Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological
Recruiting
N/AInterventional Study
Cognitive Functions Perceptual DisturbancesCognitive Function AbnormalSleepPsychological
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
SunWay Biotech Co., LTD. · Industry
Who this trial is looking for
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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.
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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 confirme…
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.
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