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NCT05859230
Probiotic Intervention on Gut Microbiota and Cognitive Functioning in Older Adults With a Mild Cognitive Impairment
NA trial testing Experimental: The probiotic drink study group in Mild Cognitive Impairment in 50 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | National University of Singapore |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 50 |
| Start date | 5 August 2022 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Experimental: The probiotic drink study group
- Placebo Comparator: The placebo drink study group
Conditions studied
- Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
Sponsor
National University of Singapore
Who can join
Adults 60 to 90, any sex, with Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Recent studies suggest that gut microbiota is linked to cognitive performance and modulating gut microbiota is a safe and promising approach to enhance cognition. The limited studies in the area of probiotics for cognitive impairment in early stages warrant further research. In this feasibility study, we will examine the effects of probiotic consumption in older adults with mild cognitive impairment (MCI), on gut microbiota and cognition via microbiota composition, inflammatory, immune, and bacterial metabolite mechanisms, using neuropsychological tests. The single probiotic contains the Lacticaseibacillus paracasei strain Shirota (LcS), with proven efficacy in various health conditions as well as in stress, sleep, and mood disorders; but to our knowledge, it has not been rigorously examined in early stages of cognitive impairment. After 12 weeks of the randomized, double-blinded probiotic/placebo intervention, we hypothesize that the changes in the composition of gut microbiota, short-chain fatty acids, and the inflammatory/immunological markers, could improve functional connectivity and cognition.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pattern recognition receptors: function, regulation and therapeutic potential.
Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1
Verify or expand the search:
- PubMed search for NCT05859230
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT05859230 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University of Singapore
- Last refreshed: 15 May 2023
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/NCT05859230.
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