intervention for children with type 1 diabetes targeting gut microbes

Conditions: Type 1 Diabetes

Summary: the goal of this clinical study is to evaluate the effect of nutritional intervention program based on dietary products in the clinical treatment of newly diagnosed children with type 1 diabetes. the main question aims to answer is: whether high fiber diet can protect beta-cell function in children with newly onset type 1 diabetes. participants will take 12 weeks of high fiber diet intervention and beta-cell function and gut microbiota structure will be analyzed.

the purpose of this project is to establish an early adjuvant treatment program for children with type 1 diabetes targeting gut microbiome, and to evaluate the clinical effect and safety of a dietary product to protect the beta-cell function of newly diagnosed type 1 diabetes children and improve blood sugar control. plan to adopt the parallel randomized controlled clinical trial method to select newly-diagnosed type 1 diabetes children, and randomly divide them into usual care group and high fiber diet group at a ratio of 1:1. to comprehensively evaluate the clinical effect and long-term effect of a high fiber dietary intervention product, the changes of beta-cell function, glucose metabolism, and the structure and function of gut microbiota will be compared before and after treatment.

Eligibility criteria:
inclusion criteria: * diagnosed as type 1 diabetes for the first time according to the diagnostic criteria of the american diabetes association (ada) in the past 6 months; * one or more antibodies against gad65, iaa, ia-2, ica, and znt8 are positive; * the daily total dose of insulin per unit weight was less than 0.5 iu/kg/day three days prior to screening; * fasting c-peptide (fcp)\>0.1 nmol/l (0.3ng/ml); * age range from 6 to 12 years old; * have not participated in any other research projects at present; * the guardian signs the informed consent form, the child agrees to the study, and the child over 8 years old signs the informed consent form. exclusion criteria: * suffering from serious chronic and systemic diseases: tumors, immunodeficiency, heart failure, cushing's syndrome, kidney diseases (including nephrotic syndrome, nephritis, glomerulonephritis, kidney stones, etc.), liver diseases (including autoimmune hepatitis, metabolic liver disease, non-alcoholic fatty liver disease, primary sclerosing cholangitis, chronic, persistent hepatitis, etc.), gallbladder diseases (including cholecystitis, gallstones, etc.), etc; * suffering from acute or chronic gastrointestinal diseases such as crohn's disease, ulcerative colitis, gastroesophageal reflux disease, gastrointestinal ulcers, celiac disease, or having defecation three or more times a day in the past week or more, accompanied by watery stools; * blood pressure ≥ 95th percentile of the same gender, age, and height reference; * plasma triglycerides of 9 years and below should be ≥ 1.12mmol/l, and triglycerides of 10 years and above should be ≥ 1.46mmol/l; * used antibiotics within the past month for 3 days or more; * currently suffering from infectious diseases; * have the history of gastrointestinal surgery, surgery to remove appendicitis and hernia; * evidence of pituitary dysfunction; * use drugs other than insulin that can affect blood sugar levels; * chromosomal abnormalities (such as trisomy 21 syndrome, turner syndrome, etc.); * have taken probiotics and probiotic products continuously for more than 3 days within the first month before enrollment; * unable to guarantee sufficient time to participate in this project.

Keywords: type 1 diabetes high fiber diet beta-cell function gut microbiota