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NCT Number: NCT07667530

Probiotics for Depressive Symptomatology and Neural Activity.

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.

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Key information

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Psychology and Clinical Languages

London, RG6 6UR, United Kingdom

Location contact

Vanessa Sofia Amaral Lopes Simoes

CONTACT

[email protected]

0118 987 5123

Vanessa Sofia Amaral Lopes Simoes

SUB_INVESTIGATOR

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ecologic® Barrier

Dietary Supplement

Ecologic® Barrier (1x1010 CFU/day).

Other names: Probiotics

Placebo Powder

Dietary Supplement

Matched placebo

Other names: placebo

Primary outcomes

  1. Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.

    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.

Secondary outcomes

  1. Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion.

    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.

  2. Beck Depression Inventory (BDI-II)

    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.

  3. Mini-International Neuropsychiatric Interview (MINI)

    Time frame: Baseline, 24 hours, and 16 weeks

    A short diagnostic interview designed to screen for 17 psychiatric disorders and the risk of suicide.

  4. Rumination Response Scale (RRS)

    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.

  5. Neural Activity

    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.

  6. Task-switching Task

    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.

  7. N-back task

    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.

  8. Profile of Mood States short form (POMS-SF)

    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.

  9. Visual Analogue Scale (VAS) of Positive and Negative feelings

    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.

  10. Quality of Life (SF12)

    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.

  11. Gastrointestinal Symptom Rating Scale (GSRS)

    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.

Other outcomes

  1. Generalised Anxiety Disorder-7 (GAD-7)

    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.

  2. Menstrual Cycle Data

    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.

  3. Epic-Norfolk Food Frequency Questionnaire (FFQ)

    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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Winclove Probiotics B.V.

Registry information

Official study title

The Acute and Chronic Effects of Ecologic® Barrier on Depressive Symptoms and Neural Activation.

Acronym: PRODAN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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