Actively Recruiting
The Effect Cranberry-Based Products on the Female Microbiome
Led by Ocean Spray Cranberries, Inc. · Updated on 2025-08-14
60
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overall objective of this clinical trial is to compare the effects of a cranberry-based product to a placebo-control product on vaginal and GI microbiome outcomes and associated participant reported outcomes in generally healthy pre-menopausal women
CONDITIONS
Official Title
The Effect Cranberry-Based Products on the Female Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-menopausal female
- 18 to 45 years of age at visit 1
- History of regular menstrual cycles (21-35 days per cycle or at investigator's discretion) for at least 3 months prior to visit 1
- Stable use of contraceptives (IUD, patch, or pills) with no changes in medication regimen within 90 days of visit 1 (6 months for copper IUD users) and no plans to change use 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 lifestyle guidelines and provide informed consent
You will not qualify if you...
- Pregnant, planning to become pregnant during the study, lactating, or of childbearing potential not willing to use approved contraception throughout the study
- History or presence of gastrointestinal conditions that could affect absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, prior gastric bypass surgery)
- History or presence of significant cardiac, renal, hepatic, endocrine (including diabetes), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders affecting study adherence or outcomes
- Uncontrolled hypertension (systolic ≥140 mm Hg or diastolic ≥90 mm Hg); stable hypertension medication use allowed
- Active infections of clinical relevance within 5 days prior to any test visit
- History of cancer within 2 years except non-melanoma skin cancer
- Major trauma or surgery within 2 months prior to visit 1
- Planned elective hospitalizations during the study
- Endoscopy or colonoscopy preparation within 3 months prior to visit 1
- Recent or potential alcohol or substance abuse within 12 months of screening
- Use of tobacco or nicotine products within 12 months prior to visit 1
- Habitual daily or almost daily marijuana/hemp use; occasional use allowed with 14-day washout and abstinence during study
- Unstable prescription medication use except hormonal contraceptives
- Exposure to non-registered drug products within 30 days prior to visit 1
- Antibiotic or steroid use within 30 days prior to visit 1 and during study
- Frequent use of anti-inflammatory medications within 1 month prior to visit 1
- Use of medications or supplements affecting GI function within 30 days prior to visit 1 and during study, except standard multivitamins
- Willingness to avoid probiotics, fermented foods, and high-polyphenol foods and supplements during study
- Known allergy or intolerance to study products or excipients
- Any condition interfering with informed consent or study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Biofortis
Chicago, Illinois, United States, 60101
Actively Recruiting
Research Team
L
Lindsey Christman, PhD
CONTACT
C
Christina Khoo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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