Probiotics in Functional Dyspepsia
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: Lactobacillus, Maltodextrin (Placebo).
- Кому может быть актуально
- Состояния в реестре: Functional Dyspepsia. Базовые параметры: 18 лет — 65 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
- Список центров уточняется — проверьте первичный протокол.
- 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
The Effect of Multi-strain Probiotic Formulation on Gastrointestinal Symptoms, Quality of Life and Mental Health in Patients With Functional Dyspepsia: a Randomized Dietary Trial
Обзор
The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are: * Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation? * Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia. Participants will: * Take one capsule of the probiotic or placebo once daily before meals for 60 days * Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months * Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months * Attend scheduled study visits for checkups and assessments
Вмешательства
- Другое Lactobacillus
5 billion CFU of lactobacilus ans streptococci once daily for 60 days - Другое Maltodextrin (Placebo)
Placebo capsules will be given one a day for 60 days
Первичные конечные точки
- Change in Gastrointestinal Symptom Rating Scale [Срок оценки: 30 and 60 days]
Критерии участия
Критерии включения
- Age 18-65 years
- Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:
- Postprandial fullness
- Early satiation
- Epigastric pain or burning
- (with no evidence of structural disease explaining symptoms)
- Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)
- Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)
- Negative for H. pylori (either previously treated successfully or tested negative within study screening)
- Ability and willingness to provide informed consent and comply with study procedures
- Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)
Критерии исключения
- Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy
- History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)
- Positive test for H. pylori during screening (or untreated known infection)
- Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol
- Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment
- Overlap with other functional GI disorders (except IBS) if they are the dominant complaint, unless your protocol allows overlap
- Clinically significant psychiatric illness (e.g., major depression, schizophrenia) that may interfere with symptom reporting or adherence
- Severe systemic or metabolic disease (e.g., uncontrolled diabetes, renal or hepatic failure)
- Pregnancy or lactation, or intention to become pregnant during the study period
- Participation in another clinical trial within the past 3 months
- Known allergy or intolerance to study product components
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
- Поддерживающая терапия
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07276009 · MS-GIT-FD-A0004