Evaluation of Patients With Gastrointestinal Disease

NCT05041374 | Recruiting

• 2 other identifiers: 10000247000247-DK
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future. Objective: To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research. Eligibility: Adults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines. Design: Participants will be screened with a physical exam. Their medical records will be reviewed. Participants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research. Participants may give blood, urine, and/or stool samples. If participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and/or tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use. Data will be stored at NIH. The data systems are password protected. Samples will be coded. Participants will take part in the study for as long as they agree to be seen for their disease....

Conditions

Lower GI Disease; Gastrointestinal Diseases

Keywords

Digestive System Diseases; Gastrointestinal Diseases; Small Bowel Disease; Upper GI Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of gastrointestinal diseases.

  Development of a data set comprised of results and observations obtained during standard clinical care of patients with known or suspected gastrointestinal disease and collection of samples to be used for future research.

  End of study

Study Arms (1)

Study Cohort

Patients with known or suspected gastrointestinal disease

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected gastrointestinal disease.

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Male or female, aged \>= 18 years of age
• 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).

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Significant medical illnesses that the investigators feel may interfere with potential evaluations.
• Absence of a referring community physician who would be able to manage care outside of the NIH.
• 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.
• Inability to provide informed consent.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sheila Kumar, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beverly E Niles

CONTACT

(301) 451-0659; beverly.niles@nih.gov

Sheila Kumar, M.D.

CONTACT

(301) 496-9730; sheila.kumar@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 13, 2021
• Study Start: January 4, 2022
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 14, 2026

Record last verified: 2026-05-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)