NIH Clinical Research Studies

Protocol Number: 07-CC-0153

Active Accrual, Protocols Recruiting New Patients

Title:
Effects of Peripheral Blood Stem Cell Transplantation on the Microbial Flora of the Oral Cavity
Number:
07-CC-0153
Summary:
This study will examine bacteria in patients' mouths at different times during stem cell transplantation and recovery. Drugs patients receive as part of the conditioning process for a stem cell transplant increase their risk of infection. There might be a link between the bacteria in the mouth and the bacteria that can cause infections. Knowing the changes in bacteria might help researchers determine the best method to prevent infections.

Patients 18 years of age and older who are scheduled to receive a stem cell transplant may be eligible for this study.

Participants undergo the following procedures:

Review of medical records

Interview about their oral care

Oral examination

Collection of oral specimens just before the stem cell transplant, immediately after the transplant, and 3 weeks after the transplant. The specimens are obtained as follows:

? -About one-fourth teaspoon of saliva is collected with a suction device similar to that used in a dental office.

? -Plaque from the surface of a tooth is collected with a plastic toothpick.

? -Skin cells from the inside of the cheek and the surface of the tongue are collected with a small soft brush.

? -If a tube is inserted into the patient's lungs to assist breathing and the patient is admitted to the intensive care unit, a specimen from the lungs is collected.

Patients are followed for 100 days after their transplant. Additional oral specimens are obtained from those who develop signs and symptoms of respiratory infection.

Sponsoring Institute:
National Institutes of Health Clinical Center (CC)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

All adult patients admitted to the Clinical Research Center of the NIH who are 18 years of age or older who are scheduled to undergo an allogeneic PBSCT are eligible for enrollment. Collection of oral specimens in children who are allogeneic transplant recipients would increase the anxiety in these participants and may require sedation. For this reason children will be excluded from this protocol.

All adult patients who provide informed consent and who are scheduled to receive an allogeneic bone marrow transplant are eligible for enrollment.

EXCLUSION CRITERIA:

Patients who have had recent oral surgery or oral trauma will be excluded.

Patients with tracheostomies will also be excluded.

Patients with sickle cell disease or chronic granulomatous disease who are being transplanted will be excluded from the protocol.

Patients who are less than 18 years of age will be excluded.

Special Instructions:
Currently Not Provided
Keywords:
Oral Microbial Flora
Allogeneic PBSCT
Recruitment Keyword(s):
Oral Microbial Flora
Allogeneic Stem Cell Transplant
Condition(s):
Allogeneic Peripheral Blood Stem Cell Transplant
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
Warren G. Magnuson Clinical Center

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Socransky SS, Haffajee AD. Periodontal microbial ecology. Periodontol 2000. 2005;38:135-87. Review. No abstract available.

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.

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. Review.

Active Accrual, Protocols Recruiting New Patients

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