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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06124313
• Other study ID #: 20337
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: January 14, 2024

Study information

• Verified date: November 2023
• Source: Rael
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 14, 2024
• Est. primary completion date: January 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Vaginal Health

Intervention

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

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Rael	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).	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.	Baseline to Week 12
Secondary	Changes in scores on the Bristol Stool Chart.	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	Baseline to Week 12