Severe Aplastic Anemia (SAA)NCT01900119
A Description of Bacteria in the Mouths of Patients With Severe Aplastic Anemia
An observational study of Severe Aplastic Anemia (SAA), run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Severe Aplastic Anemia (SAA)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2013to 23 Sep 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient (greater than or equal to18 years of age), diagnosed with SAA.
Who cannot join
- 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.
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: A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia
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.
Read more
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.
Read the 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.
- Conditions
- Severe Aplastic Anemia (SAA)
- Keywords
- Oral Microbiome, Next Generation Sequencing
- Medical subject headings
- Anemia, Aplastic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study start12 Dec 2013
- Primary completion5 Jul 2016
- Study completion23 Sep 2019
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 Severe Aplastic Anemia (SAA)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nancy Ames, R.N., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900119
- Sponsor's protocol ID
- 130161
- Other IDs
- 13-CC-0161
- Status last verified
- 23 Sep 2019
- First submitted
- 11 Jul 2013
- Last updated
- 17 Dec 2019
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia
- ClinicalTrials.gov ID
- NCT01900119
- Acronym / sponsor ID
- 130161
- Conditions
- Severe Aplastic Anemia (SAA)
- Keywords
- Oral Microbiome, Next Generation Sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Dec 2013
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 16 Jul 2013 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient (greater than or equal to18 years of age), diagnosed with SAA.
Key exclusion criteria (1 listed)
- 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.
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
Compare the oral microbiome of SAA patients prior to treatment and after treatment.
Time frame: one year following enrollment
Change in the oral microbiome of patients with SAA. Bacterial data obtained from sequencing
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 17 Dec 2019.
- 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 Severe Aplastic Anemia (SAA), 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 1 inclusion and 1 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 17 Dec 2019. 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?
Compare the oral microbiome of SAA patients prior to treatment and after treatment. (time frame: one year following enrollment). 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 NCT01900119, 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 17 Dec 2019.