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Therapeutic effect and mechanism of Bifidobacterium lactis Probio-M8 on post-stroke cognitive impairment

Therapeutic effect and mechanism of Bifidobacterium lactis Probio-M8 on post-stroke cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079870
Enrollment
Unknown
Registered
2024-01-15
Start date
2024-01-16
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Probio-M8 group A:Probio-M8
Placebo group B:Placebo

Sponsors

Weihai Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: 50 years=Age=80 years; 2: Ischemic stroke (NIHSS=18) and supratentorial infarction were diagnosed by computed tomography or magnetic resonance imaging within 1 week of the first onset, which was in line with the 2018 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 3: Patients with acute stroke cognitive impairment (MoCA score < 25) and non-neurodegenerative disease (IQCODE score < 3.19); 4: The patient has clear consciousness and can cooperate with himself or with the help of his family to complete the examination operation, questionnaire survey, history collection, etc; 5: Agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1: Stroke not due to first ischemic stroke, supratentorial infarction, hemorrhagic stroke, trauma, or traumatic surgery 2: Progressive cognitive impairment after stroke (IQCODE score =3.3); 3: Pre-existing conditions such as traumatic brain injury, epilepsy, and severe depression or anxiety may affect cognitive function; 4: Patients had a history of heart diseases such as non-sinus rhythm (atrial fibrillation, atrial flutter, rhythmic rhythm or other arrhythmia), myocardial infarction, heart failure or cardiac pacemaker, which may affect the autonomic nervous system, and other serious comorbidities such as severe lung, liver, kidney diseases or malignant tumors, which may affect the experimental results. 5: People who are unable to complete neuropsychological assessment, such as severe aphasia, visual and physical impairment, or impairment of consciousness that affects written and verbal expression. 6: Patients who need to take immunosuppressants or antibiotics within 1 month before enrollment and during follow-up, or who stop taking or arbitrarily adjust the sample during follow-up, or have taken digoxin, alpha-blockers, beta-blockers, antiarrhythmic drugs, bronchodilators, glucocorticoids and other drugs that may affect the autonomic nervous system in the last 3 months. 7: During the follow-up period, patients also took defecation promoting drugs, such as polyethylene glycol electrolyte, phenolphthalein tablets, senna leaf, etc. 8: Patients with chronic digestive diseases or tumors, such as gastrointestinal ulcer, inflammatory enteritis, severe liver disease, etc. 9: People who are allergic to the tested samples or show obvious gastrointestinal symptoms, such as being unable to tolerate them. 10: people who have irregular dietary habits and large changes during the follow-up period.

Design outcomes

Primary

MeasureTime frame
cognitive;Depression;Anxiety;

Secondary

MeasureTime frame
Stroke severity;

Countries

China

Contacts

Public ContactZhang Jinbiao

Weihai Municipal Hospital

drzhangjinbiao@163.com+86 186 6037 8456

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026