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

• Registration Number: NCT06124313
• Lead Sponsor: Rael

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Women aged 18-40<br><br> 2. Self-reported concerns with vaginal odor, itchiness, dryness, or discharge<br><br> 3. Self-reported issues associated with bacterial Vaginosis, reporting three of the<br> following symptoms:<br><br> - Unusual vaginal discharge ( thin, grayish-white or milky discharge that has a<br> strong, fishy odor)<br><br> - Changes in vaginal odor (i.e. An unpleasant fishy odor)<br><br> - Vaginal itching or irritation<br><br> - Discomfort or burning sensation during urination<br><br> 4. Self-reported symptoms associated with irritable bowel syndrome (IBS), including<br> three of the following symptoms:<br><br> - Abdominal pain or discomfort<br><br> - Changes in bowel habits i.e. diarrhea, constipation, or a combination of both.<br><br> - Bloating<br><br> - Gas or flatulence<br><br> - Changes in stool appearance<br><br> - Mucus in the stool<br><br> 5. Generally healthy - don't live with any uncontrolled chronic diseases<br><br> 6. Willing to avoid the use of any intra-vaginal products (such as vaginal creams,<br> gels, or medications) as well as suppositories during the study product use<br><br>Exclusion Criteria:<br><br> 1. Any pre-existing chronic conditions that would prevent participants from adhering to<br> the protocol, including oncological and psychiatric disorders<br><br> 2. Planning to undergo any procedure related to their reproductive health.<br><br> 3. Started any new medications or supplements that target vaginal health or IBS in the<br> past 3 months.<br><br> 4. Anyone with known severe allergic reactions<br><br> 5. Women who are pregnant, breastfeeding, or attempting to become pregnant<br><br> 6. Unwilling to follow the study protocol<br><br> 7. Anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer<br><br> 8. Anyone who has changed or stopped taking hormonal birth control in the last 3 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in symptoms of bacterial vaginosis.;Changes in vaginal odor.;Changes in vaginal itchiness.;Changes in vaginal discharge.;Changes in vaginal dryness.

Secondary Outcome Measures

Name	Time	Method
Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS).;Changes in scores on the Bristol Stool Chart.