Clinical trial NCT05845983: LA Improves the Prognosis of Patients With ICVD
Official title: Lactobacillus Acidophilus Improves the Prognosis (Cognitive Function) of Patients With Ischemic Cerebrovascular Disease After Surgery: a Multicenter, Prospective, Three-blind, Placebo-randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemia
Cerebrovascular Ischemia
Cognitive Impairment
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 236
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ischemic cerebrovascular disease will cause serious harm to the life and safety of patients, and the treatment prognosis is poor. Numerous clinical trials have demonstrated that probiotics can improve cognitive function in people under multimodal. We have previously found that Lactobacillus acidophilus administration could improve cognitive impairment in MCAO and BCAS mice. Therefore, Based on the above research background and the basis of previous studies, we believe that the administration of Lactobacillus acidophilus solid drink (pure Lactobacillus acidophilus strain) can improve the cognitive function of patients with cerebral ischemia through the "brain-gut axis".

Detailed description: Ischemic cerebrovascular disease, as a common form of stroke, is one of the main causes of global morbidity and mortality. The mortality rate of this disease is relatively high, and the treatment prognosis is poor, which will cause serious harm to the life and safety of patients. The optimal treatment for ischemic cerebrovascular disease is still unclear, and the effects of different treatments are still controversial. Therefore, it is of great clinical significance to explore a safe and simple adjuvant treatment method to help patients recover their nervous system function faster and better.

At present, numerous clinical trials have demonstrated that probiotics can improve cognitive function in people under multimodal. Adding intestinal probiotics can improve the intestinal flora distribution, and significantly improve cognitive function in elderly patients with mild cognitive impairment and prevention of brain atrophy. Lactobacillus acidophilus is rich in short chain fatty acids (SCFA). Clinical studies have shown that SCFA levels are negatively correlated with the severity and prognosis of ischemic stroke. Numerous studies have demonstrated that the intestinal supply short chain fatty acids can improve cognitive function, in the middle cerebral artery occlusion (MCAO) induced by acute cerebral ischemia model, rich in the intestines of SCFA can cure acute cerebral ischemia in mice induced by nerve injury. More importantly, in mice with acute cerebral ischemia induced by middle cerebral artery occlusion (MCAO) and chronic cerebral ischemia caused by bilateral common carotid artery stenosis (BCAS), we have previously found that mice have cognitive impairment, accompanied by intestinal flora dysregulation.

Lactobacillus acidophilus administration has a significant effect on improving cognitive function. Based on the above research background and the basis of previous studies, the researchers believe that the administration of Lactobacillus acidophilus solid drink (pure Lactobacillus acidophilus strain) can improve the cognitive function of patients with cerebral ischemia through the "brain-gut axis", and increase the reliability and scope of revascularization, and ultimately improve the prognosis of patients with ischemic cerebrovascular disease.

Eligibility criteria: Inclusion Criteria:

1. Between 35 and 65 years old;
2. Han nationality;
3. Diagnosed as ischemic cerebrovascular disease with mild to moderate symptoms;
4. Can communicate normally, complete neuropsychological tests independently, and sign informed consent;
5. No previous surgical history;
6. No contraindications such as PET, MRI and DSA;
7. No history of stroke identified by imaging;
8. No family history of other chronic diseases, cancer, mental illness or dementia;
9. Improved Rankin scale score ≤2;
10. Ischemic symptoms appeared in the carotid area ≤3 months before the visit;
11. In line with the surgical treatment of ischemic cerebrovascular disease;

Exclusion Criteria:

1. previous dementia;
2. hearing or visual impairment;
3. Drugs that may or are known to influence cognitive abuse;
4. alcohol addiction;
5. Diagnosis of depression, schizophrenia and other psychiatric diseases;
6. MRI showed severe cerebral infarction;
7. Those allergic to Lactobacillus acidophilus;
8. Baseline CT showed intracranial hemorrhage;
9. ischemic onset accompanied by epilepsy;
10. illiteracy;
11. pregnancy or breastfeeding;
12. any serious medical condition that may interact with treatment;

Primary outcomes:
measure: Mini-mental State Examination (MMSE, 0-30) scale
timeFrame: Three months.
measure: Montreal Cognitive Assessment (MoCA, 0-30) scale
timeFrame: Three months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: