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

NCT ID: NCT04579341

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-21

Study Completion Date

2020-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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probiotics arm

probiotics administered in addition to insulin regimen

Group Type ACTIVE_COMPARATOR

probiotics

Intervention Type DIETARY_SUPPLEMENT

probiotics administration

control

regular insulin regimen

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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probiotics

probiotics administration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* T1D

Exclusion Criteria

* other types of DM
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Nouran yousef

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amira Adly, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University

Cairo, Ramses, Egypt

Site Status RECRUITING

Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nouran Salah, MD

Role: CONTACT

01116603336

Facility Contacts

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amira adly, MD

Role: primary

Amira Adly, MD

Role: primary

Other Identifiers

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Probiotics

Identifier Type: -

Identifier Source: org_study_id

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