Actively Recruiting
Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
Led by Children's Hospital of Fudan University · Updated on 2026-03-17
110
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Fudan University
Lead Sponsor
A
Adfontes (Shanghai) Bio-technology Co.,Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 1 diabetes for the first time within the past 6 months according to American Diabetes Association criteria
- Positive for one or more antibodies against GAD65, IAA, IA-2, ICA, or ZNT8
- Daily insulin dose less than 0.5 IU/kg/day for three days before screening
- Fasting C-peptide level greater than 0.1 nmol/L (0.3 ng/mL)
- Age between 6 and 12 years old
- Not currently participating in any other research studies
- Guardian has signed informed consent, child agrees to participate, and children over 8 years old have signed informed consent themselves
You will not qualify if you...
- Having serious chronic or systemic diseases such as tumors, immunodeficiency, heart failure, Cushing's syndrome, kidney diseases, liver diseases, or gallbladder diseases
- Having acute or chronic gastrointestinal diseases like Crohn's disease, ulcerative colitis, GERD, ulcers, celiac disease, or frequent watery stools
- Blood pressure at or above the 95th percentile for gender, age, and height
- Elevated plasma triglycerides above 1.12 mmol/L for children 9 years and under, or above 1.46 mmol/L for children 10 years and older
- Use of antibiotics for 3 or more days within the last month
- Current infectious diseases
- History of gastrointestinal surgery, appendectomy, or hernia surgery
- Evidence of pituitary dysfunction
- Use of drugs other than insulin that affect blood sugar
- Chromosomal abnormalities such as trisomy 21 or Turner syndrome
- Continuous use of probiotics for more than 3 days within the month before enrollment
- Unable to commit sufficient time to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
F
Feihong Luo, Dr
CONTACT
Z
Zhenran Xu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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