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
1 other identifier
interventional
236
0 countries
N/A
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedStudy Start
First participant enrolled
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 6, 2023
April 1, 2023
3.7 years
April 26, 2023
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Study Arms (2)
Control group
PLACEBO COMPARATORThe patient received conventional treatment and Maltodextrin treatment (placebo) for three months after surgery.
LA treatment group
EXPERIMENTALThe patient received conventional treatment and Lactobacillus acidophilus treatment for three months after surgery.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huaqiu Zhanglead
Related Publications (1)
Huang Y, Zhang X, Yu C, Liu Y, Kang H, Liu Y, Ni Y, Xia Y, Jiang Z, Chen J, Zhao K, Han L, Zou X, Wang J, Lei T, Gan C, Zhang H. Lactobacillus acidophilus promotes cognitive function recovery via regulating microglial peroxisomal function in cerebral ischemia. Cell Host Microbe. 2025 Sep 10;33(9):1484-1501.e12. doi: 10.1016/j.chom.2025.07.018. Epub 2025 Aug 13.
PMID: 40812303DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 26, 2023
First Posted
May 6, 2023
Study Start
May 4, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
May 6, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share