Type 1 diabetes
Conditions
Interventions
Treatment group:Lactobacillus gasseri
Control group:Placebo
Sponsors
Jiangnan University
Eligibility
Sex/Gender
All
Age
3 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed by a physician as a patient with Type 1 Diabetes (T1D); 2.Aged 3-60 years, irrespective of gender; 3.Fasting C-peptide > 100 pmol/L [0.30 ng/mL] or random C-peptide > 200 pmol/L [0.60 ng/mL]; 4.Signed informed consent and voluntarily agree to the following procedures: taking probiotics as required, self-monitoring blood glucose, maintaining a daily medication log, completing a patient diary, providing stool and blood samples during the study, and attending study visits. For child/adolescent participants, consent from their legal guardian is required, and the informed consent form must be signed by the guardian.
Exclusion criteria
Exclusion criteria: 1. Type 2 diabetes or other specific types of diabetes; 2. Concurrent autoimmune diseases, liver or kidney diseases, cardiovascular diseases, malignant tumors, acute or chronic inflammation, or psychiatric disorders; 3. Use of other probiotic supplements or products within one month prior to randomization; 4. Use of antibiotics, immunosuppressants, chemotherapy drugs, or other medications that may alter gut microbiota composition within three months prior to randomization; 5. Allergy or intolerance to the components of the probiotic product used in the study; 6. Poor patient compliance or low likelihood of follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum C-peptide;HbA1C; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-glucose monitoring;Insulin requirment;Islet autoantibodies;Lymphocyte subsets in peripheral blood;Serum cytokines;fecal metagenome;fecal metabolome;C-reactive proteinve; | — |
Countries
China
Contacts
Public ContactJia Sun
Jiangnan University
Outcome results
None listed