Clinical trial NCT06968299: Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological
Official title: Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological Outcomes: An Open-label Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Functions Perceptual Disturbances
Cognitive Function Abnormal
Sleep
Psychological
Keywords: Probiotics
ExoBDNF
Cognitive functions
Lead sponsor: SunWay Biotech Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective Cognitive Decline Questionnaire (SCD-Q) scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Computerized cognitive test-Go/No go
timeFrame: 8 weeks
measure: Computerized cognitive test-Task-switching
timeFrame: 8 weeks
measure: Computerized cognitive test-Working memory
timeFrame: 8 weeks
measure: Depression Anxiety Stress Scale DASS-21
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: Director, Child and Adolescent Psychiatry, Department of Psychiatry
name: Hsin-An Chang, MD
role: PRINCIPAL_INVESTIGATOR
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