Probiotics for Depressive Symptomatology and Neural Activity. (PRODAN)
19 de junio de 2026 actualizado por: Daniel Lamport, University of Reading
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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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?
Tipo de estudio
Intervencionista
Inscripción (Estimado)
76
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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London, Reino Unido, RG6 6UR
- School of Psychology and Clinical Languages
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Contacto:
- Vanessa Sofia Amaral Lopes Simoes
- Número de teléfono: 0118 987 5123
- Correo electrónico: v.amarallopessimoes@pgr.reading.ac.uk
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Sub-Investigador:
- Vanessa Sofia Amaral Lopes Simoes
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Ecologic® Barrier
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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Ecologic® Barrier (1x1010 CFU/day).
Otros nombres:
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Comparador de placebos: Placebo powder
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. |
Matched placebo
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.
Periodo de tiempo: Baseline and 16 weeks
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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.
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Baseline and 16 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion.
Periodo de tiempo: Baseline, 24 hours, and 16 weeks
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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.
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Baseline, 24 hours, and 16 weeks
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Beck Depression Inventory (BDI-II)
Periodo de tiempo: Screening, baseline, 24 hours, and 16 weeks
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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.
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Screening, baseline, 24 hours, and 16 weeks
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Mini-International Neuropsychiatric Interview (MINI)
Periodo de tiempo: Baseline, 24 hours, and 16 weeks
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A short diagnostic interview designed to screen for 17 psychiatric disorders and the risk of suicide.
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Baseline, 24 hours, and 16 weeks
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Rumination Response Scale (RRS)
Periodo de tiempo: Baseline, 24 hours, and 16 weeks
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A self-report questionnaire measuring the tendency to focus on negative thinking, distressing symptoms, and their causes when people feel down, sad, or depressed.
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Baseline, 24 hours, and 16 weeks
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Neural Activity
Periodo de tiempo: baseline, 24 hours, and 16 weeks
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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
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Task-switching Task
Periodo de tiempo: Baseline, 24 hours, and 16 weeks
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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.
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Baseline, 24 hours, and 16 weeks
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N-back task
Periodo de tiempo: baseline, 24 hours, and 16 weeks
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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.
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baseline, 24 hours, and 16 weeks
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Profile of Mood States short form (POMS-SF)
Periodo de tiempo: Baseline, 24 hours, and 16 weeks
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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.
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Baseline, 24 hours, and 16 weeks
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Visual Analogue Scale (VAS) of Positive and Negative feelings
Periodo de tiempo: Every day from baseline to the final 16-week time point.
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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.
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Every day from baseline to the final 16-week time point.
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Quality of Life (SF12)
Periodo de tiempo: Baseline, 24 hours, and 16 weeks
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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.
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Baseline, 24 hours, and 16 weeks
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Gastrointestinal Symptom Rating Scale (GSRS)
Periodo de tiempo: Baseline, 24 hours, and 16 weeks
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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.
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Baseline, 24 hours, and 16 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Generalised Anxiety Disorder-7 (GAD-7)
Periodo de tiempo: Baseline
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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.
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Baseline
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Menstrual Cycle Data
Periodo de tiempo: Baseline and 16 weeks
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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.
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Baseline and 16 weeks
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Epic-Norfolk Food Frequency Questionnaire (FFQ)
Periodo de tiempo: Baseline and 16 weeks
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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.
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Baseline and 16 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UReading Probiotics Depression
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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