Clinical trial Recruiting at 1 site Observational Ages 18 to 120

Evaluation of patients with gastrointestinal diseases

Official title: Evaluation of Patients With Gastrointestinal Disease

Run by National Institutes of Health Clinical Center (CC) · NCT05041374 · Data updated 2026-11-12

This study is collecting health information and samples from adults with gut problems to help improve understanding and treatment of these conditions in the future.

Quick facts

Study typeObservational
Ages18 Years to 120 Years
SexAll
Enrollment4000 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedJanuary 4, 2022
Main results expectedDecember 31, 2035
Study endsDecember 31, 2035
Registry record updatedNovember 4, 2026
Trial IDNCT05041374 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with known or suspected gastrointestinal disorders requiring clinical screening or treatment.

Probably not a fit

Patients with significant medical illnesses that may interfere with evaluations or those without a referring physician may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to collect clinical data and biological samples from adults with known or suspected gastrointestinal disorders who are receiving treatment at the NIH. Participants will undergo standard clinical care, including physical exams and medical record reviews, while their data and samples will be retained for future research on gastrointestinal diseases. The goal is to enhance understanding and treatment of these conditions through ongoing and future research projects.

Why it matters

Potential benefit: If successful, this study could lead to improved assessment and treatment options for patients with gastrointestinal diseases.

How similar studies have gone: Other studies focusing on the natural history and biological sampling of gastrointestinal diseases have shown promise, indicating that this approach is supported by prior research.

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Male or female, aged \>= 18 years of age
2. Known or suspected gastrointestinal disorders or requiring clinical screening, management and/or treatment and follow-up per current American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE) or the American Association for the Study of Liver Disease (AASLD).

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Significant medical illnesses that the investigators feel may interfere with potential evaluations.
2. Absence of a referring community physician who would be able to manage care outside of the NIH.
3. Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient.
4. Inability to provide informed consent.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Sheila Kumar, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Study coordinator: Gladys L Salas
  • Email: gladys.salas@nih.gov
  • Phone: (301) 594-0636

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.