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Sex Differences in Oral Bacteria

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01583803
First Posted: April 24, 2012
Last Update Posted: December 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
King's College London
Information provided by (Responsible Party):
Amrita Ahluwalia, Queen Mary University of London
  Purpose
Females have a lower incidence of hypertensive and cardiovascular disorders that may relate to differences in nitrogen oxides in the blood and saliva. Some nitrogen oxides are recycled with the help of oral bacteria to nitric oxide which is protective against vascular disorders. This study will test the hypothesis that females have different numbers and species of these nitrogen-oxide reducing bacteria.

Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels

Further study details as provided by Amrita Ahluwalia, Queen Mary University of London:

Primary Outcome Measures:
  • Bacterial species identification [ Time Frame: At baseline ]

Secondary Outcome Measures:
  • Bacterial count [ Time Frame: At baseline ]
  • Blood pressure [ Time Frame: At baseline ]
  • Nitrogen oxide levels in biological fluids [ Time Frame: At baseline ]
  • Oral nitrate reduction [ Time Frame: At baseline ]

Biospecimen Retention:   Samples Without DNA
Urine, saliva and plasma

Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Males
Females

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form

Exclusion Criteria:

  1. Healthy subjects unwilling to consent
  2. History of hypertension, diabetes or hypertensive on BP measurement
  3. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
  4. History of any serious illnesses, including recent infections or trauma
  5. Subjects taking systemic medication (other than the oral contraceptive pill)
  6. Subjects with self-reported use of mouthwash or tongue scrapes
  7. Subjects with recent or current antibiotic use (within 3 months)
  8. Subjects with a history, or recent treatment of (within last 3 months) of any oral condition (excluding caries), including gingivitis, periodontitis and halitosis
  Contacts and Locations
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): NCT01583803


Locations
United Kingdom
William Harvey Heart Centre
London, United Kingdom, EC1M 6BQ
Sponsors and Collaborators
Queen Mary University of London
King's College London
Investigators
Principal Investigator: Amrita Ahluwalia, PhD Queen Mary University London
  More Information

Publications:
Responsible Party: Amrita Ahluwalia, Professor of Vascular Pharmacology, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01583803     History of Changes
Other Study ID Numbers: 12/LO/0108
First Submitted: April 20, 2012
First Posted: April 24, 2012
Last Update Posted: December 21, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Cardiovascular Diseases