Clinical Trial

Anti-inflammatory Probiotics in Cognitive Functioning

Study acronym: CoProM
Active, Not Recruiting
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Record status
This record was last updated September 17, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this study is to explore the potential impact of an anti-inflammatory probiotic mixture of psychobiotics including Bifidobacterium longum Rosell®-175 and Lactobacillus helveticus Rosell®-52 on cognitive functions in older adults following either pro-inflammatory or anti-inflammatory diets. According to recent findings, even short-term exposure to foods with pro- or anti-inflammatory properties may lead to corresponding negative or beneficial effects on cognitive functioning . The main questions this study aims to answer are: * How important is the initial dietary pattern for observing possible beneficial effects of probiotic supplementation? (Diet as a potential moderator) * How important is the initial state of the gut microbiota for observing possible beneficial effects of probiotic supplementation? (Microbiota as a potential moderator) * Is it possible to improve or slow down the decline in cognitive functions associated with aging with probiotic supplementation? * Can probiotic supplementation counteract the negative effects of pro-inflammatory dietary patterns? The investigators will compare probiotic to a placebo (a look-alike substance that contains no active ingredients) to determine whether probiotic is effective in enhancing cognitive function. Participants: * Take a probiotic or placebo capsule daily for 3 months * Undergo a crossover after 3 months - those who initially took probiotics will switch to the placebo, and vice versa * Visit SWPS University for screening (T0), baseline assessments before beginning supplementation (T1), and follow-up assessments at 3 months (T2) and 6 months (T3). The T2 visit occurs just before the crossover. * Complete neuropsychological testing, questionnaires, and EEG recordings during the T1, T2, and T3 visits. * Provide stool samples for gut microbiota analysis at the T1, T2, and T3 visits. * Maintain their usual dietary habits throughout the study.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-09.
Trial Details
NCT Number NCT07165977
Lead Sponsor University of Social Sciences and Humanities, Warsaw
Collaborators: Sanprobi Sp. z o. o., National Science Centre, Poland
Conditions Memory Decline, Cognitive Decline, Cognitive Aging
Enrollment 110 participants
Start Date 2024-01-25
Primary Completion 2025-09-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-17