Scientists track mouth health to unlock secrets of transplant complication
NCT ID NCT03602599
First seen Jun 24, 2026 · Last updated Jul 29, 2026 · Updated 9 times
Summary
This study followed 190 adults who had or were about to have a stem cell transplant from a donor. Researchers tracked changes in the mouth, like dryness or sores, to learn more about chronic graft-versus-host disease (cGVHD). Participants provided saliva, mouth swabs, and had dental exams over three years. The goal was to better understand how cGVHD develops in the mouth, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could improve how doctors detect and manage oral complications from chronic graft-versus-host disease.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly benefit participants and may not lead to new therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
190 people
The number who actually took part.
- Started
-
Nov 2018
- Finished
-
May 2026
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Subjects in Cohort NT and Cohort PT will be scheduled to undergo allogeneic hematopoietic stem cell transplant at the NIH (Cohort NT) or have already undergone allogeneic HSCT at the NIH or another institution (Cohort PT) and are within 3 years of most recent bone marrow transplant. Subjects in Cohort HL and Cohort HS will be healthy volunteers and may potentially be age- and/or sex-matched with a transplant patient participant. All subjects will be at least 18 years of age.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Subjects in Cohort NT and Cohort PT must satisfy all of the following criteria in order to participate in the study: * Scheduled to undergo allogeneic HSCT at the NIH (Cohort NT) or have already undergone allogeneic HSCT at the NIH or another institution (Cohort PT) and are within 3 years of most recent bone marrow transplant * Willing to participate in protocol evaluations including saliva collection, oral swab collection, and completion of patient-reported outcome (PRO) forms * Willing to return to the NIH Dental Clinic for scheduled evaluations * Be at least 18 years of age at screening * Be able to understand and provide written informed consent * Subjects in Cohort HL and Cohort HS must satisfy all of the following criteria in order to participate in the study: * Willing to undergo oral exam and participate in Visit 1 protocol evaluations including saliva collection, oral swab collection and oral biopsies. * Be at least 18 years of age at screening * Be able to understand and provide written informed consent * Potentially be age- and/or sex-matched with a transplant patient * Subjects in Cohort HL must additionally be willing and able to return to the NIH Dental Clinic for scheduled visits across 1 year and participate in evaluations including saliva collection, oral swab collection, and completion of PRO forms EXCLUSION CRITERIA: * Subjects in any Cohort will be excluded if they are pregnant, as pregnancy can have a confounding effect on the oral microbiome * Subjects in Cohort NT may not participate in the study if, in the opinion of the NIH transplant team, participation in the protocol would not be safe or in the subject s best interest * Subjects in Cohort PT. There are no additional exclusion criteria for subjects in this cohort. * Subjects in Cohorts HL and Cohort HS may not participate in the study if they meet either of the following criteria: * Have any acute oral mucosal or dental infection requiring multiple dental appointments or specialist referral for treatment; uncontrolled chronic disease; active systemic illness; are currently undergoing orthodontic treatment; history of frequent opportunistic infection; autoimmune disease; immunosuppressive medications; or prior organ, bone marrow, or peripheral blood stem cell transplant * Are taking medications or are on other ongoing therapies that have a known or suspected major impact on the oral microbiome * Subjects in Cohort HL additionally may not participate if they are planning to become pregnant within the next year or refuse to have oral biopsies.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic graft versus host disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can adding rituximab improve remission in chronic GVHD?
- Can a new drug stop the Body's attack after stem cell transplants?
- Can a new pill tame the immune System's attack after stem cell transplants?
- Can a new pill outperform standard care for a tough transplant complication?
- Can meditation tame the Long-Term side effects of a stem cell transplant?