Probiotics for Depressive Symptomatology and Neural Activity. (PRODAN)
2026年6月19日 更新者：Daniel Lamport、University of Reading
The Acute and Chronic Effects of Ecologic® Barrier on Depressive Symptoms and Neural Activation.
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.
研究概览
详细说明
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?
研究类型
介入性
注册 (估计的)
76
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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London、英国、RG6 6UR
- School of Psychology and Clinical Languages
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接触：
- Vanessa Sofia Amaral Lopes Simoes
- 电话号码：0118 987 5123
- 邮箱：v.amarallopessimoes@pgr.reading.ac.uk
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副研究员：
- Vanessa Sofia Amaral Lopes Simoes
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Ecologic® Barrier
Participants will consume one sachet of Ecologic® Barrier powder(1x10^10 CFU/day), mixed in warm water with a meal.
The sachets can be stored at room temperature.
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Ecologic® Barrier (1x1010 CFU/day).
其他名称：
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安慰剂比较：Placebo powder
A placebo matched for packaging, visual appearance, smell, and taste will be given. Similar to the instructions on how to take the probiotic, subjects will consume one sachet per day, kept at room temperature, mixed into warm water with a meal. |
Matched placebo
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.
大体时间：Baseline and 16 weeks
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A standardised measure of cognitive reactivity.
This questionnaire consists of 34 items, in which participants rate on a scale from 0 to 4, how strongly they feel each statement relates to them when they feel somewhat sad.
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Baseline and 16 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion.
大体时间：Baseline, 24 hours, and 16 weeks
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A standardised measure of cognitive reactivity.
This questionnaire consists of 34 items, in which participants rate on a scale from 0 to 4, how strongly they feel each statement relates to them when they feel somewhat sad.
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Baseline, 24 hours, and 16 weeks
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Beck Depression Inventory (BDI-II)
大体时间：Screening, baseline, 24 hours, and 16 weeks
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A robust tool consisting of 21 items used to measure the severity of depression.
It focuses on symptoms experienced in the last 2 weeks, such as cognitive and affective symptoms.
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Screening, baseline, 24 hours, and 16 weeks
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Mini-International Neuropsychiatric Interview (MINI)
大体时间：Baseline, 24 hours, and 16 weeks
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A short diagnostic interview designed to screen for 17 psychiatric disorders and the risk of suicide.
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Baseline, 24 hours, and 16 weeks
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Rumination Response Scale (RRS)
大体时间：Baseline, 24 hours, and 16 weeks
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A self-report questionnaire measuring the tendency to focus on negative thinking, distressing symptoms, and their causes when people feel down, sad, or depressed.
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Baseline, 24 hours, and 16 weeks
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Neural Activity
大体时间：baseline, 24 hours, and 16 weeks
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P300 event-related potential (ERP) amplitude and latency during the n-back task. Resting-state and active-state alpha and theta power oscillations. An exploratory measure of the N2 ERP may be analysed alongside the P300. |
baseline, 24 hours, and 16 weeks
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Task-switching Task
大体时间：Baseline, 24 hours, and 16 weeks
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This is a measure of executive function and sustained attention.
Participants will be shown a circle with 8 equally spaced radii, 2 of which form a bold bisecting line.
Numbers are chosen randomly from a set of 1-4 & 6-9 and displayed sequentially in a clockwise direction.
A response of higher or lower than 5 is made for trials below the line, and a response of even or odd for numbers above the line.
Accuracy and reaction time (RT) on correct trials, as well as accuracy and RT on trials where there is a 'switch cost' from stimuli moving from below to above the bold line and vice versa, are the main outcome measures.
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Baseline, 24 hours, and 16 weeks
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N-back task
大体时间：baseline, 24 hours, and 16 weeks
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This is an executive function and working memory task.
There are varying difficulties of this task, but this trial will use the 0-back and 2-back versions.
The 0-back task involves participants being shown a sequence of letters and having to respond when the current letter matches that of the previous letter.
In the 2-back task, participants will have to respond when the current letter matches the letter from two trials ago.
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baseline, 24 hours, and 16 weeks
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Profile of Mood States short form (POMS-SF)
大体时间：Baseline, 24 hours, and 16 weeks
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This is a condensed self-report questionnaire used to measure changes in mood, assessed across 6 sub-scales (tension-anxiety, depression-dejection, anger-hostility, vigour-activity, fatigue-inertia, and confusion-bewilderment) with 40 total items.
A total mood disturbance score is provided.
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Baseline, 24 hours, and 16 weeks
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Visual Analogue Scale (VAS) of Positive and Negative feelings
大体时间：Every day from baseline to the final 16-week time point.
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Visual Analogue Scale of positive/negative feelings via a daily assessment.
This includes two questions asking participants to rate on a scale from 0 to 100 the extent to which they felt positive or negative feelings.
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Every day from baseline to the final 16-week time point.
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Quality of Life (SF12)
大体时间：Baseline, 24 hours, and 16 weeks
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The Quality of Life (SF12) is a questionnaire which asks for participants' views about their health.
This information keeps track of how they feel and how well they can do their usual activities.
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Baseline, 24 hours, and 16 weeks
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Gastrointestinal Symptom Rating Scale (GSRS)
大体时间：Baseline, 24 hours, and 16 weeks
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This is a 15-item self-reported questionnaire assessing the severity of gastrointestinal symptoms.
It uses a 7-point Likert scale, covering five symptom domains: reflux, abdominal pain, indigestion, diarrhoea, and constipation symptoms.
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Baseline, 24 hours, and 16 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Generalised Anxiety Disorder-7 (GAD-7)
大体时间：Baseline
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This is a self-report questionnaire used to measure the severity of generalised anxiety disorder.
It has seven items and asks individuals to rate the frequency of anxiety symptoms over the past two weeks, with scores ranging from 0 to 21 to determine anxiety levels.
Baseline scores may be used as a covariate.
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Baseline
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Menstrual Cycle Data
大体时间：Baseline and 16 weeks
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Information regarding the first day of the most recent menstruation, regularity and contraception will be recorded.
It is not a direct outcome measure, but data may be used as a covariate.
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Baseline and 16 weeks
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Epic-Norfolk Food Frequency Questionnaire (FFQ)
大体时间：Baseline and 16 weeks
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This is a validated tool for analysing the average habitual dietary intake of micro and macronutrients of an individual in the UK, which is particularly important to explore in order to understand how the probiotic supplement may interact with diet and gut microbiome diversity.
Data will be processed using the FETA software.
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Baseline and 16 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年6月19日
首先提交符合 QC 标准的
2026年6月19日
首次发布 (实际的)
2026年6月25日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月19日
最后验证
2026年6月1日
更多信息
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