The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

NCT03908021 | Completed

• 1 other identifier: 0714-18-HMO
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Keywords

diabetes mellitus; children; microbiome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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,

Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis

Control

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

Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis

Interventions

Microbiome analysis and 16S rRNA gene-based analysis DIAGNOSTIC_TEST

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

Control; children with type 1 diabetes mellitus

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Children with type 1 diabetes mellitus

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 9, 2019
• Study Start: August 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 29, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)