Effect of human milk oligosaccharides on children with type 1 diabetes
The Effects of Synthetic Human Milk Oligosaccharides on Gut Microbiota, Pancreas Beta Cell Preservation and Metabolic Control in Children With Type 1 Diabetes Mellitus
This study is testing whether a special sugar found in human milk can help young children with type 1 diabetes by possibly improving their health and managing their condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 111 (estimated) |
| Ages | 4 Years to 16 Years |
| Sex | All |
| Sponsor | Ege University Academic / other |
| Locations | 1 site (İzmir, Bornova) |
| Trial ID | NCT05521061 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of 2-fucosyllactose, a human milk oligosaccharide, on children diagnosed with type 1 diabetes mellitus. The focus is on understanding how this intervention may influence the autoimmune processes associated with the disease, particularly in the early stages of diagnosis. Participants must be between 48 months and 100 days post-diagnosis and show specific autoantibody markers. The study aims to explore potential metabolic improvements through dietary intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 48 months to 100 days post-diagnosis of type 1 diabetes who meet specific autoantibody and metabolic criteria.
Not a fit: Patients who are breastfed beyond 48 months or do not meet the diagnostic criteria for autoimmune type 1 diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve metabolic control and overall health outcomes for children with type 1 diabetes.
How similar studies have performed: While there have been studies exploring dietary interventions in diabetes, the specific use of human milk oligosaccharides in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
İzmir, Bornova
- Ege University — İzmir, Bornova, Turkey (Recruiting)
Study contacts
- Study coordinator: Raika Durusoy
- Email: raika.durusoy@ege.edu.tr
- Phone: +905358603104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.