Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
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
1 other identifier
interventional
70
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2018
CompletedFirst Submitted
Initial submission to the registry
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2020
CompletedOctober 8, 2020
October 1, 2020
2.8 years
October 2, 2020
October 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
glycemic control
HbA1C
6 months
Study Arms (2)
probiotics arm
ACTIVE COMPARATORprobiotics administered in addition to insulin regimen
control
NO INTERVENTIONregular insulin regimen
Interventions
Eligibility Criteria
You may qualify if:
- T1D
You may not qualify if:
- other types of DM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ain Shams University
Cairo, Ramses, 11375, Egypt
Ain Shams University
Cairo, 11375, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amira Adly, MD
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 2, 2020
First Posted
October 8, 2020
Study Start
January 21, 2018
Primary Completion
October 28, 2020
Study Completion
November 10, 2020
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share