Trials / Recruiting
RecruitingNCT06198725
Intervention for Children With Type 1 Diabetes Targeting Gut Microbes
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- Children's Hospital of Fudan University · Academic / Other
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The purpose of this project is to establish an early adjuvant treatment program for children with type 1 diabetes targeting gut microbiome, and to evaluate the clinical effect and safety of a dietary product to protect the beta-cell function of newly diagnosed type 1 diabetes children and improve blood sugar control. Plan to adopt the parallel randomized controlled clinical trial method to select newly-diagnosed type 1 diabetes children, and randomly divide them into Usual care group and High fiber diet group at a ratio of 1:1. To comprehensively evaluate the clinical effect and long-term effect of a high fiber dietary intervention product, the changes of beta-cell function, glucose metabolism, and the structure and function of gut microbiota will be compared before and after treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Trimtab | High fiber group will take Trimtab (a kind of multi bran and high fiber grain compound powder) 60g per day to intake 28g dietary fiber for 12 weeks. |
Timeline
- Start date
- 2024-01-08
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2024-01-10
- Last updated
- 2026-03-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06198725. Inclusion in this directory is not an endorsement.