Health (NCCIH). Completed at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-06-04.
Sponsored by National Center for Complementary and Integrative Health (NCCIH) · Phase 2, Interventional, and Prevention
This study will determine whether cranberry juice is effective in reducing recurrent urinary tract infections (UTIs) in women who have had a UTI within the past year.
UTIs are a common problem among young women, resulting in considerable morbidity and health care costs. Increasing resistance to antibiotics is making treatment of these infections even more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are needed. One approach that appears to be effective is the use of cranberry products. However, data on the safety and effectiveness of cranberry products are limited. This study will determine whether cranberry juice can reduce UTIs in women.
Participants will be randomly assigned to receive either cranberry juice or a placebo drink daily for 6 months. Study visits will occur every month for the 6-month treatment phase of the study. At study entry and at each study visit, urine collection will occur and vaginal swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4 visits. Participants will be asked about medication usage, any side effects they may be experiencing, and diet at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours.
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's enrollment of 176 is above the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →National Center for Complementary and Integrative Health (NCCIH) is the lead sponsor of 223 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Cranberry Juice Cocktail- 4 ounces
Drug: Cranberry juice cocktail
Cranberry Juice Cocktail-8 ounces
Drug: Cranberry juice cocktail
Placebo- 4 ounces
Drug: Cranberry juice cocktail
Placebo- 8 ounces
Drug: Cranberry juice cocktail
Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Also known as: CJC, cranberry
Rate of UTIs
Time frame: 6 months
Compliance
Time frame: 6 months
vaginal and rectal colonization with E. coli
Time frame: 6 months
The record gives a start of Aug 2005, a primary completion of Dec 2008 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cranberry
National Center for Complementary and Integrative Health (NCCIH) →