Type1 Diabetes MellitusNCT03908021
The Salivary Microbiome in Children With Type 1 Diabetes Mellitus
An observational study of Type1 Diabetes Mellitus, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Microbiome analysis and 16S rRNA gene-based analysis
- How many people
- 66 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2019to 30 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Child
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.
Who may be able to join
- Children with type 1 diabetes mellitus
Who cannot join
- Children Unable to give saliva sample
- Children On antibacterial medicaments
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Microbiome analysis and 16S rRNA gene-based analysis
- Keywords
- diabetes mellitus, children, microbiome
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiome analysis and 16S rRNA gene-based analysisDiagnostic test
microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis | |
| Control | 50 healthy children, preferably their siblings, matched in age and gender. Receives: Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Aug 2019
- Primary completion30 Aug 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908021
- Sponsor's protocol ID
- 0714-18-HMO
- Status last verified
- Jan 2021
- First submitted
- 1 Apr 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Salivary Microbiome in Children With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03908021
- Acronym / sponsor ID
- 0714-18-HMO
- Conditions
- Type1 Diabetes Mellitus
- Keywords
- diabetes mellitus, children, microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children with type 1 diabetes mellitus | – | Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysisSaliva 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, |
| Control | – | Diagnostic Test: Microbiome analysis and 16S rRNA gene-based analysis50 healthy children, preferably their siblings, matched in age and gender. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children with type 1 diabetes mellitus
Key exclusion criteria (2 listed)
- Children Unable to give saliva sample
- Children On antibacterial medicaments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiome analysis and 16S rRNA gene-based analysismicrobial DNA is extracted from the saliva and 16s library is prepared for sequencing. | Diagnostic test | Control, children with type 1 diabetes mellitus |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1 Diabetes Mellitus, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.