The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

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.

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Key information

Conditions

Type1 Diabetes Mellitus Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children with type 1 diabetes mellitus

Exclusion criteria

Children Unable to give saliva sample
Children On antibacterial medicaments

Treatment and study plan

Microbiome analysis and 16S rRNA gene-based analysis

Diagnostic Test

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

Primary outcomes

profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Apr 9, 2019
Registry last updated: Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed