immune-related endocrine diseases
Conditions
Interventions
FMT Capsule treatment group:FMT Capsule treatment
Health Control:None
Sponsors
Sir Run Run Hospital, Nanjing Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: A total of 1000 patients with immunorelated endocrine diseases were collected, including type 1 diabetes (including LADA), type 2 diabetes, autoimmune thyroid diseases (including chronic lymphocytic thyroiditis, subacute lymphocytic thyroiditis, Graves' disease), Addsion disease, etc. There were 300 cases of type 1 diabetes, 500 cases of type 2 diabetes, 150 cases of autoimmune thyroid disease and 50 cases of other immune-related endocrine diseases. At the same time, 200 healthy people were recruited. Donor Inclusion Criteria: 1. Willingness to complete the questionnaire-based screening process. 2. Healthy children and adults under 60 years of age, with preference for individuals aged 6–24 years. 3. Normal body mass index (18–24 kg/m²) and regular bowel habits. Inclusion Criteria for Healthy Individuals: 1. Non-pregnant individuals with a healthy lifestyle and good dietary habits. 2. No use of antibiotics or medications that cause intestinal microecological disturbances in the past 3 months. 3. No chronic diseases such as constipation, irritable bowel syndrome, inflammatory bowel disease (IBD), autoimmune diseases, immunosuppressive states, or a history of malignancy. 4. Negative results for infectious disease tests (e.g., hepatitis B, hepatitis C, syphilis, HIV/AIDS). 5. Negative stool examination results for pathogens such as *Clostridioides difficile*, dysenteric bacilli, *Shigella*, *Campylobacter*, and parasites.
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients with immune-related endocrine diseases: 1. Systemic use of glucocorticoids, other immunosuppressive agents, biological immunomodulators, antibiotics, probiotics, or other microecological preparations within 3 months prior to enrollment. 2. Active infections (including human immunodeficiency virus (HIV), hepatitis B and C virus infections, or a positive tuberculin test). 3. Complication with irritable bowel syndrome, inflammatory bowel disease, celiac disease, or other chronic gastrointestinal disorders that are uncontrolled. 4. Gastrointestinal involvement in chronic systemic autoimmune diseases. 5. High risk of gastrointestinal malignancy or polyposis. 6. Recent episodes of diarrhea or hematochezia. 7. Pregnant or lactating women, as well as men and women of childbearing age who are unwilling to adopt reliable contraception methods during the study and efficacy observation period. 8. Individuals suffering from psychiatric disorders and refusing intestinal microecological treatment. Exclusion Criteria for Donor: 1. Medication History - Use of antibiotics, antifungals, antivirals, probiotics, or laxatives within the past 3 months. - Administration of immunosuppressive drugs (e.g., calcineurin inhibitors, biologics, exogenous glucocorticoids) within the past 6 months. - Continuous use of proton pump inhibitors for more than 1 month. 2. Disease History - History of infectious diseases (e.g., HIV, hepatitis B or C virus, syphilis, human T-lymphotropic viruses I and II, malaria, trypanosomiasis, tuberculosis). - Gastrointestinal disorders (e.g., altered bowel habits, polyposis). - Systemic immune diseases or atopic conditions (e.g., asthma, eczema, gastrointestinal eosinophilic diseases). - Metabolic syndrome, obesity, or moderate-to-severe malnutrition. - Chronic pain syndromes (e.g., chronic fatigue syndrome, fibromyalgia). - Neurological or neurodevelopmental disorders. - History of malignant diseases. - Psychological disorders. 3. Family History - Three or more first- or second-degree relatives with a history of gastrointestinal neoplasms. - Three or more first- or second-degree relatives with autoimmune or metabolic diseases. - Active gastrointestinal infections in family members. 4. Sexual Behavior - High-risk sexual behavior, including but not limited to: sex work, sexual contact with unknown individuals, sexual contact with individuals who are drug users, HIV-positive, viral hepatitis carriers, or syphilis patients, or a history of sexually transmitted diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting Blood Glucose, FBG;Postprandial Blood Glucose, PBG;HbA1c;insulin dose;C peptide;Self-Monitoring of Blood Glucose, SMBG;Continuous Glucose Monitoring System, CGMS; | — |
Secondary
| Measure | Time frame |
|---|---|
| islet autoantibodies;exophthalmos;Clinical Activity Score;goiter;thyroid function;thyroid autoantibodies;routine urine test;immunology related indicators;trace element;vitamin;renal function;liver function;lipid profile;body mass index; | — |
Countries
China
Contacts
Public ContactLiu Yu
Sir Run Run Hospital, Nanjing Medical University
Outcome results
None listed