Vaginal MicrobiomeNCT07109713
The Effect Cranberry-Based Products on the Female Microbiome
A study testing Active in people with Vaginal Microbiome and Gut Microbiome, run by Ocean Spray Cranberries, Inc. at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiome, Gut Microbiome, Gut Health
- What is being tested?
- Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pre-menopausal female,
- 18 - 45 years of age (inclusive) at visit 1.
- History of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior to visit 1. Participants that are using contraceptives (IUD, patch, or pills) must be on a stable dose, defined as no change in medication regimen, within 90 days of visit 1 (or within 6 months of visit 1 for copper IUD users) and no plans to change hormonal contraceptive use during the study.
- BMI ≥18.5 to <30.0 kg/m2 at visit 1.
- Willing to adhere to all study procedures, including lifestyle considerations (see section 6.2), and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Who cannot join
- Women's health related criteria
- •Female who 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.
- General health related criteria
- Participant has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
- History or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit •Stable use of hypertension medication is allowed (defined as no change in medication regimen ≤ 90 d of visit 1).
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- Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment has been completed at least 5 days prior to testing.
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- History of any major trauma or major surgical event within 2 months of visit 1.
- Subject has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
- Underwent an endoscopy or colonoscopy preparation within 3 months prior to visit 1.
- Exclusionary products related criteria
- Recent history of (within 12 months of screening; visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
- Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
- Habitual users (i.e., daily or almost daily) of marijuana and hemp products, including CBD products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed). Occasional use (e.g., couple times a month) within 12 months of visit 1 is allowed but requires at least a 14 d washout prior to visit 1 and the participant must be willing to refrain from use during the study.
- Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days of visit 1. This exclusion criterion does not include hormonal contraceptives.
- Exposed to any non-registered drug product within 30 days prior to visit 1.
- Antibiotic use within 30 d of visit 1 and throughout the study period.
- Steroid use within 30 d of visit 1 and throughout the study period.
- Current habitual user (≥ 3 days/week ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDs, acetaminophen, etc.).
- Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to, pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodic within 30 d of visit 1 and throughout the study period. Standard multivitamin and mineral supplements are allowed.
- Willing to avoid consuming probiotics or fermented foods within 14 d of visit 1 and throughout the study period.
- Willing to avoid consuming high-polyphenol foods and supplements [e.g., dark colored and polyphenol-rich fruits (berries, grapes, pomegranates, cherries, grapefruit, black currant, plum) and their processed food/juice and related supplement products (e.g. grape seed extract, green tea extract); red wine; dark chocolate; cranberry extract supplements] throughout the study period.
- General safety related criteria
- Known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biofortis
Chicago, Illinois, 60101
About this study
Official title: A Randomized, Parallel, Controlled Trial Investigating the Effects a Cranberry-Based Products on the Female Microbiome
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
Read the detailed description
Among various strategies explored to modulate the composition and function of different microbiomes, dietary interventions, like the consumption of cranberry-based products have garnered interest due to their historical use and emerging scientific evidence suggesting beneficial effects on host health. Cranberries are rich in bioactive compounds, notably polyphenols such as proanthocyanidins, which have been investigated for their potential to influence microbial adhesion and growth, especially in the genitourinary tract. While cranberry phenolic compounds generally exhibit poor bioavailability, they have been shown to be metabolized by gut microbiota through fermentation in the distal intestine, yielding bioavailable and bioactive bacteria-derived metabolites. These findings highlight the critical need to understand the potential crosstalk between human microbiome ecosystems and how dietary cranberries might modulate this interaction to impact health outcomes.
- Conditions
- Vaginal Microbiome, Gut Microbiome, Gut Health
- Being tested
- Active, Placebo
- Keywords
- vaginal microbiome, gut microbiome, cranberry, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDietary supplement
Cranberry Beverage
PlaceboDietary supplement
Placebo Beverage
| Study group | Role | What they receive |
|---|---|---|
| Cranberry beverage | Active comparator | Participant will receive 8 oz of cranberry beverage to consume each day Receives: Dietary Supplement: Active |
| Placebo Beverage | Placebo comparator | Participant will receive 8 oz of placebo beverage to consume each day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Microbiome
The number of participants exhibiting a Lactobacillus-dominant CST vaginal microbiome following the 28-day intervention
Measured: 4 weeks
Secondary outcomes (7)
Vaginal Microbiome Diversity
Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)
Measured: 4 weeks
Vaginal pH
vaginal pH
Measured: 4 weeks
GI microbiome
Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)
Measured: 4 weeks
Vaginal health questionairre
Vaginal health visual analog score: itching, dryness, discharge, odor. This is a scale from 0-3 with 3 being the most bothersome score
Measured: 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
GI symptoms are measured using a Gastrointestinal Symptom Rating Scale (GSRS), which ranges from 1 to 7 per item, with higher scores indicating worse gastrointestinal symptoms
Measured: 4 weeks
RAND SF-36 component scores
To assess overall physical and mental health-related quality of life, scores were reported using the RAND 36-Item Health Survey (SF-36), with Physical and Mental Component Summary scores ranging from 0 to 100, where higher scores indicate better health status
Measured: 4 weeks
Bristol Stool Scale score
Stool consistency was measured using the Bristol Stool Form Scale (BSFS), which categorizes stool into seven types ranging from 1 (hard, indicative of constipation) to 7 (liquid, indicative of diarrhea), with types 3 and 4 considered most typical of healthy bowel movements
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start5 Aug 2025
- Primary completion19 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocean Spray Cranberries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Antoo, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109713
- Sponsor's protocol ID
- Bio-2502
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Controlled Trial Investigating the Effects a Cranberry-Based Products on the Female Microbiome
- ClinicalTrials.gov ID
- NCT07109713
- Acronym / sponsor ID
- Bio-2502
- Conditions
- Vaginal Microbiome, Gut Microbiome, Gut Health
- Keywords
- vaginal microbiome, gut microbiome, cranberry, polyphenols
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ocean Spray Cranberries, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Among various strategies explored to modulate the composition and function of different microbiomes, dietary interventions, like the consumption of cranberry-based products have garnered interest due to their historical use and emerging scientific evidence suggesting beneficial effects on host health. Cranberries are rich in bioactive compounds, notably polyphenols such as proanthocyanidins, which have been investigated for their potential to influence microbial adhesion and growth, especially in the genitourinary tract. While cranberry phenolic compounds generally exhibit poor bioavailability, they have been shown to be metabolized by gut microbiota through fermentation in the distal intestine, yielding bioavailable and bioactive bacteria-derived metabolites. These findings highlight the critical need to understand the potential crosstalk between human microbiome ecosystems and how dietary cranberries might modulate this interaction to impact health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry beverage | Active comparator | Dietary Supplement: ActiveParticipant will receive 8 oz of cranberry beverage to consume each day |
| Placebo Beverage | Placebo comparator | Dietary Supplement: PlaceboParticipant will receive 8 oz of placebo beverage to consume each day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pre-menopausal female,
- 18 - 45 years of age (inclusive) at visit 1.
- History of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior to visit 1. Participants that are using contraceptives (IUD, patch, or pills) must be on a stable dose, defined as no change in medication regimen, within 90 days of visit 1 (or within 6 months of visit 1 for copper IUD users) and no plans to change hormonal contraceptive use during the study.
- BMI ≥18.5 to <30.0 kg/m2 at visit 1.
- Willing to adhere to all study procedures, including lifestyle considerations (see section 6.2), and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Key exclusion criteria (26 listed)
- Women's health related criteria
- •Female who 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.
- General health related criteria
- Participant has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
- History or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveCranberry Beverage | Dietary supplement | Cranberry beverage |
| PlaceboPlacebo Beverage | Dietary supplement | Placebo Beverage |
Primary outcome
Vaginal Microbiome
Time frame: 4 weeks
The number of participants exhibiting a Lactobacillus-dominant CST vaginal microbiome following the 28-day intervention
7 secondary outcomes
Vaginal Microbiome Diversity
Time frame: 4 weeks
Vaginal pH
Time frame: 4 weeks
GI microbiome
Time frame: 4 weeks
Vaginal health questionairre
Time frame: 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 4 weeks
RAND SF-36 component scores
Time frame: 4 weeks
Bristol Stool Scale score
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Antoo, MD principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active in people with Vaginal Microbiome and Gut Microbiome, run by Ocean Spray Cranberries, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Christman, PhD (5089467293, lchristman@oceanspray.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Microbiome (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.