LA Improves the Prognosis of Patients With ICVD

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05845983
• Other study ID #: TJ-IRB20230304
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2023
• Source: Tongji Hospital
• Contact: Huaqiu Zhang, PhD
• Phone: +8613419632963
• Email: lyc[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cognitive Impairment
• Ischemia

Intervention

Dietary Supplement:
• Lactobacillus acidophilus
Lactobacillus acidophilus solid drink (pure bacteria, food grade, JYLA-191, Shandong Zhongke Jia-yi Biological Engineering Co., LTD.), 3g (containing 2*10^10CFU), twice a day, once in the morning and once in the evening, 1 bag each time, by drinking water, direct oral intake, 1 month/course, continuous use for three courses.
• Maltodextrin
Maltodextrin solid drink (food grade, MD20, Shandong Zhongke Jia-yi Biological Engineering Co., LTD.), 3g, twice a day, once in the morning and once in the evening, 1 bag each time, by drinking water, direct oral intake, 1 month/course, continuous use for three courses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huaqiu Zhang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-mental State Examination (MMSE, 0-30) scale	Higher scale scores mean better cognitive function.	Three months.
Primary	Montreal Cognitive Assessment (MoCA, 0-30) scale	Higher scale scores mean better cognitive function.	Three months.