Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT06146504
Eligibility Criteria:
Inclusion Criteria:
1. Aged between 18-50.
2. Female.
3. Self-reported recurrent vaginal issues, including:
* Itching and irritation in and around the vaginal area.
* Burning sensation during urination or sexual intercourse.
* Abnormal discharge (e.g. thicker, white, and curd-like in appearance, odorless, or with a mild yeasty smell.
* Redness and swelling of the vulva and surrounding skin
* Pain or discomfort in the vaginal area or lower abdomen.
* Urinary tract infections
* Vaginal thrush
4. May also experience issues with fatigue, lethargy, and gut or digestive issues.
5. Willing to provide two stool samples during the study.
6. Willing to adhere to the study protocol.
7. Willing to avoid introducing any products or any new forms of regular medication or supplements that target candida overgrowth, gut health, or vaginal health for the duration of the study.
Exclusion Criteria:
1. Anyone with severe chronic conditions including oncological conditions, psychiatric disease, diabetes, or other.
2. Anyone with known severe allergic reactions or is allergic to the test product or placebo ingredients.
3. Currently taking any antibiotics or will be during the trial period.
4. Anymore diagnosed with a sexually transmitted disease within the last three months e.g. Chlamydia, trichomoniasis, gonorrhea, genital herpes
5. Women who are pregnant, breastfeeding, or attempting to become pregnant.
6. Having any planned invasive medical procedures during the study period.
7. Currently participating in any other clinical study.
8. History of substance abuse.
9. Unwilling to follow the study protocol.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06146504
Study Brief:
Protocol Section:
NCT06146504