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Cranberry-Based Products Effects on Female Microbiome

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What is being tested

Active

+ Placebo
Dietary Supplement
Who is being recruted

Vaginal Microbiome

+ Gut Microbiome
+ Gut Health
From 18 to 45 Years
+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorOcean Spray Cranberries, Inc.
Study ContactLindsey Christman, PhD
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 5, 2025Actual date on which the first participant was enrolled.

This study explores how different cranberry-based products may affect the microbiome, specifically in women. The microbiome is the community of microorganisms living in our bodies, and it plays a crucial role in health. Cranberries are known for their beneficial compounds, such as proanthocyanidins, which might help maintain a healthy balance of these microorganisms. This research is important as it could offer new dietary strategies to support women's health by influencing the microbiome in a positive way, particularly in the genitourinary tract. Participants in the study will consume various cranberry products, and researchers will monitor any changes in their microbiome. The products will be given in ways that are easy to consume, such as drinks or capsules. Researchers will evaluate if and how these cranberry products impact the growth and behavior of microorganisms in the body. This study does not specify any risks or direct benefits, but its findings could lead to better dietary recommendations for managing microbiome health.

Official TitleA Randomized, Parallel, Controlled Trial Investigating the Effects a Cranberry-Based Products on the Female Microbiome 
Principal SponsorOcean Spray Cranberries, Inc.
Study ContactLindsey Christman, PhD
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 45 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Vaginal Microbiome
Gut Microbiome
Gut Health
Criteria
5 inclusion criteria required to participate
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

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26 exclusion criteria prevent from participating
omen'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
eneral 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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Active Comparator
Participant will receive 8 oz of cranberry beverage to consume each day
Group II
Placebo
Participant will receive 8 oz of placebo beverage to consume each day
Study Objectives
Primary Objectives

The number of participants exhibiting a Lactobacillus-dominant CST vaginal microbiome following the 28-day intervention
Secondary Objectives

Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)

vaginal pH

Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)

Vaginal health visual analog score: itching, dryness, discharge, odor. This is a scale from 0-3 with 3 being the most bothersome score

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

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
BiofortisChicago, United StatesSee the location
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One Study Center