autoimmune endocrine diseases
Conditions
Interventions
Experimental group of T1D:oral formula probiotics
Control group of T1D:oral placebo
Experimental group of HT:oral formula probiotics
Control group of HT:oral placebo
Sponsors
The Affiliated Sir Run Run Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 75 Years
Inclusion criteria
Inclusion criteria: This study recruit 180 patients with definitive diagnosis of autoimmune endocrine diseases within 3 years, including 60 patients with type 1 diabetes (including LADA), 120 patients with Hashimoto's thyroiditis (thyroid function is normal). The course of diseases are less than 1 year and the patients aged between 8 and 75 years old.
Exclusion criteria
Exclusion criteria: 1. Systemic application of glucocorticoids, other immunosuppressive drugs or biological immunomodulators, antibiotics, probiotics and other microecological preparations within 6 months prior to enrollment; 2. Active infection (including human immunodeficiency virus (HIV), hepatitis B and hepatitis C virus infection or tuberculin test positive); 3. combined with irritable bowel syndrome, inflammatory bowel disease, celiac disease and other chronic gastrointestinal diseases, the condition failed to control; 4. Chronic systemic autoimmune disease gastrointestinal involvement; 5. High risk of gastrointestinal cancer or polyposis; 6. recent diarrhea, blood in the stool; 7. Pregnant and lactating women, as well as women and men who participate in research and observation period are reluctant to adopt reliable contraceptive methods; 8. suffering from mental diseases or unwilling to accept intestinal microflora treatment. 9.The course of diseases are more than 1 year; 10. Age less than 8 years old or older than 75 years old.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI;blood lipid;FBG;PBG;HbA1c;TPOAb;TgAb; | — |
Secondary
| Measure | Time frame |
|---|---|
| liver function;insulin;C-peptide;islet autoantibodies;thyroid function; | — |
Countries
China
Contacts
Public ContactLiu Yu
The Affiliated Sir Run Run Hospital of Nanjing Medical University
Outcome results
None listed