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The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03908021
Enrollment
66
Registered
2019-04-09
Start date
2019-08-01
Completion date
2021-12-30
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1 Diabetes Mellitus

Keywords

diabetes mellitus, children, microbiome

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.

Interventions

DIAGNOSTIC_TESTMicrobiome analysis and 16S rRNA gene-based analysis

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

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years

Inclusion criteria

• Children with type 1 diabetes mellitus

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus1 yearProfile 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026