Probiotics for Depressive Symptomatology and Neural Activity. (PRODAN)
2026년 6월 19일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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?
연구 유형
중재적
등록 (추정된)
76
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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London, 영국, RG6 6UR
- School of Psychology and Clinical Languages
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연락하다:
- Vanessa Sofia Amaral Lopes Simoes
- 전화번호: 0118 987 5123
- 이메일: v.amarallopessimoes@pgr.reading.ac.uk
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부수사관:
- Vanessa Sofia Amaral Lopes Simoes
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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).
다른 이름들:
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위약 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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.
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Generalised Anxiety Disorder-7 (GAD-7)
기간: 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
기간: 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)
기간: 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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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 3월 1일
연구 완료 (추정된)
2027년 3월 1일
연구 등록 날짜
최초 제출
2026년 6월 19일
QC 기준을 충족하는 최초 제출
2026년 6월 19일
처음 게시됨 (실제)
2026년 6월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 19일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UReading Probiotics Depression
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아니요
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