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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01900119
First received: July 11, 2013
Last updated: April 9, 2014
Last verified: March 2014
  Purpose

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.

Condition
Severe Aplastic Anemia (SAA)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Compare the oral microbiome of SAA patients prior to treatment and after treatment. [ Time Frame: one year following enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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. Identification of potential pathogens in the oral cavity of patients with severe aplastic anemia could indicate a similar association between oral pathogens and infection in patient who develop respiratory infections that are severe enough to require intubation. This descriptive case-control 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 (cases). The cases will be compared to two groups of controls, namely those SAA patients who did not require intubation that received treatment for SAA and normal healthy volunteers who are age and gender matched. A difference in the oral microbiome will be identified in specimens collected before and after treatment and in those patients who require intubation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. The healthy controls will be recruited from volunteers who present to the Clinical Center and are on the approved healthy volunteer list.

INCLUSION CRITERIA

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

EXCLUSION CRITERIA

Any SAA patient or matched healthy volunteer 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.

Additional exclusion criteria for matched healthy volunteers are:

  • Periodontal disease as defined by the Periodontal Screening and Recording (a score of greater than Code 4 in one sextant)
  • Use of antibiotics or steroids within the last 6 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900119

Contacts
Contact: Nancy Ames, R.N. (301) 451-0565 names@mail.cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Nancy Ames, R.N. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01900119     History of Changes
Other Study ID Numbers: 130161, 13-CC-0161
Study First Received: July 11, 2013
Last Updated: April 9, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Oral Microbiome
Next Generation Sequencing

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014