- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01900119
A Description of Bacteria in the Mouths of Patients With Severe Aplastic Anemia
A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia
Background:
- This research is being done to describe the types of bacteria found in the mouths of patients who have severe aplastic anemia (SAA) and are treated with drugs that suppress the immune system or with stem cell transplant. People with SAA who receive these treatments are more likely to get infections. Studies show that there might be a link between the bacteria in your mouth and those bacteria that can cause infections. The bacteria found in the mouths of patients with SAA will be described.
Objectives:
- To understand the changes in mouth bacteria that are related to treatment and to describe the oral bacterial environment.
Eligibility:
- Adults at least 18 years of age who are going to be treated for SAA.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will answer questions about their medical history and dental care. Their mouths will be examined.
- Participants with SAA will be tested during treatment for their disease, over the course of 1 year. All participants with SAA will be tested at 3 scheduled appointments. Any participants who require a breathing tube will receive additional tests.
- Healthy volunteers will be tested during 1 visit.
- Participants will give two samples each time. A saliva sample will be taken with a disposable padded tool. Skin cells will be collected from the tongue with a small plastic brush.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- All adult patients who are scheduled to receive treatment for SAA will be screened for this protocol. These patients will be recruited from the numerous protocols that are actively accepting new research participants at the Clinical Center, NIH.
INCLUSION CRITERIA
Any adult patient (greater than or equal to18 years of age), diagnosed with SAA.
EXCLUSION CRITERIA
Any SAA patient found to have significant tooth loss from decay or is edentulous are excluded. This exclusion criteria will be assessed by the PI or her representative prior to signing the informed consent.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the oral microbiome of SAA patients prior to treatment and after treatment.
Time Frame: one year following enrollment
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Change in the oral microbiome of patients with SAA.
Bacterial data obtained from sequencing
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one year following enrollment
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Collaborators and Investigators
Publications and helpful links
General Publications
- Socransky SS, Haffajee AD. Periodontal microbial ecology. Periodontol 2000. 2005;38:135-87. doi: 10.1111/j.1600-0757.2005.00107.x. No abstract available.
- Mager DL, Ximenez-Fyvie LA, Haffajee AD, Socransky SS. Distribution of selected bacterial species on intraoral surfaces. J Clin Periodontol. 2003 Jul;30(7):644-54. doi: 10.1034/j.1600-051x.2003.00376.x.
- Kolenbrander PE, Andersen RN, Blehert DS, Egland PG, Foster JS, Palmer RJ Jr. Communication among oral bacteria. Microbiol Mol Biol Rev. 2002 Sep;66(3):486-505, table of contents. doi: 10.1128/MMBR.66.3.486-505.2002.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130161
- 13-CC-0161
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe Aplastic Anemia (SAA)
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National Heart, Lung, and Blood Institute (NHLBI)CompletedSevere Aplastic Anemia (SAA)United States
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AmgenWithdrawn
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Novartis PharmaceuticalsActive, not recruitingSevere Aplastic Anemia (SAA)Japan, Korea, Republic of, China, Taiwan
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Regeneron PharmaceuticalsRecruitingSevere Aplastic Anemia (SAA)United States, France, Korea, Republic of, United Kingdom
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National Heart, Lung, and Blood Institute (NHLBI)CompletedSevere Aplastic Anemia (SAA) | Myelodysplastic Syndrome (MDS) With Refractory Anemia (RA)United States
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University of UtahNovartisCompletedSevere Aplastic Anemia | Moderate Aplastic Anemia | Very Severe Aplastic AnemiaUnited States
-
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-
National Heart, Lung, and Blood Institute (NHLBI)CompletedSevere Aplastic Anemia, Refractory | Severe Aplastic Anemia, RelapseUnited States
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions