Ischemia; CerebrovascularNCT05656209
LA Improves the Prognosis of Patients With ICVD After Surgery
A study testing Lactobacillus acidophilus in people with Ischemia; Cerebrovascular and Cognitive Impairment, run by Huaqiu Zhang.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Ischemia; Cerebrovascular, Cognitive Impairment
- What is being tested?
- Lactobacillus acidophilus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 18 Dec 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 35-60 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;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Lactobacillus Acidophilus Improves the Prognosis (Cognitive Function) of Patients With Ischemic Cerebrovascular Disease After Surgery: a Prospective Randomized Controlled Study
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".
Read the 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.
- Conditions
- Ischemia; Cerebrovascular, Cognitive Impairment
- Being tested
- Lactobacillus acidophilus
- Medical subject headings
- Cerebral Infarction, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilusDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Lactobacillus acidophilus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental State Examination (MMSE, 0-30) scale
Higher scale scores mean better cognitive function.
Measured: Three months.
Montreal Cognitive Assessment (MoCA, 0-30) scale
Higher scale scores mean better cognitive function.
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start18 Dec 2022 (estimated)
- Primary completion18 Dec 2022 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia; CerebrovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huaqiu Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huaqiu Zhang, Tongji Hospital
- Investigators
- Huaqiu Zhang, PhD, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656209
- Sponsor's protocol ID
- 13419632963
- Status last verified
- Dec 2022
- First submitted
- 19 Aug 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Acidophilus Improves the Prognosis (Cognitive Function) of Patients With Ischemic Cerebrovascular Disease After Surgery: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05656209
- Acronym / sponsor ID
- 13419632963
- Conditions
- Ischemia; Cerebrovascular, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Huaqiu ZhangUniversity, hospital or other
- Study start
- 18 Dec 2022 (estimated)
- Primary completion
- 18 Dec 2022 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The patient received conventional care after surgery, with no other interventions. |
| LA treatment group | Experimental | Dietary Supplement: Lactobacillus acidophilusThe patient received conventional treatment and Lactobacillus acidophilus treatment for three months after surgery. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 35-60 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus acidophilusLactobacillus 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. | Dietary supplement | LA treatment group |
Primary outcome
Mini-mental State Examination (MMSE, 0-30) scale
Time frame: Three months.
Higher scale scores mean better cognitive function.
Montreal Cognitive Assessment (MoCA, 0-30) scale
Time frame: Three months.
Higher scale scores mean better cognitive function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huaqiu Zhang, PhD study director
Tongji Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus acidophilus in people with Ischemia; Cerebrovascular and Cognitive Impairment, run by Huaqiu Zhang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaqiu Zhang, PhD (13808631221, zhanghq@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Examination (MMSE, 0-30) scale (time frame: Three months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.