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