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Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

NCT06198725 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Adfontes (Shanghai) Bio-technology Co.,Ltd.

    collaborator UNKNOWN

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Feihong Luo, Dr · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06198725 on ClinicalTrials.gov