Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Dietary Supplement: probiotics
- Registration Number
- NCT04579341
- Lead Sponsor
- Ain Shams University
- Brief Summary
Background: Probiotics influence immune homeostasis, through altering gut microbiota. The efficacy of probiotics in diabetes has been shown in preclinical settings as well as in human trials. Interleukin (IL)-21 and IL22 have been implicated in the pathogenesis of T1D. Objectives: to assess the effect of oral supplementation with probiotics on glycemic control as well as IL-21 and IL-22 levels in children with T1D. Methods: This randomized-controlled trial study included 70 children with T1D. Enrolled children aged 5-18 years with disease duration \> 1 year. They were randomly assigned into two groups; intervention group (group A) who received oral probiotics containing Lactobacillus acidophilus La-14 (108 CFU) 0.5 mg once daily. The other group (group B) did not receive any supplementation and served as a control group. Both groups were followed-up for 6 months with assessment of fasting blood glucose (FBG), HbA1c, IL-21 and IL-22 levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- T1D
- other types of DM
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description probiotics arm probiotics probiotics administered in addition to insulin regimen
- Primary Outcome Measures
Name Time Method glycemic control 6 months HbA1C
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ain Shams University
🇪🇬Cairo, Egypt