Scientists dive deep into immune mysteries of gut diseases to personalize care
NCT ID NCT03369353
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to better understand what causes inflammatory bowel disease (IBD), graft-versus-host disease (GVHD), and other gut problems by analyzing blood and tissue samples from 1,000 patients. Researchers will use advanced lab techniques to track immune system changes over time. The goal is to find specific disease pathways that can lead to more personalized diagnosis and treatment. This is an observational study, not a treatment trial.
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
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2017
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
HCT, Cellular Therapy and Non-HCT patients undergoing endoscopy (patients with IBD and FGID) will be recruited from participating centers. This prospective banking study will continue to enroll patients undergoing HCT, endoscopy for IBD or FGID, and cellular therapy on an ongoing, long-term basis. Additional enrollment will come from patients receiving SARS-CoV-2 vaccination after HCT, solid organ transplant, active or recent malignancy or autoimmune or rheumatologic diagnoses, including patients who did not meet eligibility criteria for other cohorts. Additional patients who are healthy blood or bone marrow donors and may or may not be related to the patients with immune dysfunction or receiving HCT will also be enrolled in the study to serve as healthy controls.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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.
A. Inclusion criteria for HCT patients: 1. Patients must be at least 1 month old and weigh \>/= 3 kg. 2. Patients receiving any allogeneic or autologous hematopoietic stem cell transplantation (bone marrow, peripheral blood, or cord blood transplant). 3. Patients and/or parents or legal guardians must sign a written informed consent. B. Inclusion Criteria for Adoptive Cellular Therapy (CT) patients: 1. Weight ≥3 kg 2. Patients receiving adoptive cellular therapy 3. Patient and/or legal guardian must sign written informed consent C. Inclusion criteria for Healthy Donor Blood volunteers: 1. Age 18+ 2. Participant does not have signs/symptoms of present illness 3. Participant does not have a known disease affecting the immune system 4. Participant is not on any medication/s that suppress immune system 5. Obtain informed consent D. Inclusion criteria for HCT Related and Unrelated Donors: 1. Age \>1 years of age 2. Weight \>3 kg 3. Obtain informed consent E. Inclusion criteria for IBD \& FGID patients: 1. Patients must be at least 6 years old and weigh \>/= 10 kg. 2. Patients being evaluated for IBD (new diagnosis or follow up of established disease), OR 3. Patients being evaluated for FGID (new diagnosis or follow up of established disease). 4. Obtain informed consent F. Inclusion criteria for HCT \& Cell Therapy Household Members: 1. Household member of a patient who is receiving HCT or Cell Therapy and who is participating in the PREDICT study 2. Age \>1 years of age 3. Weight \>3 kg 4. Obtain informed consent
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Stem cell infusions put to the test against a tough transplant complication
- Can early symptom relief predict who stays on IBD biologic?
- Can a liquid diet calm Crohn's in kids?
- Which IBD therapy works best for kids? researchers compare two approaches
- Massive Real-World database aims to map how chronic diseases interact