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CompletedNo phase

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

Key facts

Who runs it
Rael
Where
Santa Monica, United StatesSee the site
Trial code
Status
Completed
People taking part
40 people enrolled
Started
14 Sept 2023
Ended
14 Jan 2024
Type of study
Interventional
Treatments tested
  • Vaginal Probiotic
Record updated
23 August 2024

Who can take part

Age
18 years to 40 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

  • CitruslabsSanta Monica, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Intervention GroupTreatment being tested

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

    Treatment: Vaginal Probiotic

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
23 August 2024