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NCT05845983Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 6 May 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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".

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
236 (estimated)
First submitted
26 Apr 2023
Start date
4 May 2023
Primary completion date
31 Dec 2026
Lead sponsor
Huaqiu Zhang
NCT number
NCT05845983

What you commit to

  • Study type: Interventional
  • Planned participants: 236
  • From 4 May 2023 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous dementia;
  • Drugs that may or are known to influence cognitive abuse;

Other illness

  • hearing or visual impairment;
  • Diagnosis of depression, schizophrenia and other psychiatric diseases;
  • Those allergic to Lactobacillus acidophilus;
  • Baseline CT showed intracranial hemorrhage;
  • ischemic onset accompanied by epilepsy;
  • any serious medical condition that may interact with treatment;

Other

  • alcohol addiction;
  • MRI showed severe cerebral infarction;
  • illiteracy;
  • pregnancy or breastfeeding;

Who the study is looking for

  • 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;

Age in the registry: 35 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.