Anti-inflammatory Probiotics in Cognitive Functioning

Last updated: September 11, 2025
Sponsor: University of Social Sciences and Humanities, Warsaw
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Memory Problems

Alzheimer's Disease

Treatment

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

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

Clinical Study ID

NCT07165977
Cognition-Probiotic-Microbiota
2021/43/O/HS6/02074
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)
Phase:
Study Start date:
January 25, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • SWPS University

    Warsaw 756135, Masovian Voivodeship 858787 03-815
    Poland

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.