Back to resultsProbiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- T1D
Exclusion Criteria:
- other types of DM
Sites / Locations
- Ain Shams UniversityRecruiting
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
probiotics arm
control
Arm Description
probiotics administered in addition to insulin regimen
regular insulin regimen
Outcomes
Primary Outcome Measures
glycemic control
HbA1C
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04579341
Brief Title
Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2018 (Actual)
Primary Completion Date
October 28, 2020 (Anticipated)
Study Completion Date
November 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
probiotics arm
Arm Type
Active Comparator
Arm Description
probiotics administered in addition to insulin regimen
Arm Title
control
Arm Type
No Intervention
Arm Description
regular insulin regimen
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
probiotics administration
Primary Outcome Measure Information:
Title
glycemic control
Description
HbA1C
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
T1D
Exclusion Criteria:
other types of DM
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouran Salah, MD
Phone
01116603336
Email
niron85@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Adly, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Ramses
ZIP/Postal Code
11375
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
amira adly, MD
Facility Name
Ain Shams University
City
Cairo
ZIP/Postal Code
11375
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amira Adly, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
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