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Probiotics for Depressive Symptomatology and Neural Activity. (PRODAN)

2026年6月19日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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?

研究の種類

介入

入学 (推定)

76

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
      • London、イギリス、RG6 6UR
        • School of Psychology and Clinical Languages
        • コンタクト：
        • 副調査官：
          • Vanessa Sofia Amaral Lopes Simoes

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
ダイエットサプリメント：Ecologic® Barrier
Ecologic® Barrier (1x1010 CFU/day).
他の名前：
  • プロバイオティクス
プラセボコンパレーター：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.
ダイエットサプリメント：Placebo powder
Matched placebo
他の名前：
  • プラセボ

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion.
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Generalised Anxiety Disorder-7 (GAD-7)
時間枠：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
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Reading

協力者

Winclove Probiotics B.V.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年3月1日

研究の完了 (推定)

2027年3月1日

試験登録日

最初に提出

2026年6月19日

QC基準を満たした最初の提出物

2026年6月19日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月25日

QC基準を満たした最後の更新が送信されました

2026年6月19日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • UReading Probiotics Depression

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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