Probiotics for Depressive Symptomatology and Neural Activity.
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: Ecologic® Barrier, Placebo powder.
- Кому может быть актуально
- Состояния в реестре: Mild-to-moderate Depression, Neural Activity, Executive Function (Cognition). Базовые параметры: 25 лет — 40 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
- Великобритания
- 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 Acute and Chronic Effects of Ecologic® Barrier on Depressive Symptoms and Neural Activation.
Обзор
This study aims to investigate the acute and chronic effects of 16-week probiotic supplementation (Ecologic® Barrier) on depressive symptoms and neural activity in those with mild-to-moderate depression.
Подробное описание
This study will use a randomised, double-blind, placebo-controlled design. A total of 76 participants will be recruited and will receive either one sachet of the probiotic (Ecologic® Barrier) or one sachet of a placebo, matched in taste, smell, appearance, and packaging. Outcomes will be measured at baseline, 24 hours, and at 16 weeks for all participants. These include measures of general mood, depressive symptoms, executive function, and neural activity. Neural activation will be measured using electroencephalography (EEG), specifically measuring the P300 event-related potential (ERP) during an n-back task. In addition to the n-back task, executive function, specifically working memory and cognitive flexibility will be tested using the task-switching task.
The main question this study aims to answer is:
* Does probiotic supplementation result in improvements in the primary outcome measure of vulnerability and sensitivity to depression, as well as secondary measures of rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion? * Does probiotic supplementation improve accuracy and response times in executive function and working memory, measured by the Task Switching Task (TST) and n-back task? * Is probiotic supplementation associated with an increased P300 amplitude and shorter P300 latency compared to baseline measures during the n-back task, in parietal and frontal lobe regions, with more pronounced effects in the 2-back task? * Is probiotic supplementation associated with changes in alpha and theta band activity and symmetry, particularly after completing a demanding working-memory task?
Вмешательства
- Пищевая добавка Ecologic® Barrier
Ecologic® Barrier (1x1010 CFU/day). - Пищевая добавка Placebo powder
Matched placebo
Первичные конечные точки
- Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression. [Срок оценки: Baseline and 16 weeks]
Вторичные конечные точки (11)
- Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion. [Срок оценки: Baseline, 24 hours, and 16 weeks]
- Beck Depression Inventory (BDI-II) [Срок оценки: Screening, baseline, 24 hours, and 16 weeks]
- Mini-International Neuropsychiatric Interview (MINI) [Срок оценки: Baseline, 24 hours, and 16 weeks]
- Rumination Response Scale (RRS) [Срок оценки: Baseline, 24 hours, and 16 weeks]
- Neural Activity [Срок оценки: baseline, 24 hours, and 16 weeks]
- Task-switching Task [Срок оценки: Baseline, 24 hours, and 16 weeks]
- N-back task [Срок оценки: baseline, 24 hours, and 16 weeks]
- Profile of Mood States short form (POMS-SF) [Срок оценки: Baseline, 24 hours, and 16 weeks]
- Visual Analogue Scale (VAS) of Positive and Negative feelings [Срок оценки: Every day from baseline to the final 16-week time point.]
- Quality of Life (SF12) [Срок оценки: Baseline, 24 hours, and 16 weeks]
- Gastrointestinal Symptom Rating Scale (GSRS) [Срок оценки: Baseline, 24 hours, and 16 weeks]
Критерии участия
Критерии включения
- Mild to moderate depression symptoms (BDI-II 12-28)
- Males and females
- Age range will be 25-40 years
- Right-handed participants only (required for EEG)
Критерии исключения
- Taking antidepressants (up to 2 months prior to inclusion)
- Undergoing psychological treatment in the form of counselling, therapy or similar (up to 1 month prior to inclusion)
- Any diagnosed chronic medical condition (e.g. diabetes) or psychiatric illness.
- Use of antibiotics or laxatives (up to 3 months prior to inclusion)
- Use of probiotics and/or prebiotics (up to 1 month prior to inclusion)
- Enrolled in any other clinical trial (up to 1 month prior to inclusion)
- Following restrictive and/or unbalanced diets
- Smoking
- Continuous use of a weight-loss medication for more than one month prior to screening
- Significant gastrointestinal conditions affecting absorption, including but not limited to: inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end-stage renal disease; active cancer or cancer treatment within the past three years
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
Великобритания · 1 центр
- School of Psychology and Clinical Languages — London
Идентификаторы
NCT: NCT07667530 · UReading Probiotics Depression