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

Rael

Status: Completed

Conditions: Irritable Bowel Syndrome; Vaginal Health

Treatments: Dietary Supplement: Vaginal Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06124313

20337

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Women aged 18-40

2. Self-reported concerns with vaginal odor, itchiness, dryness, or discharge

3. 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

4. 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

5. Generally healthy - don't live with any uncontrolled chronic diseases

6. 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 criteria

1. Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
2. Planning to undergo any procedure related to their reproductive health.
3. Started any new medications or supplements that target vaginal health or IBS in the past 3 months.
4. Anyone with known severe allergic reactions
5. Women who are pregnant, breastfeeding, or attempting to become pregnant
6. Unwilling to follow the study protocol
7. Anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer
8. Anyone who has changed or stopped taking hormonal birth control in the last 3 months

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intervention Group

Experimental group

Description:

Participants will take one capsule of the test product every day, with water.

Treatment:

Dietary Supplement: Vaginal Probiotic