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

August 21, 2024 updated by: Rael
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).
Time Frame: 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.
Baseline to Week 12
Changes in scores on the Bristol Stool Chart.
Time Frame: 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
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rael

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Actual)

January 14, 2024

Study Completion (Actual)

January 14, 2024

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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