Recruiting

Observational Study

Sponsor:

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

Code:

NCT05041374

Conditions

Lower GI Disease

Gastrointestinal Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05041374

Start date

Jan 4, 2022

Status verified date

Jul 30, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Cohort

Patients with known or suspected gastrointestinal disease

Primary outcome measure

  • To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of gastrointestinal diseases. [ Time Frame: End of study ]

Central Contacts and Locations

Central contacts

Beverly E Niles

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

Sheila Kumar, M.D.

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

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

Last update posted

Aug 10, 2026

Last verified

Jul 30, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2026-08-10.