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Therapeutic effect and mechanism of Lactobacillus rhamnosus Probio-M9 on type 1 diabetes mellitus and related cognitive dysfunction

Therapeutic effect and mechanism of Lactobacillus rhamnosus Probio-M9 on type 1 diabetes mellitus and related cognitive dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062775
Enrollment
Unknown
Registered
2022-08-18
Start date
2022-08-15
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Type 1 Diabetes

Interventions

Latent Autoimmune Diabetes in Adults Group 1:Lactobacillus rhamnosus Probio-M9
Latent Autoimmune Diabetes in Adults Group 2:probiotics
Other immune-mediated diabetes Group 1:Lactobacillus rhamnosus Probio-M9
Other immune-mediated diabetes Group 2:probiotics
Idiopathic type 1 diabetes Group 1: Lactobacillus rhamnosus Probio-M9
Idiopathic type 1 diabetes Group 2:probiotics

Sponsors

Weihai Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis and classification of type 1 diabetes met the clinical diagnosis and classification criteria of American Diabetes Association, which was divided into immune-mediated diabetes (including adult delayed autoimmune diabetes) and idiopathic type 1 diabetes. The study was divided into 3 groups:1.Latent Autoimmune Diabetes in Adults(age >30 years at diagnosis, positive diabetes-related autoantibodies, such as glutamate decarboxylase antibody, and no insulin treatment for at least 6 months after diagnosis); 2.Other immune-mediated diabetes (positive for diabetes-related autoantibodies, such as glutamate decarboxylase antibody);3. Idiopathic type 1 diabetes (permanent insulin reduction, such as C-peptide = 16 years. 3. Agree to participate in this study and sign informed consent. The patient was conscious and able to complete the examination, questionnaire survey and medical history collection by himself or with the help of his family.

Exclusion criteria

Exclusion criteria: 1. Have severe cognitive impairment that affects written and verbal expression; 2. Patients with severe aphasia or dysarthria; 3. Neurological and psychiatric diseases (degenerative and/or vascular dementia, Parkinson's disease, stroke and major depression), severe multiple organ diseases (anemia, lung disease, cancer) and other cognitive diseases; 4. Other serious physical diseases or serious abnormalities of thyroid, liver and kidney function; 5. Patients who needed to take immunosuppressants for a long time or took antibiotics within 1 month before enrollment and during follow-up; 6. During the follow-up period, stop taking medication or adjust the sample at will; 7. During the follow-up period, patients also took defecation promoting drugs, such as polyethylene glycol electrolyte, phenolphthalein tablets, senna leaf, etc. 8. Patients with chronic digestive diseases or tumors, such as gastrointestinal ulcer, inflammatory enteritis, severe liver disease, etc. 9. People who are allergic to the tested samples or show obvious gastrointestinal symptoms, such as being unable to tolerate them.

Design outcomes

Primary

MeasureTime frame
cognitive;Depression;Anxiety;

Countries

China

Contacts

Public ContactJinbiao Zhang

Weihai Municipal Hospital

drzhangjinbiao@163.com+86 18660378456

Outcome results

None listed

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