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

NCT ID: NCT06124313

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-14
• Study Completion Date: 2024-01-14

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.

Conditions

Irritable Bowel Syndrome; Vaginal Health

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Vaginal Probiotic

Intervention Type: DIETARY_SUPPLEMENT

This product contains:

Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei

Interventions

Vaginal Probiotic

This product contains:

Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Rael

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20337

Identifier Type: -

Identifier Source: org_study_id