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Набор скоро начнётся NCT06665126

A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.

Без фазы С лечением Bacterial Vaginosis Yeast Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Prebiotic + Probiotic Supplement, Active Placebo Supplement, Excipient Placebo Supplement.
Кому может быть актуально
Состояния в реестре: Bacterial Vaginosis, Yeast Infection. Базовые параметры: от 25 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Triple-Group Randomized Controlled Trial to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.

Обзор

This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.

Вмешательства

  • Пищевая добавка Prebiotic + Probiotic Supplement
    This intervention includes a combination of prebiotics and probiotics designed to promote vaginal and digestive health. The supplement contains Biotin, Lactobacillus acidophilus (as LA-14®), Bifidobacterium lactis (HN019™), Lactobacillus rhamnosus (as HN001™), Lactobacillus crispatus (as CCFM1110™), Lactobacillus gasseri (as HLG13™), Lactobacillus reuteri (as HR7™), Bacillus subtilis (as DE111®), PreforPro®, White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source)
  • Пищевая добавка Active Placebo Supplement
    The active placebo supplement contains similar probiotic strains without the prebiotic component. Ingredients include Biotin, Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus reuteri, Bacillus subtilis, Inulin (from Chicory Root), White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 d
  • Пищевая добавка Excipient Placebo Supplement
    The excipient placebo supplement contains no active ingredients related to prebiotics or probiotics. It includes White Rice Flour, Magnesium Stearate (Vegetable Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.

Первичные конечные точки

  • Change in Vaginal Microbiome [Срок оценки: Baseline, Day 30]
Вторичные конечные точки (2)
  • Change in Perceived Symptoms of Bacterial Vaginosis [Срок оценки: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30]
  • Change in Perceived Symptoms of Yeast Infections [Срок оценки: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30]

Критерии участия

Критерии включения

  • Women
  • Age 25+
  • Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.
  • Suffers from digestive issues, including bloating, gas, or other digestive discomfort.
  • Generally healthy - do not live with any uncontrolled chronic diseases.
  • Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.
  • If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.

Критерии исключения

  • 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 vaginal health.
  • Started any new medications or supplements that target vaginal health in the past 3 months.
  • Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients
  • Women who are pregnant, breastfeeding, or attempting to conceive
  • Unwilling to follow the study protocol
  • Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Citruslabs — Santa Monica

Идентификаторы

NCT: NCT06665126 · 20397

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗