NCT06968299

Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological

Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological Outcomes: An Open-label Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: SunWay Biotech Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This open-label, single-group, pre/post-test clinical study was conducted to investigate whether ExoBDNF probiotic supplementation could improve cognitive ability. It is expected that 40 subjects aged 18 years and above will be recruited, with a target of 30 cases, to take ExoBDNF probiotics for a total of 8 weeks.

Detailed description

Pre-test and post-test were conducted at week 0 and week 9, respectively. The test items included Cognitive Test Battery, SCD-Q Subjective Cognitive Decline Questionnaire, TCQ Cognitive Function Scale, MMSE Mini-Mental Scale, MoCA Montreal Cognitive Assessment Scale, PSQI Pittsburgh Sleep Quality Scale and DASS-21 Depression, Anxiety and Stress Scale, as well as blood biochemical examination and fecal intestinal flora analysis. The subjects were asked to take a capsule containing 1 x 1010 CFU of ExoBDNF probiotics once daily. Subjects are required to maintain a regular lifestyle. After starting the diet, subjects filled out a daily diary that included questions about study product intake, other food intake, bowel movement frequency, stool quality (consistency and color), any medications received, and any unpleasant symptoms such as diarrhea, constipation, vomiting, flatulence, and discomfort. It is expected that this project will help clarify whether supplementation with Pediococcus acidilactici ExoBDNF can help improve cognitive ability, sleep or mental health.

Conditions

• Cognitive Functions Perceptual Disturbances
• Cognitive Function Abnormal
• Sleep
• Psychological

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules	Product ingredients: microcrystalline cellulose, corn starch, SWP-CGPA01 Pediococcus acidilactici powder (1.0 x 10\^10 CFU); Capsule shell composition: HPMC (hydroxypropyl methylcellulose), pure water, titanium dioxide, gelatin.

Timeline

• Start date: 2025-05-20
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-05-13
• Last updated: 2025-11-24

Locations

1 site across 1 country: Taiwan