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

NARecruitingINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

May 28, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Diabetes MellitusType1diabetes
Interventions
DIETARY_SUPPLEMENT

2-fucosyllactose

Volunteers will be visited to provide the investigational product/placebo to the diets of the patients included in the study for 3 months, and the use of the investigational product/placebo will be monitored. Parents will be trained by their fellows to provide synthetic breast milk oligosaccharides/placebo, the products to be used in the study will be provided by the scholars on a weekly basis, and their daily intake and possible problems will be monitored through weekly interviews. In this study, it is planned to supplement the diet of the placebo group with 1.5 g/day maltodextrins to approximately half of the diet and to supplement the other half with 3 g/day maltodextrins, after the group was randomized within itself. Effects of these doses on metabolic control are not expected. Maltodextrine is in powder form, its dosage of up to 3 g/day has a negligible effect on blood glucose, it has a neutral taste, it is cheap and easy to find, and it is safe and ineffective.

Trial Locations (1)

Unknown

RECRUITING

Ege University, Izmir

All Listed Sponsors
collaborator

Acibadem University

OTHER

collaborator

Eskisehir Osmangazi University

OTHER

lead

Ege University

OTHER