A Description of Bacteria in the Mouths of Patients With Severe Aplastic Anemia

Completed

Conditions studied: Severe Aplastic Anemia (SAA)

In brief

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.

Key facts

Study ID

NCT01900119

Run by

National Institutes of Health Clinical Center (CC)

People needed

24

Starts

2013-12-12

Expected to finish

2019-09-23

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any adult patient (greater than or equal to18 years of age), diagnosed with SAA.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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