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

Not Applicable

Not yet recruiting

• Conditions: Cognitive Functions Perceptual Disturbances; Cognitive Function Abnormal; Sleep; Psychological

• Registration Number: NCT06968299
• Lead Sponsor: SunWay Biotech Co., LTD.

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-05
• Last Update Submitted: 2025-05-05
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-05-19
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Subjects must be volunteers who are 18 years of age or older, mentally clear and able to communicate.
2. Subjects who agree to participate in this trial and voluntarily sign the trial consent form.

Exclusion Criteria

1. Subjects who are expected to be or have been confirmed to be pregnant (medical history).
2. Subjects with gallbladder disease, gastrointestinal disease, gout, porphyria, or a history of gastric weight control surgery.
3. Subjects with high blood pressure (≥160/100 mmHg after resting for 10 minutes) or taking diuretics.
4. Subjects with heart disease, hepatorenal insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumors, or any other disease that may affect the results of the study.
5. Subjects with severe hearing or visual impairment that makes it impossible to perform examinations and assessments.
6. Subjects with any history of brain surgery, penetrating, neurovascular, infectious or other severe brain injury, epilepsy or other major neurological abnormalities, such as traumatic brain injury with loss of consciousness for more than 24 hours, or memory loss after head trauma for more than 7 days were excluded.
7. Subjects with intellectual disabilities.
8. Subjects who had consumed probiotics or were expected to consume probiotics within 2 weeks before the screening visit.
9. Subjects who had participated in or were expected to participate in clinical trials within 4 weeks before the screening visit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Subjective Cognitive Decline Questionnaire (SCD-Q) scale	8 weeks	To compare whether there is a statistically significant difference in the Subjective Cognitive Decline Questionnaire (SCD-Q) scale scores between the trial group and the placebo group after taking the probiotics for 8 weeks compared with the values 8 weeks ago (baseline).

Secondary Outcome Measures

Name	Time	Method
Computerized cognitive test-Go/No go	8 weeks	Mainly used to assess concentration, reaction and memory, this task is used to measure the brain's ability to distinguish relevant and irrelevant information. The task requires participants to pay attention to the prompt and judge whether the subsequent stimulus is the target.
Computerized cognitive test-Task-switching	8 weeks	Mainly used to assess the brain's task switching ability, the task switching task is used to measure the flexibility of selective attention. The task requires participants to switch their attention between judging the cardinality of even numbers or the size of numbers.
Computerized cognitive test-Working memory	8 weeks	Mainly used to assess memory, this working memory task refers to the spatial span task (Corsi block tapping task), which is used to measure spatial short-term memory capacity.
Depression Anxiety Stress Scale DASS-21	8 weeks	The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Pittsburgh Sleep Quality Index (PSQI)	8 weeks	The Pittsburgh Sleep Quality Index (PSQI) is a self-assessment questionnaire that assesses sleep quality and sleep disturbances over a one-month period.

Trial Locations

Locations (1)

Tri-Service General Hospital, National Defense Medical Center; 🇨🇳 Taipei city, Taiwan