Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes

Ain Shams University

Status: Unknown

Conditions: Diabetes Mellitus, Type 1

Treatments: Dietary Supplement: probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT04579341

Probiotics

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• T1D

Exclusion criteria

• other types of DM

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

probiotics arm

Active Comparator group

Description:

probiotics administered in addition to insulin regimen

Treatment:

Dietary Supplement: probiotics

control

No Intervention group

Description:

regular insulin regimen