Intervention for Children With Type 1 Diabetes Targeting Gut Microbes (NCT06198725) | Clinical Trial Compass
RecruitingNot Applicable
Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
China110 participantsStarted 2024-01-08
Plain-language 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.
Who can participate
Age range6 Years – 12 Years
SexALL
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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 re…