Actively Recruiting
A Randomized, Parallel, Controlled Trial Investigating the Effects of Cranberry-Based Products on the Female Microbiome
Led by Ocean Spray Cranberries, Inc. · Updated on 2025-08-14
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of a cranberry-based product with a placebo on the vaginal and gastrointestinal (GI) microbiomes in generally healthy pre-menopausal women aged 18 to 45 years. The study focuses on how cranberry compounds, especially polyphenols like proanthocyanidins, may influence microbial communities in the genitourinary and gut areas and impact related health outcomes. Participants will be randomly assigned to one of two groups: one group consumes 8 ounces of a cranberry beverage daily, while the other consumes a placebo beverage of the same volume each day. The study is controlled and parallel in design, with treatments given over a period of four weeks to assess the effects on microbiome composition and participant-reported outcomes. During the study, participants will undergo assessments including vaginal microbiome analysis, vaginal pH measurements, GI microbiome evaluation, and questionnaires on vaginal health, gastrointestinal symptoms, quality of life, and stool consistency. These evaluations occur over the four-week treatment period. Safety and adherence to the protocol will be monitored, with total participation lasting the treatment duration plus any necessary follow-up visits.
CONDITIONS
Brief Title
The Effect Cranberry-Based Products on the Female Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-menopausal female
- Age between 18 and 45 years inclusive at visit 1
- History of regular menstrual cycles (21-35 days per cycle or as judged by investigator) for at least 3 months before visit 1
- Stable use of contraceptives (IUD, patch, or pills) with no planned changes during the study
- Body Mass Index (BMI) between 18.5 and less than 30.0 kg/m2 at visit 1
- Willingness to follow all study procedures and provide informed consent
You will not qualify if you...
- Pregnant, planning pregnancy, breastfeeding, or unwilling to use approved contraception during the study
- History or presence of gastrointestinal conditions affecting absorption (e.g., inflammatory bowel syndrome, celiac disease, gastric bypass surgery)
- Significant cardiac, renal, hepatic, endocrine, pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders affecting study adherence or outcomes
- Uncontrolled hypertension (systolic ≥140 mm Hg or diastolic ≥90 mm Hg) unless stable on medication
- Active infection symptoms within 5 days prior to visits
- History of cancer within past 2 years except non-melanoma skin cancer
- Recent major trauma or surgery within 2 months before visit 1
- Planned elective hospitalizations during study
- Recent endoscopy or colonoscopy prep within 3 months before visit 1
- Recent or potential alcohol/substance abuse
- Use of tobacco or nicotine products within 12 months before visit 1
- Habitual marijuana/hemp use without willingness to abstain during study
- Unstable prescription medication use within 90 days before visit 1
- Exposure to non-registered drug products within 30 days before visit 1
- Antibiotic or steroid use within 30 days before visit 1 and during study
- Habitual use of anti-inflammatory medications (≥3 days/week within 1 month before visit 1)
- Use of medications or supplements affecting GI function within 30 days before visit 1 and during study, except standard multivitamins
- Willingness to avoid probiotics, fermented foods, and high-polyphenol foods/supplements during study
- Known allergy or intolerance to study products or excipients
- Any condition interfering with consent, compliance, or study interpretation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants consume 8 oz of cranberry or placebo beverage daily to study its effects on the female microbiome.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
Biofortis
Chicago, Illinois, United States, 60101
Actively Recruiting
Research Team
L
Lindsey Christman, PhD
C
Christina Khoo, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here