Clinical trial NCT06124313: A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
Official title: A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Vaginal Health
Lead sponsor: Rael
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Changes in symptoms of bacterial vaginosis.
timeFrame: Baseline to Week 12
measure: Changes in vaginal odor.
timeFrame: Baseline to Week 12
measure: Changes in vaginal itchiness.
timeFrame: Baseline to Week 12
measure: Changes in vaginal discharge.
timeFrame: Baseline to Week 12
measure: Changes in vaginal dryness.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).
timeFrame: Baseline to Week 12
measure: Changes in scores on the Bristol Stool Chart.
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: