Probiotics for Depressive Symptomatology and Neural Activity. (PRODAN)
19 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
76
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
London, Reino Unido, RG6 6UR
- School of Psychology and Clinical Languages
-
Contato:
- Vanessa Sofia Amaral Lopes Simoes
- Número de telefone: 0118 987 5123
- E-mail: v.amarallopessimoes@pgr.reading.ac.uk
-
Subinvestigador:
- Vanessa Sofia Amaral Lopes Simoes
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
Ecologic® Barrier (1x1010 CFU/day).
Outros nomes:
|
|
Comparador de Placebo: 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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.
Prazo: 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.
|
Baseline and 16 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion.
Prazo: 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.
|
Baseline, 24 hours, and 16 weeks
|
|
Beck Depression Inventory (BDI-II)
Prazo: 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.
|
Screening, baseline, 24 hours, and 16 weeks
|
|
Mini-International Neuropsychiatric Interview (MINI)
Prazo: Baseline, 24 hours, and 16 weeks
|
A short diagnostic interview designed to screen for 17 psychiatric disorders and the risk of suicide.
|
Baseline, 24 hours, and 16 weeks
|
|
Rumination Response Scale (RRS)
Prazo: 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.
|
Baseline, 24 hours, and 16 weeks
|
|
Neural Activity
Prazo: 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. |
baseline, 24 hours, and 16 weeks
|
|
Task-switching Task
Prazo: 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.
|
Baseline, 24 hours, and 16 weeks
|
|
N-back task
Prazo: 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.
|
baseline, 24 hours, and 16 weeks
|
|
Profile of Mood States short form (POMS-SF)
Prazo: 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.
|
Baseline, 24 hours, and 16 weeks
|
|
Visual Analogue Scale (VAS) of Positive and Negative feelings
Prazo: 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.
|
Every day from baseline to the final 16-week time point.
|
|
Quality of Life (SF12)
Prazo: 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.
|
Baseline, 24 hours, and 16 weeks
|
|
Gastrointestinal Symptom Rating Scale (GSRS)
Prazo: 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.
|
Baseline, 24 hours, and 16 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Generalised Anxiety Disorder-7 (GAD-7)
Prazo: 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.
|
Baseline
|
|
Menstrual Cycle Data
Prazo: 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.
|
Baseline and 16 weeks
|
|
Epic-Norfolk Food Frequency Questionnaire (FFQ)
Prazo: 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.
|
Baseline and 16 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
1 de março de 2027
Conclusão do estudo (Estimado)
1 de março de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
19 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de junho de 2026
Primeira postagem (Real)
25 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UReading Probiotics Depression
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .