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Therapeutic effect and mechanism of bifidobacterium lactis m8 in patients with type 2 diabete-related cognitive dysfunction

Therapeutic effect and mechanism of bifidobacterium lactis m8 in patients with type 2 diabete-related cognitive dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048643
Enrollment
Unknown
Registered
2021-07-12
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

Group 2:Bifidobacterium lactis M8
Group 4:Bifidobacterium lactis M8

Sponsors

Weihai Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: Part 1: 1.The diagnosis of T2DM meets the clinical diagnostic criteria of the ADA; 2.aMCI meets Peterson's diagnostic criteria for aMCI; 3.50-85 years old; 4.MoCA score < 26, Clinical Dementia Scale score 0.5, Hachinski Ischemia Index scale <=4, Hamilton17 <=12; 5.Agree to participate in the study and sign the informed consent; 6.The patient has clear consciousness and can complete the examination operation, questionnaire survey and medical history collection by himself or with the help of his family. Part 2: 1.The patient has clear consciousness and can complete the examination operation, questionnaire survey and medical history collection by himself or with the help of his family; 2.Non-neurodegenerative diseases (IQCODE score < 3.19); 3.First ischemic stroke (NIHSS < 17), in line with the 2018 Chinese Acute Ischemic Stroke Diagnosis and Treatment Guidelines; 4.The diagnosis of T2DM meets the clinical diagnostic criteria of the ADA; 5.Agree to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: first part: 1. Neurological and psychiatric diseases (degenerative and/or vascular dementia, Parkinson's disease, stroke and major depression), severe multi-organ diseases (anemia, lung disease, cancer) and other diseases that affect cognition; 2. Other serious physical diseases or thyroid, heart, lung, liver, kidney diseases or other serious comorbidities that may affect the experimental results; 3. Patients who need to take immunosuppressive drugs for a long time or take antibiotics within 1 month before enrollment and take antibiotics during the follow-up period; 4. Those who stopped taking or adjusted the test samples at will during the follow-up period; 5. Patients taking defecation-promoting drugs, such as polyethylene glycol electrolytes, phenolphthalein tablets, and senna leaves, at the same time during the follow-up period; 6. Patients with chronic digestive system diseases or tumors, such as peptic ulcer, inflammatory bowel disease, severe liver disease, etc.; 7. Those who are allergic to the test sample or have obvious gastrointestinal symptoms such as intolerance; 8. Patients with irregular eating habits and great changes during the follow-up period. the second part: 1. Stroke caused by hemorrhagic stroke, trauma or traumatic surgery; 2. Progressive cognitive impairment before stroke (IQCODE score >=3.3); 3. Other heart, lung, liver, kidney diseases or other serious comorbidities that may affect the experimental results; 4. Patients who need to take immunosuppressive drugs for a long time or take antibiotics within 1 month before enrollment and take antibiotics during the follow-up period; 5. Those who stopped taking or adjusted the test samples at will during the follow-up period; 6. Patients taking defecation-promoting drugs, such as polyethylene glycol electrolytes, phenolphthalein tablets, and senna leaves at the same time during the follow-up period; 7. Patients with chronic digestive system diseases or tumors, such as peptic ulcer, inflammatory bowel disease, severe liver disease, etc.; 8. Those who are allergic to the test sample or have obvious gastrointestinal symptoms such as intolerance; 9. Patients with irregular eating habits and large changes during the follow-up period.

Design outcomes

Primary

MeasureTime frame
cognitive;Depression;Anxiety;

Countries

China

Contacts

Public ContactZhang Jinbiao

Weihai Municipal Hospital

drzhangjinbiao@163.com+86 18660378456

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026