ExoBDNF probiotic to help thinking, sleep, and mood

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-group pre/post-test study will enroll about 30 adults who will take a capsule containing 1 x 10^10 CFU of Pediococcus acidilactici ExoBDNF once daily for 8 weeks. Cognitive function, subjective cognitive complaints, sleep quality, and symptoms of depression/anxiety/stress will be measured at baseline and after treatment using standardized scales (MMSE, MoCA, PSQI, DASS-21, and others). Blood tests and fecal microbiome analyses will be performed before and after supplementation, and participants will keep a daily diary of product intake, diet, bowel habits, and any symptoms. The protocol requires participants to maintain a regular lifestyle during the intervention to limit other influences on outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tri-Service General Hospital, National Defense Medical Center
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Hsin-An Chang, MD — Director, Child and Adolescent Psychiatry, Department of Psychiatry
• Study coordinator: Sean Lin
• Email: sean.lin@sunway.cc
• Phone: 02-27929568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.