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Идёт набор NCT07362251

Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults

Без фазы С лечением Healthy

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: Probiotic.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
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

Evaluation of the Acceptability of a Multi-strain Probiotic Supplement (Smile Probio 45B) in Healthy Adults: an Open-label Pilot Study

Обзор

The goal of this clinical trial is to examine the compliance and acceptability of the probiotic Smile Probio 45B in healthy adults, as well as its effect on gastrointestinal symptoms, fatigue levels, and quality of life. Specifically, the study examines the effect of probiotic intake on improving health-related quality of life, reducing self-reported gastrointestinal symptoms such as bloating, as well as regulating stool consistency and frequency. In addition, its impact on participants' self-reported energy levels is investigated, with a particular emphasis on reducing fatigue symptoms. Participants will: * take 1 capsule daily (with a main meal) during the first and second week of the intervention, and 3 capsules daily (after each main meal) during the third and fourth week of the intervention, for a total duration of 30 days. * complete a three-day food record on a weekly basis. * record their daily bowel habits, including the number of bowel movements and their consistency/form, according to the Bristol Stool Chart, which will be provided to them. * complete questionnaires assessing health-related quality of life \[WHOQOL-BREF (World Health Organization Quality of Life)\],a health status questionnaire \[EQ-5D (EuroQol-5D)\] and a questionnaire evaluating energy levels and fatigue \[Chalder Fatigue Scale (CFQ)\]. * complete, at baseline and at the end of each intervention week a weekly symptom assessment questionnaire. * undergo body composition assessment at the beginning, midpoint, and end of the study. * complete an acceptability questionnaire at the end of the intervention.

Вмешательства

  • Пищевая добавка Probiotic
    Participants will receive probiotic supplement: 1 capsule daily for 2 weeks, followed by 3 capsules daily for 2 weeks.

Первичные конечные точки

  • Daily compliance and stool consistency using the Bristol Stool Form Scale [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Acceptability of the probiotic using an acceptability questionnaire [Срок оценки: Immediately after the intervention]
Вторичные конечные точки (4)
  • Effect of Smile Probio 45B on gastrointestinal symptoms [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Effect of Smile Probio 45B on fatigue levels [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Effect of Smile Probio 45B on quality of life using the EQ-5D-5L questionnaire [Срок оценки: From enrollment to the end of treatment at 4 weeks]
  • Effect of Smile Probio 45B on quality of life using the WHOQOL-BREF questionnaire [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Критерии участия

Критерии включения

  • Men and women aged over 18 years
  • Body Mass Index (BMI) >18 kg/m² and <30 kg/m²
  • No use of antibiotics in the past month
  • Willingness to provide informed consent

Критерии исключения

  • Pregnancy or breastfeeding
  • Age under 18 years
  • Diagnosis of a chronic autoimmune disease (e.g., Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis)
  • Diagnosis of type I or II diabetes
  • Current use of immunosuppressive medications
  • Current use of antibiotics or use of antibiotics within the past month
  • Current use of other supplements such as probiotics, prebiotics, or synbiotics
  • Kidney or liver disease
  • Self-reported allergy to any component of the probiotic
  • Psychological conditions affecting the ability to provide informed consent (e.g., dementia, psychosis, substance use)
  • Gastrointestinal surgery within the last 6 months

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Греция · 1 центр
  • School of Physical Education, Sport Science and Dietetics — Trikala

Идентификаторы

NCT: NCT07362251 · 25 / 28.03.2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗