- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04579341
Probiotics Supplementation Effect on Glucose Homeostasis in Children With Type 1 Diabetes
October 2, 2020 updated by: Nouran yousef, Ain Shams University
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nouran Salah, MD
- Phone Number: 01116603336
- Email: niron85@hotmail.com
Study Locations
-
-
-
Cairo, Egypt, 11375
- Recruiting
- ain shams University
-
Contact:
- Amira Adly, MD
-
-
Ramses
-
Cairo, Ramses, Egypt, 11375
- Recruiting
- ain shams University
-
Contact:
- Amira Adly, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- T1D
Exclusion Criteria:
- other types of DM
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: probiotics arm
probiotics administered in addition to insulin regimen
|
probiotics administration
|
NO_INTERVENTION: control
regular insulin regimen
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycemic control
Time Frame: 6 months
|
HbA1C
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amira Adly, MD, ain shams University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 21, 2018
Primary Completion (ANTICIPATED)
October 28, 2020
Study Completion (ANTICIPATED)
November 10, 2020
Study Registration Dates
First Submitted
October 2, 2020
First Submitted That Met QC Criteria
October 2, 2020
First Posted (ACTUAL)
October 8, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 2, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Probiotics
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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