Mild-to-moderate DepressionPRODANNCT07667530
Probiotics for Depressive Symptomatology and Neural Activity.
A study testing Ecologic® Barrier in people with Mild-to-moderate Depression and Neural Activity, run by University of Reading at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Mild-to-moderate Depression, Neural Activity, Executive Function (Cognition)
- What is being tested?
- Ecologic® Barrier
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
School of Psychology and Clinical Languages
London, RG6 6UR
Vanessa Sofia Amaral Lopes Simoes, 0118 987 5123, v.amarallopessimoes@pgr.reading.ac.uk
Vanessa Sofia Amaral Lopes Simoes
About this study
Official title: 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.
Read the detailed description
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?
- Being tested
- Ecologic® Barrier, Placebo powder
- Keywords
- Mild-to-moderate Depression, Probiotic Supplementation, Neural Activation, Executive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologic® BarrierDietary supplement
Also called Probiotics
Ecologic® Barrier (1x1010 CFU/day).
Placebo powderDietary supplement
Also called placebo
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ecologic® Barrier |
| 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. Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 16 weeks
Secondary outcomes (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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 24 hours, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild-to-moderate DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomised control trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Winclove Probiotics B.V.
- Responsible party
- Principal investigator, Daniel Lamport, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667530
- Sponsor's protocol ID
- UReading Probiotics Depression
- Acronym
- PRODAN
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute and Chronic Effects of Ecologic® Barrier on Depressive Symptoms and Neural Activation.
- ClinicalTrials.gov ID
- NCT07667530
- Acronym / sponsor ID
- PRODAN / UReading Probiotics Depression
- Keywords
- Mild-to-moderate Depression, Probiotic Supplementation, Neural Activation, Executive Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Winclove Probiotics B.V.
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomised control trial.
| Arm | Type | Receives |
|---|---|---|
| Ecologic® Barrier | Experimental | Dietary Supplement: Ecologic® BarrierParticipants 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. |
| Placebo powder | Placebo comparator | Dietary Supplement: Placebo powderA 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecologic® BarrierAlso: ProbioticsEcologic® Barrier (1x1010 CFU/day). | Dietary supplement | Ecologic® Barrier |
| Placebo powderAlso: placeboMatched placebo | Dietary supplement | Placebo powder |
Primary outcome
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.
11 secondary outcomes
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
Beck Depression Inventory (BDI-II)
Time frame: Screening, baseline, 24 hours, and 16 weeks
Mini-International Neuropsychiatric Interview (MINI)
Time frame: Baseline, 24 hours, and 16 weeks
Rumination Response Scale (RRS)
Time frame: Baseline, 24 hours, and 16 weeks
Neural Activity
Time frame: baseline, 24 hours, and 16 weeks
Task-switching Task
Time frame: Baseline, 24 hours, and 16 weeks
N-back task
Time frame: baseline, 24 hours, and 16 weeks
Profile of Mood States short form (POMS-SF)
Time frame: Baseline, 24 hours, and 16 weeks
Visual Analogue Scale (VAS) of Positive and Negative feelings
Time frame: Every day from baseline to the final 16-week time point.
Quality of Life (SF12)
Time frame: Baseline, 24 hours, and 16 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline, 24 hours, and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
School of Psychology and Clinical Languages
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecologic® Barrier in people with Mild-to-moderate Depression and Neural Activity, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression. (time frame: Baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.