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

Last updated: August 21, 2024
Sponsor: Rael
Overall Status: Completed

Phase

N/A

Condition

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Colic

Treatment

Vaginal Probiotic

Clinical Study ID

NCT06124313
20337
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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

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 thefollowing symptoms:

  • Unusual vaginal discharge ( thin, grayish-white or milky discharge that has astrong, fishy odor)

  • Changes in vaginal odor (i.e. An unpleasant "fishy" odor)

  • Vaginal itching or irritation

  • Discomfort or burning sensation during urination

  1. Self-reported symptoms associated with irritable bowel syndrome (IBS), includingthree 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

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

  2. 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

Exclusion Criteria:

  1. Any pre-existing chronic conditions that would prevent participants from adhering tothe 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 thepast 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

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Vaginal Probiotic
Phase:
Study Start date:
September 14, 2023
Estimated Completion Date:
January 14, 2024

Connect with a study center

  • Citruslabs

    Santa Monica, California 90404
    United States

    Site Not Available

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