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| Name | Class |
|---|---|
| Winclove Probiotics B.V. | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ecologic® Barrier | Experimental | 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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| Placebo powder | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecologic® Barrier | Dietary Supplement | Ecologic® Barrier (1x1010 CFU/day). |
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| Measure | Description | Time Frame |
|---|---|---|
| Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression. | 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. | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Generalised Anxiety Disorder-7 (GAD-7) | 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. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Psychology and Clinical Languages | London | RG6 6UR | United Kingdom |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Double-blind, placebo-controlled, randomised control trial.
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| Placebo powder | Dietary Supplement | Matched placebo |
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| Baseline, 24 hours, and 16 weeks |
| Beck Depression Inventory (BDI-II) | 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. | Screening, baseline, 24 hours, and 16 weeks |
| Mini-International Neuropsychiatric Interview (MINI) | A short diagnostic interview designed to screen for 17 psychiatric disorders and the risk of suicide. | Baseline, 24 hours, and 16 weeks |
| Rumination Response Scale (RRS) | A self-report questionnaire measuring the tendency to focus on negative thinking, distressing symptoms, and their causes when people feel down, sad, or depressed. | Baseline, 24 hours, and 16 weeks |
| Neural Activity | 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 |
| Task-switching Task | 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. | Baseline, 24 hours, and 16 weeks |
| N-back task | 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. | baseline, 24 hours, and 16 weeks |
| Profile of Mood States short form (POMS-SF) | 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. | Baseline, 24 hours, and 16 weeks |
| Visual Analogue Scale (VAS) of Positive and Negative feelings | 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. | Every day from baseline to the final 16-week time point. |
| Quality of Life (SF12) | 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. | Baseline, 24 hours, and 16 weeks |
| Gastrointestinal Symptom Rating Scale (GSRS) | 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. | Baseline, 24 hours, and 16 weeks |
| Menstrual Cycle Data | 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. | Baseline and 16 weeks |
| Epic-Norfolk Food Frequency Questionnaire (FFQ) | 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. | Baseline and 16 weeks |
| D019602 |
| Food and Beverages |