Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorChildren's Hospital of Fudan University
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Trimtab
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Children's Hospital of Fudan University
Lead sponsor
Adfontes (Shanghai) Bio-technology Co.,Ltd.
Collaborator
Source ClinicalTrials.gov