The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

Study Overview
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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.

Official Title
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The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

Conditions
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Type1 Diabetes Mellitus

Intervention / Treatment
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* Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with type 1 diabetes mellitus<br>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, | Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis<br>* microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.<br>|
| Control<br>50 healthy children, preferably their siblings, matched in age and gender. | Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis<br>* microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus | Profile salivary microbiota in diabetic children followed by bioinformatics analyses and combining the data with the alteration in caries index, medications, state of the disease and salivary components to give a list of specific bacteria that are different in the diabetic child from healthy population. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, children, microbiome