LA Improves the Prognosis of Patients With ICVD After Surgery

Sponsor
Huaqiu Zhang (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05656209
Collaborator
(none)
236
2
60.4

Study Details

Study Description

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".

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Lactobacillus acidophilus
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
236 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lactobacillus Acidophilus Improves the Prognosis (Cognitive Function) of Patients With Ischemic Cerebrovascular Disease After Surgery: a Prospective Randomized Controlled Study
Anticipated Study Start Date :
Dec 18, 2022
Anticipated Primary Completion Date :
Dec 18, 2022
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

The patient received conventional care after surgery, with no other interventions.

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.

Outcome Measures

Primary Outcome Measures

  1. Mini-mental State Examination (MMSE, 0-30) scale [Three months.]

    Higher scale scores mean better cognitive function.

  2. Montreal Cognitive Assessment (MoCA, 0-30) scale [Three months.]

    Higher scale scores mean better cognitive function.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 35-60 years old;

  2. Diagnosed as ischemic cerebrovascular disease, mild to moderate symptoms, can independently complete the neuropsychological test;

  3. No previous operation history;

  4. The modified Rankin scale score was 0 or 1;

  5. Carotid artery ischemic symptoms ≤3 months before treatment;

  6. Surgical treatment;

Exclusion Criteria:
  1. Previous dementia;

  2. hearing or visual impairment;

  3. drugs that may or are known to affect cognitive abuse;

  4. alcohol addiction;

  5. Diagnosis of depression, schizophrenia and other mental diseases;

  6. MRI showed severe cerebral infarction;

  7. Patients with Lactobacillus acidophilus allergy.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Huaqiu Zhang

Investigators

  • Study Director: Huaqiu Zhang, PhD, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huaqiu Zhang, Professor, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT05656209
Other Study ID Numbers:
  • 13419632963
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2022