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The Salivary Microbiome in Children With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03908021
Recruitment Status : Enrolling by invitation
First Posted : April 9, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

Aims: To profile the oral microbiome of children with type 1 diabetes mellitus, and to compare it to heathy 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.


Condition or disease Intervention/treatment
Type1 Diabetes Mellitus Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: The Salivary Microbiome in Children With Type 1 Diabetes Mellitus
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
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
microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.

Control
50 healthy children, preferably their siblings, matched in age and gender.
Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis
microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.




Primary Outcome Measures :
  1. profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

• Children with type 1 diabetes mellitus

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908021


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization

Additional Information:

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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03908021     History of Changes
Other Study ID Numbers: 0714-18-HMO
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hadassah Medical Organization:
diabetes mellitus
children
microbiome

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases