LA Improves the Prognosis of Patients With ICVD

Lactobacillus Acidophilus Improves the Prognosis (Cognitive Function) of Patients With Ischemic Cerebrovascular Disease After Surgery: a Multicenter, Prospective, Three-blind, Placebo-randomized Controlled Study

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".

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemia; Cognitive Impairment; Cerebrovascular Ischemia
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Lactobacillus acidophilus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huaqiu Zhang, PhD; Phone Number: +8613419632963; Email: lyc@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LA treatment group; The patient received conventional treatment and Lactobacillus acidophilus treatment for three months after surgery.	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.
Placebo Comparator: Control group; The patient received conventional treatment and Maltodextrin treatment (placebo) for three months after surgery.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Huaqiu Zhang

Study record dates

Study Major Dates

• Study Start (Anticipated): May 4, 2023
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: TJ-IRB20230304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No