NCT07165977

Anti-inflammatory Probiotics in Cognitive Functioning

The Impact of an Anti-inflammatory Probiotic Supplementation on Cognitive Functioning in the Elderly Population - the Moderating Role of the Dietary Patterns and Gut Microbiota

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Social Sciences and Humanities, Warsaw · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2024-01-25
• Primary completion: 2025-09-30
• Completion: 2026-12-31
• First posted: 2025-09-10
• Last updated: 2025-09-17

Locations

1 site across 1 country: Poland