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New treatment option for Vaginal Microbiome
Official title The Effect Cranberry-Based Products on the Female Microbiome
ClinicalTrials.gov ID: NCT07109713
What this study is testing
- What it's testing
- 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
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- Women's health related criteria Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential...
- Participant has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g...
- History or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary...
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at...
- 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...
- History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
See the full eligibility criteria
Who can 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.