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

• Sponsor: Rael (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06124313
• Collaborator: Citruslabs (Industry)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IBS; Vaginal Health	Dietary Supplement: Vaginal Probiotic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Single Group Study to Evaluate the Effects of a Vaginal Probiotic on Vaginal and Digestive Health
• Actual Study Start Date: Sep 14, 2023
• Anticipated Primary Completion Date: Jan 14, 2024
• Anticipated Study Completion Date: Jan 14, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Participants will take one capsule of the test product every day, with water.	Dietary Supplement: Vaginal Probiotic; This product contains: Probiotic Blend 15B CFU, 5 Strains (56mg) Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Women aged 18-40

2. Self-reported concerns with vaginal odor, itchiness, dryness, or discharge

3. Self-reported issues 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

1. Self-reported symptoms associated with 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

1. Generally healthy - don't live with any uncontrolled chronic diseases

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

• Rael
• Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rael
• ClinicalTrials.gov Identifier: NCT06124313
• Other Study ID Numbers: 20337
• First Posted: Nov 9, 2023
• Last Update Posted: Nov 9, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 9, 2023