Allogeneic Peripheral Blood Stem Cell TransplantNCT00476450
Effects of Stem Cell Transplantation on Bacteria in the Mouth
An observational study of Allogeneic Peripheral Blood Stem Cell Transplant, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Peripheral Blood Stem Cell Transplant
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2007to 7 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Effects of Peripheral Blood Stem Cell Transplantation on the Microbial Flora of the Oral Cavity
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.
Read more
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:
- <TAB>-About one-fourth teaspoon of saliva is collected with a suction device similar to that used in a dental office.
- <TAB>-Plaque from the surface of a tooth is collected with a plastic toothpick.
- <TAB>-Skin cells from the inside of the cheek and the surface of the tongue are collected with a small soft brush.
- <TAB>-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.
Read the detailed description
The mouth is a complex biological ecosystem normally containing over 700 different species of bacteria. These bacteria live in an exopolysacchride matrix biofilm. Usually, bacteria colonize the oral cavity benignly. However, there are several studies in critically ill patients demonstrating changes in oral flora with 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. A common complication of allogeneic peripheral blood stem cell transplant (PBSCT) is infection and pneumonia. Identification of potential pathogens in the oral cavity of allogeneic stem cell patients could indicate a similar association between oral pathogens and infection. A few studies describe the oral microbial community in these patients and the possibility that these organisms are a source of infection.
The primary objective of this study is to describe the changes in oral microbial flora of allogeneic SCT patients at three time points during their treatment and recovery. Observed differences in microbial organisms from baseline (prior to transplantation), through neutropenia (within 48 hours of nadir post-transplantation) and myeloid engraftment (14-21 days post transplantation) will be described.
In the course of their treatment, if patients develop respiratory signs and symptoms that require either a re-admission to an inpatient unit or intensive care unit admission, then additional oral specimens will be collected.
The secondary objective is to assess the oral microbial flora found after development of respiratory signs and symptoms in allogeneic PBSCT patients in the first 100 days post-transplant. In addition, if the patient requires intubation, tracheal aspirates and oral specimens will be collected.
The population is composed of adult patients who are planning to undergo an allogeneic PBSCT and can provide informed consent. The design is a prospective, descriptive study of the microbial flora of the oral cavity of adult allogeneic stem cell transplant patients. Saliva specimens, dental plaque and mucosal brushings will be collected at the three different times. Oral specimens will be obtained from patients who develop respiratory signs or symptoms that require an additional inpatient or intensive care unit admission. Patients will be followed and assessed for respiratory signs, symptoms, inpatient or ICU admission until day 100 post-transplant. The presence of bacteria (type and species) will be determined by molecular genetics. The identification of bacteria will be studied using various comparative molecular techniques, including DNA arrays and Real-Time Polymerase Chain Reaction (RT-PCR).
- Keywords
- Oral Microbial Flora, Hematopoietic Stem Cell Transplant, Allogeneic Stem Cell Transplant
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the oral microbiome
Measured: Baseline, nadir of ANC and engraftment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study start16 May 2007
- Study completion7 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Peripheral Blood Stem Cell TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy Ames, R.N., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476450
- Sponsor's protocol ID
- 070153
- Other IDs
- 07-CC-0153
- Status last verified
- 7 Mar 2016
- First submitted
- 19 May 2007
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
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.
PubMed 15853940Mager 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.
PubMed 12834503Kolenbrander 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.
PubMed 12209001
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peripheral Blood Stem Cell Transplantation on the Microbial Flora of the Oral Cavity
- ClinicalTrials.gov ID
- NCT00476450
- Acronym / sponsor ID
- 070153
- Keywords
- Oral Microbial Flora, Hematopoietic Stem Cell Transplant, Allogeneic Stem Cell Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 16 May 2007
- Study completion
- 7 Mar 2016
- First posted
- 22 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- <TAB>-About one-fourth teaspoon of saliva is collected with a suction device similar to that used in a dental office.
- <TAB>-Plaque from the surface of a tooth is collected with a plastic toothpick.
- <TAB>-Skin cells from the inside of the cheek and the surface of the tongue are collected with a small soft brush.
- <TAB>-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.
Detailed description
The mouth is a complex biological ecosystem normally containing over 700 different species of bacteria. These bacteria live in an exopolysacchride matrix biofilm. Usually, bacteria colonize the oral cavity benignly. However, there are several studies in critically ill patients demonstrating changes in oral flora with 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. A common complication of allogeneic peripheral blood stem cell transplant (PBSCT) is infection and pneumonia. Identification of potential pathogens in the oral cavity of allogeneic stem cell patients could indicate a similar association between oral pathogens and infection. A few studies describe the oral microbial community in these patients and the possibility that these organisms are a source of infection.
The primary objective of this study is to describe the changes in oral microbial flora of allogeneic SCT patients at three time points during their treatment and recovery. Observed differences in microbial organisms from baseline (prior to transplantation), through neutropenia (within 48 hours of nadir post-transplantation) and myeloid engraftment (14-21 days post transplantation) will be described.
In the course of their treatment, if patients develop respiratory signs and symptoms that require either a re-admission to an inpatient unit or intensive care unit admission, then additional oral specimens will be collected.
The secondary objective is to assess the oral microbial flora found after development of respiratory signs and symptoms in allogeneic PBSCT patients in the first 100 days post-transplant. In addition, if the patient requires intubation, tracheal aspirates and oral specimens will be collected.
The population is composed of adult patients who are planning to undergo an allogeneic PBSCT and can provide informed consent. The design is a prospective, descriptive study of the microbial flora of the oral cavity of adult allogeneic stem cell transplant patients. Saliva specimens, dental plaque and mucosal brushings will be collected at the three different times. Oral specimens will be obtained from patients who develop respiratory signs or symptoms that require an additional inpatient or intensive care unit admission. Patients will be followed and assessed for respiratory signs, symptoms, inpatient or ICU admission until day 100 post-transplant. The presence of bacteria (type and species) will be determined by molecular genetics. The identification of bacteria will be studied using various comparative molecular techniques, including DNA arrays and Real-Time Polymerase Chain Reaction (RT-PCR).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the oral microbiome
Time frame: Baseline, nadir of ANC and engraftment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 15853940Socransky SS, Haffajee AD. Periodontal microbial ecology. Periodontol 2000. 2005;38:135-87. doi: 10.1111/j.1600-0757.2005.00107.x. No abstract available.
- Background: PubMed 12834503Mager 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.
- Background: PubMed 12209001Kolenbrander 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Ames, R.N. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Peripheral Blood Stem Cell Transplant, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the oral microbiome (time frame: Baseline, nadir of ANC and engraftment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00476450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.