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Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: Physical exams, Ultrasound, MRI scans, Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Design: Affected participants will have clinic visits every 6 months for 3 years."
  • "Once a year, they will have these procedures: A physical exam with blood and stool samples."
  • "Ultrasound of the abdomen."
  • "Magnetic resonance imaging (MRI) scan."
  • "Questionnaires."
  • "Midyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires Healthy relatives will have 1 blood draw for genetic tests."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people over time to learn more about inflammatory bowel disease (IBD), which causes long-term swelling in the digestive tract. Researchers will study genes, immune cells, and how diet, medicines, and IBD affect these cells. Adults with IBD or certain gene changes linked to IBD, and their healthy close relatives, may join.

Background: Inflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells. Objective: To better understand IBD over time. Eligibility: Adults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed. Design: Affected participants will have clinic visits every 6 months for 3 years. Once a year, they will have these procedures: A physical exam with blood and stool samples. Ultrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines. Magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines. Colonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken. Upper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken. Questionnaires. Participants will answer questions about their disease and their diet. Midyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires Healthy relatives will have 1 blood draw for genetic tests.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For the IBD group: Be 18 to 85 years old.
  • Have a confirmed diagnosis of Crohn’s disease, ulcerative colitis, or IBD linked to another health condition; or have a known genetic condition or gene change linked to IBD risk, with or without symptoms.
  • Have a doctor who refers you and can manage your care outside the National Institutes of Health (NIH).
  • For the healthy family group: Be the mother, father, sibling, or adult child of an enrolled participant.
  • Healthy family members must be 18 to 99 years old, be in good general health, and have no IBD diagnosis.

Who can't join

  • Cannot or do not want to give informed consent, which means agreeing to join after learning about the study.
  • Have a serious illness that the study team thinks could interfere with study tests or procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria: Affected Participant cohort: 1. Adults 18 - 85 years of age 2. History of: 1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and/or 2. a defined genetic syndrome/mutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD 3. Presence of a referring community physician who would be able to manage care outside of NIH Unaffected family member of participant: immediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD 1. Adults 18 - 99 years of age 2. In good general health 3. No medical diagnosis of IBD EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. Unable or unwilling to provide informed consent 2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures

Study sites (1)

MD