The Effect of Human Milk Oligosaccharides in Children With Type 1 Diabetes Mellitus

Launched by EGE UNIVERSITY · Aug 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of human milk oligosaccharides, a type of carbohydrate found in breast milk, on children with Type 1 diabetes. Researchers aim to see if these oligosaccharides can help improve blood sugar control, preserve insulin-producing cells in the pancreas, and promote healthier gut bacteria. The study will involve 111 children aged 4 to 16 who have been diagnosed with Type 1 diabetes and will last for 36 months. Participants will be divided into three groups: two groups will receive different amounts of human milk oligosaccharides daily, while the third group will receive a placebo that has no active effect.

To be eligible for the study, children must be at least 4 years old, have been diagnosed with Type 1 diabetes within the last 100 days, and show certain autoantibodies that indicate the disease. They also need to have specific blood sugar levels. Participants will receive the oligosaccharides for three months and will be monitored for a year to see how their health changes. This research hopes to provide new insights into managing Type 1 diabetes and improve the overall well-being of children living with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Being at least 48 months of age
• • Diagnosis period \<100 days, in the early stage
• • Exogenous insulin requirement \> 0.5 U/kg/day in the late-stage
• • Positive at least one autoantibody associated with type 1 DM (ICA, IAA, GADA)
• • C-peptide level \<0.2 nmol/L during MMTT
• • Between the 3rd percentile and the 97th percentile weight for age (between -2SD and +2SD)
• Exclusion Criteria:
• • Being breastfed despite the age of 48 months
• • Failure to meet the diagnostic criteria for autoimmune type 1 DM (autoantibody negative)
• • Co-morbidity illness
• • To have taken antibiotics, probiotics, prebiotics and inflammatory drugs in the last one month before participating in the study or during the study