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OpenTrials
Completed

NCT Number: NCT06124313

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Vaginal Health

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-40
  • Self-reported concerns with vaginal odor, itchiness, dryness, or discharge
  • 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
  • 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
  • Generally healthy - don't live with any uncontrolled chronic diseases
  • 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

  • Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
  • Planning to undergo any procedure related to their reproductive health.
  • Started any new medications or supplements that target vaginal health or IBS in the past 3 months.
  • Anyone with known severe allergic reactions
  • Women who are pregnant, breastfeeding, or attempting to become pregnant
  • Unwilling to follow the study protocol
  • Anyone with a history of vaginal, cervical, vulvar, uterine, or ovarian cancer
  • Anyone who has changed or stopped taking hormonal birth control in the last 3 months

Treatment and study plan

Vaginal Probiotic

Dietary Supplement

This product contains:

Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Rael

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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