CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01900119
NCT01900119N/ACompleted

A Description of the Oral Microbiome of Patients With Severe Aplastic Anemia

National Institutes of Health Clinical Center (CC)·observational·Posted Jul 16, 2013·Updated Dec 17, 2019

In Brief

An observational study for Severe Aplastic Anemia (SAA). Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 16, 2013
Enrollment StartDec 12, 2013
Primary CompletionJul 5, 2016
Study CompletionSep 23, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.0 years ago