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Probiotics for Depressive Symptomatology and Neural Activity. (PRODAN)

19 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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?

Typ studiów

Interwencyjne

Zapisy (Szacowany)

76

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Suplement diety: Ecologic® Barrier
Ecologic® Barrier (1x1010 CFU/day).
Inne nazwy:
  • Probiotyki
Komparator 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.
Suplement diety: Placebo powder
Matched placebo
Inne nazwy:
  • placebo

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.
Ramy czasowe: 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

Miary wyników drugorzędnych

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Generalised Anxiety Disorder-7 (GAD-7)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Reading

Współpracownicy

Winclove Probiotics B.V.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

19 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

25 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • UReading Probiotics Depression

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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