Clinical trial: Effects of a Cranberry Beverage on Women With Recent History of Urinary Tract Infections (NCT01776021)

Eligibility criteria:
Inclusion Criteria:

          1. Subject has had at least 2 episodes of a UTI treated by a healthcare professional in
             the last year and at least 1 treated UTI within the last 6 months.

          2. Subject is willing to avoid listed Vaccinium products (including cranberry juice,
             cranberries, craisins, blueberries, cranberry/blueberry powders, pills, or
             supplements, probiotics) for 2 weeks prior to enrollment and throughout intervention.

          3. Subject agrees to avoid probiotic dietary supplements for 2 weeks prior to enrollment
             and throughout intervention.

          4. Subject agrees to limit all probiotic-containing foods/yogurt and yogurt-containing
             products to no more than an 8 oz serving/d within 2 weeks prior to enrollment and
             throughout intervention.

          5. Subject is willing to limit all soda, pop or energy drinks (diet or regular sweetened)
             to < 20 oz/d within 2 weeks prior to and throughout intervention.

        Exclusion Criteria:

          1. Subject has an in-dwelling catheter, polycystic disease, interstitial cystitis,
             previous urological surgery, stones, or anatomical abnormalities of the urinary tract,
             spinal cord injury, immuno-compromised conditions, severe renal impairment, or
             multiple sclerosis.

          2. Subject has a history of antibiotic prophylaxis use for UTI. A 2-week washout period
             prior to enrollment will be allowed.

          3. Subject has a body mass index (BMI) >40.0 kg/m2.

          4. Subjects with diabetes mellitus and HbA1C >8.0% prior to enrollment.

          5. Subject has diabetes mellitus treated with insulin.

          6. Subject has an active infection or sign/symptoms of an infection (i.e., including a
             UTI).

          7. Subject has used oral anti-coagulants within the last 4 weeks.

          8. Subject has a history or presence of cancer in the prior two years, except for
             nonmelanoma skin cancer.

          9. Subject is pregnant, planning to be pregnant during the study period, lactating, or is
             of childbearing potential and is unwilling to commit to the use of a medically
             approved form of contraception throughout the study period.
Female
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0