LA Improves the Prognosis of Patients With ICVD After Surgery

NCT05656209 | Not Yet Recruiting

• 1 other identifier: 13419632963
• Study Type: interventional
• Target: 236
• Locations: 0 countries
• Sites: 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".

Conditions

Ischemia; Cerebrovascular; Cognitive Impairment

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

NO INTERVENTION

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

LA treatment group

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus acidophilus

Interventions

Lactobacillus acidophilus DIETARY_SUPPLEMENT

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.

LA treatment group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old;
• Diagnosed as ischemic cerebrovascular disease, mild to moderate symptoms, can independently complete the neuropsychological test;
• No previous operation history;
• The modified Rankin scale score was 0 or 1;
• Carotid artery ischemic symptoms ≤3 months before treatment;
• Surgical treatment;

You may not qualify if:

• Previous dementia;
• hearing or visual impairment;
• drugs that may or are known to affect cognitive abuse;
• alcohol addiction;
• Diagnosis of depression, schizophrenia and other mental diseases;
• MRI showed severe cerebral infarction;
• Patients with Lactobacillus acidophilus allergy.

Sponsors & Collaborators

• Huaqiu Zhang: lead

MeSH Terms

Conditions

Cerebral Infarction; Cognitive Dysfunction

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Huaqiu Zhang, PhD

  Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Huaqiu Zhang, PhD

CONTACT

13808631221; zhanghq@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: December 19, 2022
• Study Start: December 18, 2022
• Primary Completion: December 18, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share