Clinical trial NCT01900119: A Description of Bacteria in the Mouths of Patients With Severe Aplastic Anemia
Official title: A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Aplastic Anemia (SAA)
Keywords: Oral Microbiome
Next Generation Sequencing
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: 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.

Detailed description: The mouth is a complex biological ecosystem normally containing over 700 different species of bacteria. Some of these bacteria live in an exopolysacchride matrix biofilm and occupy specific niches in this complex oral environment. Understanding the oral environment and the microbiota that inhabit it will assist in determining their impact on health and disease. There are several studies in critically ill patients demonstrating changes in oral bacteria related to acute illness. Identification of respiratory pathogens in the mouth has led researchers to hypothesize that a relationship exists between the oral cavity and pulmonary infections. This descriptive study will characterize the oral microbiota of patients who have severe aplastic anemia (SAA). Patients will be followed for 1 year after treatment for development of respiratory symptoms that require intubation. A difference in the oral microbiome will be identified in specimens collected before and after treatment.

Eligibility criteria: * 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.

Primary outcomes:
measure: Compare the oral microbiome of SAA patients prior to treatment and after treatment.
timeFrame: one year following enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institutes of Health Clinical Center (CC)
name: Nancy Ames, R.N.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.