Status:
COMPLETED
A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
Lead Sponsor:
Rael
Collaborating Sponsors:
Citruslabs
Conditions:
Irritable Bowel Syndrome
Vaginal Health
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.
Eligibility Criteria
Inclusion
- Women aged 18-40
- Self-reported concerns with vaginal odor, itchiness, dryness, or discharge
- Self-reported issues associated with bacterial Vaginosis, reporting three of the following symptoms:
- Unusual vaginal discharge ( thin, grayish-white or milky discharge that has a strong, fishy odor)
- Changes in vaginal odor (i.e. An unpleasant "fishy" odor)
- Vaginal itching or irritation
- Discomfort or burning sensation during urination
- Self-reported symptoms associated with irritable bowel syndrome (IBS), including three of the following symptoms:
- Abdominal pain or discomfort
- Changes in bowel habits i.e. diarrhea, constipation, or a combination of both.
- Bloating
- Gas or flatulence
- Changes in stool appearance
- Mucus in the stool
- Generally healthy - don't live with any uncontrolled chronic diseases
- Willing to avoid the use of any intra-vaginal products (such as vaginal creams, gels, or medications) as well as suppositories during the study product use
Exclusion
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Planning to undergo any procedure related to their reproductive health.
- Started any new medications or supplements that target vaginal health or IBS in the past 3 months.
- Anyone with known severe allergic reactions
- Women who are pregnant, breastfeeding, or attempting to become pregnant
- Unwilling to follow the study protocol
- Anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer
- Anyone who has changed or stopped taking hormonal birth control in the last 3 months
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06124313
Start Date
September 14 2023
End Date
January 14 2024
Last Update
August 23 2024
Active Locations (1)
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1
Citruslabs
Santa Monica, California, United States, 90404