A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome, Vaginal Health

In brief

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.

Key facts

Study ID

NCT06124313

Run by

Rael

People needed

40

Starts

2023-09-14

Expected to finish

2024-01-14

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Citruslabs — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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