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NCT04579341 Clinical Trial

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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
The Effect of Probiotics Supplementation on Glucose Homeostasis, Lipid Profile and Interleukin (IL)-21 and IL-22 Levels in Children With Type 1 Diabetes: A Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04579341
Other study ID # Probiotics
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 21, 2018
Est. completion date November 10, 2020

Study information
Verified date October 2020
Source Ain Shams University
Contact Nouran Salah, MD
Phone 01116603336
Email niron85@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date November 10, 2020
Est. primary completion date October 28, 2020
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

- T1D

Exclusion Criteria:

- other types of DM

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• probiotics
probiotics administration

Locations
Country Name City State
Egypt Ain Shams University Cairo Ramses
Egypt Ain Shams University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary glycemic control HbA1C 6 months
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