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

NCT01900119 | Completed

• 2 other identifiers: 13016113-CC-0161
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Aplastic Anemia (SAA)

Keywords

Oral Microbiome; Next Generation Sequencing

Outcome Measures

Primary Outcomes (1)

• Compare the oral microbiome of SAA patients prior to treatment and after treatment.

  Change in the oral microbiome of patients with SAA. Bacterial data obtained from sequencing

  one year following enrollment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 15853940 BACKGROUND

• 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.

  PMID: 12834503 BACKGROUND

• 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.

  PMID: 12209001 BACKGROUND

MeSH Terms

Conditions

Anemia, Aplastic

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases

Study Officials

• Nancy Ames, R.N.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 16, 2013
• Study Start: December 12, 2013
• Primary Completion: July 5, 2016
• Study Completion: September 23, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-09-23

Locations

US (1)