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

NCT06124313 | Completed

• 1 other identifier: 20337
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Changes in symptoms of bacterial vaginosis.

  Participants will complete self-reported questionnaires reporting on incidence and severity of symptoms of bacterial vaginosis.

  Baseline to Week 12

• Changes in vaginal odor.

  Participants will complete self-reported questionnaires reporting their perceptions of their vaginal odor. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.

  Baseline to Week 12

• Changes in vaginal itchiness.

  Participants will complete self-reported questionnaires reporting the severity of vaginal itching. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.

  Baseline to Week 12

• Changes in vaginal discharge.

  Participants will complete self-reported questionnaires reporting their perceptions of their vaginal discharge. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response.

  Baseline to Week 12

• Changes in vaginal dryness.

  Participants will complete self-reported questionnaires reporting the severity of vaginal dryness. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response.

  Baseline to Week 12

Secondary Outcomes (2)

• Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).

  Baseline to Week 12

• Changes in scores on the Bristol Stool Chart.

  Baseline to Week 12

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Dietary Supplement: Vaginal Probiotic

Interventions

Vaginal Probiotic DIETARY_SUPPLEMENT

This product contains: Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei

Intervention Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rael: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: September 14, 2023
• Primary Completion: January 14, 2024
• Study Completion: January 14, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (1)