NCT03908021

The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 66 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: —

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.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Microbiome analysis and 16S rRNA gene-based analysis	microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-30
• Completion: 2021-12-30
• First posted: 2019-04-09
• Last updated: 2022-03-29

Locations

1 site across 1 country: Israel