The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

Completed

• Conditions: Type1 Diabetes Mellitus
• Interventions: Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis

• Registration Number: NCT03908021
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-07
• Study First Posted: 2019-04-09
• Study Start: 2019-08-01
• Status Verified: 2021-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-12-30
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Children with type 1 diabetes mellitus

Exclusion Criteria

• Children Unable to give saliva sample
• Children On antibacterial medicaments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children with type 1 diabetes mellitus	Microbiome analysis and 16S rRNA gene-based analysis	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,
Control	Microbiome analysis and 16S rRNA gene-based analysis	50 healthy children, preferably their siblings, matched in age and gender.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel