Anti-inflammatory Probiotics in Cognitive Functioning

NCT07165977 | Active Not Recruiting DMC

• 2 other identifiers: Cognition-Probiotic-Microbiota2021/43/O/HS6/02074
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Memory Decline; Cognitive Decline; Cognitive Aging

Keywords

dietary patterns; probiotic intervention; cognitive functioning; EEG; ERP; gut microbiota; gut brain axis

Outcome Measures

Primary Outcomes (3)

• Change in Differentiation score in California Verbal Learning Test (CVLT) to assess long-term memory

  California Verbal Learning Test (CVLT) measure the verbal learning and memory. It measures how well individuals learn and recall verbal material, assessing both short-term and long-term memory. The Differentiation score measures the ability to distinguish between correct and incorrect responses. Scores range from 0 to 16, with higher scores indicating better outcome.

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

• Change in d' score in old/new recognition test (ONR) to assess long-term memory

  The old/new word recognition task is designed to assess episodic memory. It is consisted of two phases: a learning phase and a recognition phase. During the learning phase, participants viewed 30 pictures on the computer. In the recognition phase, participants were presented with 30 "old" and 30 "new" pictures in random order and were asked to determine whether each picture had been shown during the learning phase. To analyze episodic memory task we followed Macmillan and Creelman (2005) signal detection theory, where d' is the ability to discriminate between signal and noise (between old and new stimuli), H stands for the proportion of correct changes detected (hit rate), and F stands for the proportion of changes incorrectly reported (false alarm rate). d' = zH - zF

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

• Change in N400 event-related potential (ERP) component amplitude to assess long-term memory

  The N400 ERP component will be measured during an old/new word recognition task designed to assess episodic memory. The task involves presenting participants with previously studied ("old") and novel ("new") words while EEG is recorded. The N400 component-typically observed as a negative deflection peaking around 400 ms post-stimulus-is sensitive to familiarity and memory retrieval. A reduced N400 amplitude for old versus new words is interpreted as successful recognition. Changes in N400 amplitude over time will indicate modulation of episodic memory performance across the intervention.

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

Secondary Outcomes (17)

• Changes in Beck Depression Inventory (BDI) total score to assess symptoms of depression

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

• Changes in the Fatigue Assessment Scale (FAS) total score to assess symptoms of chronic fatigue

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

• Change in the number of correctly marked target characters in the d2 Test of Attention (d2-R) - to assess attention.

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

• Change in Concentration score in d2 Test of Attention (d2-R) - to assess attention

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

• Change in Wechsler Adult Intelligence Scale (WAIS) Digit Symbol Substitution subtest total score to assess cognitive processing speed, visual-motor coordination, and sustained attention

  Baseline (prior to intervention), at the end of the 3-month probiotic/placebo supplementation period, and again 3 months after the crossover.

Other Outcomes (4)

• Dietary inflammatory index

  Baseline (prior to intervention)

• Score in Mini-mental state examination (MMSE)

  Baseline (prior to intervention)

• Score in the Raven's Progressive Matrices test

  Baseline (prior to intervention)

Study Arms (4)

Anti-inflammatory diet + probiotic first

EXPERIMENTAL

This is a group of participants whose everyday dietary pattern was assessed as anti-inflammatory based on the Shivappa et al. (2014) equation, and who will receive probiotics during the first 3 months of the study.

Dietary Supplement: Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo

Anti-inflammatory diet + placebo first

EXPERIMENTAL

This is a group of participants whose everyday dietary pattern was assessed as anti-inflammatory based on the Shivappa et al. (2014) equation, and who will receive placebo during the first 3 months of the study.

Dietary Supplement: Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)

Pro-inflammatory diet + probiotic first

EXPERIMENTAL

This is a group of participants whose everyday dietary pattern was assessed as pro-inflammatory based on the Shivappa et al. (2014) equation, and who will receive probiotics during the first 3 months of the study.

Dietary Supplement: Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo

Pro-inflammatory diet + placebo first

EXPERIMENTAL

This is a group of participants whose everyday dietary pattern was assessed as pro-inflammatory based on the Shivappa et al. (2014) equation, and who will receive placebo during the first 3 months of the study.

Dietary Supplement: Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)

Interventions

Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo DIETARY_SUPPLEMENT

Each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for 3 months. * Dosage: One capsule per day, containing 3 × 10⁹ (3 billion) CFU\*. * Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule. After completion of the first phase, each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for another 3 months. * Dosage: One capsule per day. * Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule. * CFU = Colony Forming Units

Anti-inflammatory diet + probiotic first; Pro-inflammatory diet + probiotic first

Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) DIETARY_SUPPLEMENT

Each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for 3 months. * Dosage: One capsule per day. * Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule. After completion of the first phase, each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for another 3 months. * Dosage: One capsule per day, containing 3 × 10⁹ (3 billion) CFU\*. * Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule. * CFU = Colony Forming Units

Anti-inflammatory diet + placebo first; Pro-inflammatory diet + placebo first

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50 or older
• Signed written Informed Consent Form
• Score ≥28 on the Mini-Mental State Examination (MMSE)
• A willingness and motivation to follow the study protocol

You may not qualify if:

• Regular use of prebiotics, antibiotics, or antifungal medications
• Use of prebiotics, antibiotics, or antifungal medications within the past 3 months
• Diagnosed neurological disorder
• History of head injury with neurological consequences
• Left-handedness

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead
• Sanprobi Sp. z o. o.: collaborator
• National Science Centre, Poland: collaborator

Study Sites (1)

SWPS University

Warsaw, Masovian Voivodeship, 03-815, Poland

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Head of the Neurocognitive Research Center at SWPS University

Model Details: Randomized, double-blind, and placebo-controlled study

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: January 25, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)