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NCT03908021 Clinical Trial

The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

Type1 Diabetes Mellitus Clinical Trial

Official title:
The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03908021
Other study ID # 0714-18-HMO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date December 30, 2021

Study information
Verified date January 2021
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date December 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers
Gender All
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria: • Children with type 1 diabetes mellitus Exclusion Criteria: - Children Unable to give saliva sample - Children On antibacterial medicaments

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Microbiome analysis and 16S rRNA gene-based analysis
microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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