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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Vaginal Health
• Interventions: Dietary Supplement: Vaginal Probiotic

• Registration Number: NCT06124313
• Lead Sponsor: Rael

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-14
• Study First Submitted: 2023-11-04
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-09
• Primary Completion: 2024-01-14
• Study Completion: 2024-01-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Vaginal Probiotic	Participants will take one capsule of the test product every day, with water.

Primary Outcome Measures

Name	Time	Method
Changes in symptoms of bacterial vaginosis.	Baseline to Week 12	Participants will complete self-reported questionnaires reporting on incidence and severity of symptoms of bacterial vaginosis.
Changes in vaginal odor.	Baseline to Week 12	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.
Changes in vaginal itchiness.	Baseline to Week 12	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.
Changes in vaginal discharge.	Baseline to Week 12	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.
Changes in vaginal dryness.	Baseline to Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).	Baseline to Week 12	The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Changes in scores on the Bristol Stool Chart.	Baseline to Week 12	On the Bristol Stool Chart, stools are assigned a number from 1 to 7, from hardest to loosest. Normal stools are those in the middle of the chart, in the 3 to 4 range

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States