A Description of Bacteria in the Mouths of Patients With Severe Aplastic Anemia
|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.|
|ClinicalTrials.gov Identifier: NCT01900119|
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : December 13, 2018
- 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.
- To understand the changes in mouth bacteria that are related to treatment and to describe the oral bacterial environment.
- Adults at least 18 years of age who are going to be treated for SAA.
- Healthy volunteers at least 18 years of age.
- 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.
|Condition or disease|
|Severe Aplastic Anemia (SAA)|
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia|
|Study Start Date :||July 11, 2013|
|Actual Primary Completion Date :||July 5, 2016|
|Actual Study Completion Date :||July 5, 2016|
- Compare the oral microbiome of SAA patients prior to treatment and after treatment. [ Time Frame: one year following enrollment ]Change in the oral microbiome of patients with SAA. Bacterial data obtained from sequencing
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): NCT01900119
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Nancy Ames, R.N.||National Institutes of Health Clinical Center (CC)|