Evaluation of patients with gastrointestinal diseases
Evaluation of Patients With Gastrointestinal Disease
National Institutes of Health Clinical Center (CC) · NCT05041374
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 type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05041374 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known or suspected gastrointestinal disorders requiring clinical screening or treatment.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- 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: Beverly E Niles
- Email: beverly.niles@nih.gov
- Phone: (301) 451-0659
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lower GI Disease, Gastrointestinal Diseases, Digestive System Diseases, Small Bowel Disease, Upper GI Disease, Natural History