IschemiaNCT05845983
LA Improves the Prognosis of Patients With ICVD
A study testing Lactobacillus acidophilus and Maltodextrin in people with Ischemia and Cerebrovascular Ischemia, 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 65 years
- Conditions the study is for
- Ischemia, Cerebrovascular Ischemia, Cognitive Impairment
- What is being tested?
- Lactobacillus acidophilus and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2023to 31 Dec 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- 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;
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- 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;
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 Multicenter, Prospective, Three-blind, Placebo-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 Ischemia, Cognitive Impairment
- Being tested
- Lactobacillus acidophilus, Maltodextrin
- Medical subject headings
- Ischemia, 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.
MaltodextrinDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The patient received conventional treatment and Maltodextrin treatment (placebo) for three months after surgery. Receives: Dietary Supplement: Maltodextrin |
| 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 posted6 May 2023
- Study start4 May 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IschemiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845983
- Sponsor's protocol ID
- TJ-IRB20230304
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40812303
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. 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 Multicenter, Prospective, Three-blind, Placebo-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05845983
- Acronym / sponsor ID
- TJ-IRB20230304
- Conditions
- Ischemia, Cerebrovascular Ischemia, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Huaqiu ZhangUniversity, hospital or other
- Study start
- 4 May 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 May 2023 (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
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: MaltodextrinThe patient received conventional treatment and Maltodextrin treatment (placebo) for three months after surgery. |
| 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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
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 |
| MaltodextrinMaltodextrin 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. | Dietary supplement | Control 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 6 May 2023.
- Derived from this study: PubMed 40812303Huang 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.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus acidophilus and Maltodextrin in people with Ischemia and Cerebrovascular Ischemia, 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 11 inclusion and 12 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 6 May 2023. 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. Some participants in this study may receive a placebo. 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 (+8613419632963, lyc@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?
On the ClinicalTrials.gov record for NCT05845983, which also lists 1 linked publication.
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 6 May 2023.