The Effect Cranberry-Based Products on the Female Microbiome

NCT07109713 | Recruiting

• 1 other identifier: Bio-2502
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vaginal Microbiome; Gut Microbiome; Gut Health

Keywords

vaginal microbiome; gut microbiome; cranberry; polyphenols

Outcome Measures

Primary Outcomes (1)

• Vaginal Microbiome

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

  4 weeks

Secondary Outcomes (7)

• Vaginal Microbiome Diversity

  4 weeks

• Vaginal pH

  4 weeks

• GI microbiome

  4 weeks

• Vaginal health questionairre

  4 weeks

• Gastrointestinal Symptom Rating Scale (GSRS)

  4 weeks

Study Arms (2)

Cranberry beverage

ACTIVE COMPARATOR

Participant will receive 8 oz of cranberry beverage to consume each day

Dietary Supplement: Active

Placebo Beverage

PLACEBO COMPARATOR

Participant will receive 8 oz of placebo beverage to consume each day

Dietary Supplement: Placebo

Interventions

Active DIETARY_SUPPLEMENT

Cranberry Beverage

Cranberry beverage

Placebo DIETARY_SUPPLEMENT

Placebo Beverage

Placebo Beverage

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal female,
• 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.

You may not qualify if:

• 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).
• 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.
• 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.
• Exposed to any non-registered drug product within 30 days prior to visit 1.

Sponsors & Collaborators

• Ocean Spray Cranberries, Inc.: lead

Study Sites (1)

Biofortis

Chicago, Illinois, 60101, United States

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elizabeth Antoo, MD

  BioFortis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Christman, PhD

CONTACT

5089467293; lchristman@oceanspray.com

Christina Khoo, PhD

CONTACT

508-946-7925; ckhoo@oceanspray.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 5, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 20, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)