NCT05859230 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hori T, Matsuda K, Oishi K
Probiotics: A Dietary Factor to Modulate the Gut Microbiome, Host Immune System, and Gut-Brain Interaction. Microorganisms. 2020 Sep 11;8(9):1401. doi: 10.3390/microorganisms8091401.
Kailasapathy K, Chin J
Survival and therapeutic potential of probiotic organisms with reference to Lactobacillus acidophilus and Bifidobacterium spp. Immunol Cell Biol. 2000 Feb;78(1):80-8. doi: 10.1046/j.1440-1711.2000.00886.x.
Khine WWT, Voong ML, Ng TKS, Feng L, Rane GA, Kumar AP, Kua EH, Mahendran R, Mahendran R, Lee YK
Mental awareness improved mild cognitive impairment and modulated gut microbiome. Aging (Albany NY). 2020 Dec 9;12(23):24371-24393. doi: 10.18632/aging.202277. Epub 2020 Dec 9.

A Study of a Probiotic (Lacticaseibacillus Paracasei Strain Shirota) Intervention on Gut Microbiota and Cognitive Functioning in Older Adults With Mild Cognitive Impairment

Details for clinical trial NCT05859230

Clinical trial NCT05859230 - References