Probiotics for Depressive Symptomatology and Neural Activity.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-40
SponsorUniversity of Reading
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Ecologic® Barrier
Dietary supplementEcologic® Barrier (1x1010 CFU/day).
Placebo powder
Dietary supplementMatched placebo
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Ecologic® BarrierExperimental treatment 1 intervention
Group B: Placebo powderPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 16 weeksSecondary 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.
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 weeks2
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.
Time frame
Screening, baseline, 24 hours, and 16 weeks3
Mini-International Neuropsychiatric Interview (MINI)
A short diagnostic interview designed to screen for 17 psychiatric disorders and the risk of suicide.
Time frame
Baseline, 24 hours, and 16 weeks4
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.
Time frame
Baseline, 24 hours, and 16 weeksOther outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline and 16 weeks3
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.
Time frame
Baseline and 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Reading
Lead sponsor
Winclove Probiotics B.V.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: