The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

NCT ID: NCT03908021

Last Updated: 2022-03-29

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

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-30

Brief Summary

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Aims: To profile the oral microbiome of children with type 1 diabetes mellitus, and to compare it to healthy children while taking into account other aspects of the oral environment.

Research: exploring the differences between oral microflora of children with type 1 diabetes mellitus and control healthy children using salivary microbiome. The investigators will furthermore intend to analyze the differences of salivary flow rate, pH, glucose, calcium, inorganic phosphate and urea between the two groups.

Detailed Description

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Saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the Pediatric Endocrinology Clinic, Hadassah University Hospital Mt. Scopus and Ein Kerem, Jerusalem, Isreal, will be compared to 50 healthy children, preferably their siblings, matched in age and gender. Each patient or their legal guardian will sign an informed consent to participate in the study. The investigators will request a permission to access the medical records of the patients. Data will be collected from patient medical history. The investigators will measure salivary flow rate, pH and glucose, salivary Calcium, inorganic phosphate and urea and perform microbiome analysis and 16S rRNA gene-based analysis comparing children with diabetes to healthy children.

Conditions

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Type1 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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children with type 1 diabetes mellitus

Saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the Pediatric Endocrinology Clinic, Hadassah University Hospital Mt. Scopus and Ein Kerem, Jerusalem, Isreal,

Microbiome analysis and 16S rRNA gene-based analysis

Intervention Type DIAGNOSTIC_TEST

microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.

Control

50 healthy children, preferably their siblings, matched in age and gender.

Microbiome analysis and 16S rRNA gene-based analysis

Intervention Type DIAGNOSTIC_TEST

microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.

Interventions

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Microbiome analysis and 16S rRNA gene-based analysis

microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

• Children with type 1 diabetes mellitus

Exclusion Criteria

* Children Unable to give saliva sample
* Children On antibacterial medicaments
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0714-18-HMO

Identifier Type: -

Identifier Source: org_study_id

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