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NCT07165977: CoProM
Anti-inflammatory Probiotics in Cognitive Functioning
NA trial testing Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo in Memory Decline in 110 participants. Participants enrolled and being followed up; not accepting new ones.
30 September 2025
Quick facts
| Lead sponsor | University of Social Sciences and Humanities, Warsaw |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 110 |
| Start date | 25 January 2024 |
| Primary completion | 30 September 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo
- Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)
Conditions studied
- Memory Decline — all drugs for Memory Decline →
- Cognitive Decline — all drugs for Cognitive Decline →
- Cognitive Aging — all drugs for Cognitive Aging →
Sponsor
University of Social Sciences and Humanities, Warsaw
Who can join
50 and older, any sex, with Memory Decline or Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07165977
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07165977 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Social Sciences and Humanities, Warsaw
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07165977.
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