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Search / Trial NCT06968299

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

Launched by SUNWAY BIOTECH CO., LTD. · May 5, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Probiotics Exo Bdnf Cognitive Functions

ClinConnect Summary

This clinical trial is studying whether taking a specific probiotic supplement called ExoBDNF can help improve cognitive functions, sleep, and psychological well-being in adults aged 18 and older. Researchers want to find out if this probiotic can enhance thinking abilities and overall mental health. They plan to recruit around 40 participants to take the supplement for 8 weeks.

To participate, individuals must be mentally clear and able to communicate, and they need to voluntarily agree to join the study by signing a consent form. However, certain people will not be eligible, including those who are pregnant, have specific medical conditions like heart disease or severe gastrointestinal issues, or those with significant hearing or vision problems. If someone has had a major brain injury or certain neurological issues, they also won't be able to participate. This study is not yet recruiting, but it aims to provide valuable insights into how probiotics might benefit cognitive health.

Gender

ALL

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.

About Sunway Biotech Co., Ltd.

Sunway Biotech Co., Ltd. is a leading biotechnology company dedicated to advancing innovative therapeutics and diagnostic solutions. With a focus on research and development, Sunway Biotech aims to address unmet medical needs through the discovery and commercialization of cutting-edge biopharmaceutical products. The company is committed to adhering to the highest standards of clinical research and regulatory compliance, ensuring the safety and efficacy of its offerings. By fostering collaboration with academic institutions and industry partners, Sunway Biotech is poised to make significant contributions to the healthcare landscape, driving forward the frontiers of medical science.

Locations

Taipei City, , Taiwan

Patients applied

0 patients applied

Trial Officials

Hsin-An Chang, MD

Principal Investigator

Director, Child and Adolescent Psychiatry, Department of Psychiatry

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported