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Scientists dive deep into immune mysteries of gut diseases to personalize care

NCT ID NCT03369353

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2017

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.