School of Psychology and Clinical Languages
London, RG6 6UR, United Kingdom
Location contact
Vanessa Sofia Amaral Lopes Simoes
CONTACT
Vanessa Sofia Amaral Lopes Simoes
SUB_INVESTIGATOR
NCT Number: NCT07667530
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.
Trial opening soon.
Get Notified25 year–40 year
All sexes
Interventional
Not applicable
London, RG6 6UR, United Kingdom
Vanessa Sofia Amaral Lopes Simoes
CONTACT
Vanessa Sofia Amaral Lopes Simoes
SUB_INVESTIGATOR
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ecologic® Barrier (1x1010 CFU/day).
Other names: Probiotics
Matched placebo
Other names: placebo
Time frame: Baseline and 16 weeks
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.
Time frame: Baseline, 24 hours, and 16 weeks
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.
Time frame: Screening, baseline, 24 hours, and 16 weeks
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.
Time frame: Baseline, 24 hours, and 16 weeks
A short diagnostic interview designed to screen for 17 psychiatric disorders and the risk of suicide.
Time frame: Baseline, 24 hours, and 16 weeks
A self-report questionnaire measuring the tendency to focus on negative thinking, distressing symptoms, and their causes when people feel down, sad, or depressed.
Time frame: baseline, 24 hours, and 16 weeks
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.
Time frame: Baseline, 24 hours, and 16 weeks
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.
Time frame: baseline, 24 hours, and 16 weeks
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.
Time frame: Baseline, 24 hours, and 16 weeks
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.
Time frame: Every day from baseline to the final 16-week time point.
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.
Time frame: Baseline, 24 hours, and 16 weeks
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.
Time frame: Baseline, 24 hours, and 16 weeks
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.
Time frame: Baseline
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.
Time frame: Baseline and 16 weeks
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.
Time frame: Baseline and 16 weeks
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.
University of Reading
Other
The Acute and Chronic Effects of Ecologic® Barrier on Depressive Symptoms and Neural Activation.
Acronym: PRODAN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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