Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

Recruiting now · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT06198725

Run by

Children's Hospital of Fudan University

People needed

110

Starts

2024-01-08

Expected to finish

2026-12-31

Last updated by the study team

2026-03-17

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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