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LA Improves the Prognosis of Patients With ICVD

Primary Purpose

Ischemia, Cerebrovascular Ischemia, Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactobacillus acidophilus
Maltodextrin
Sponsored by
Huaqiu Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Between 35 and 65 years old; Han nationality; Diagnosed as ischemic cerebrovascular disease with mild to moderate symptoms; Can communicate normally, complete neuropsychological tests independently, and sign informed consent; No previous surgical history; No contraindications such as PET, MRI and DSA; No history of stroke identified by imaging; No family history of other chronic diseases, cancer, mental illness or dementia; Improved Rankin scale score ≤2; Ischemic symptoms appeared in the carotid area ≤3 months before the visit; In line with the surgical treatment of ischemic cerebrovascular disease; Exclusion Criteria: previous dementia; hearing or visual impairment; Drugs that may or are known to influence cognitive abuse; alcohol addiction; Diagnosis of depression, schizophrenia and other psychiatric diseases; MRI showed severe cerebral infarction; Those allergic to Lactobacillus acidophilus; Baseline CT showed intracranial hemorrhage; ischemic onset accompanied by epilepsy; illiteracy; pregnancy or breastfeeding; any serious medical condition that may interact with treatment;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control group

    LA treatment group

    Arm Description

    The patient received conventional treatment and Maltodextrin treatment (placebo) for three months after surgery.

    The patient received conventional treatment and Lactobacillus acidophilus treatment for three months after surgery.

    Outcomes

    Primary Outcome Measures

    Mini-mental State Examination (MMSE, 0-30) scale
    Higher scale scores mean better cognitive function.
    Montreal Cognitive Assessment (MoCA, 0-30) scale
    Higher scale scores mean better cognitive function.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2023
    Last Updated
    April 26, 2023
    Sponsor
    Huaqiu Zhang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05845983
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 4, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2026 (Anticipated)
    Study Completion Date
    December 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Huaqiu Zhang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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".
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemia, Cerebrovascular Ischemia, Cognitive Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    236 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    The patient received conventional treatment and Maltodextrin treatment (placebo) for three months after surgery.
    Arm Title
    LA treatment group
    Arm Type
    Experimental
    Arm Description
    The patient received conventional treatment and Lactobacillus acidophilus treatment for three months after surgery.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus acidophilus
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Maltodextrin
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mini-mental State Examination (MMSE, 0-30) scale
    Description
    Higher scale scores mean better cognitive function.
    Time Frame
    Three months.
    Title
    Montreal Cognitive Assessment (MoCA, 0-30) scale
    Description
    Higher scale scores mean better cognitive function.
    Time Frame
    Three months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Between 35 and 65 years old; Han nationality; Diagnosed as ischemic cerebrovascular disease with mild to moderate symptoms; Can communicate normally, complete neuropsychological tests independently, and sign informed consent; No previous surgical history; No contraindications such as PET, MRI and DSA; No history of stroke identified by imaging; No family history of other chronic diseases, cancer, mental illness or dementia; Improved Rankin scale score ≤2; Ischemic symptoms appeared in the carotid area ≤3 months before the visit; In line with the surgical treatment of ischemic cerebrovascular disease; Exclusion Criteria: previous dementia; hearing or visual impairment; Drugs that may or are known to influence cognitive abuse; alcohol addiction; Diagnosis of depression, schizophrenia and other psychiatric diseases; MRI showed severe cerebral infarction; Those allergic to Lactobacillus acidophilus; Baseline CT showed intracranial hemorrhage; ischemic onset accompanied by epilepsy; illiteracy; pregnancy or breastfeeding; any serious medical condition that may interact with treatment;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Huaqiu Zhang, PhD
    Phone
    +8613419632963
    Email
    lyc@tjh.tjmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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