NCT06198725Recruiting
Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 27 Dec 2023
- Start date
- 8 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Children's Hospital of Fudan University
- Diseases
- Type 1 diabetes
- NCT number
- NCT06198725
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 8 Jan 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use drugs other than insulin that can affect blood sugar levels;
- Have taken probiotics and probiotic products continuously for more than 3 days within the first month before enrollment;
Other illness
- 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;
- Currently suffering from infectious diseases;
- Have the history of gastrointestinal surgery, surgery to remove appendicitis and hernia;
- Chromosomal abnormalities (such as trisomy 21 syndrome, Turner syndrome, etc.);
Age
- Blood pressure ≥ 95th percentile of the same gender, age, and height reference;
Other
- 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;
- Evidence of pituitary dysfunction;
- Unable to guarantee sufficient time to participate in this project.
Who the study is looking for
- 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.
Age in the registry: 6 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.