Evaluation of Patients With Gastrointestinal Disease

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....

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Diseases; Lower GI Disease

Detailed Description

Patients with suspected or established acute or chronic gastrointestinal diseases or who require clinical screening for gastrointestinal diseases are provided standard clinical care for their condition. Data and samples obtained during regular clinical care will be retained for future research in gastrointestinal diseases. Recommendations for other treatment options outside of the NIH will be discussed with study patients and may be discussed with their primary or referring physicians.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Beverly E Niles; Phone Number: (301) 451-0659; Email: beverly.niles@nih.gov
• Study Contact Backup: Name: Sheila Kumar, M.D.; Phone Number: (301) 496-9730; Email: sheila.kumar@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY8664111010 800-411-1222; Email: prpl@cc.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected gastrointestinal disease.

Description

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Cohort; Patients with known or suspected gastrointestinal disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Sheila Kumar, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 15, 2024

More Information

Terms related to this study

• Keywords: Natural History; Gastrointestinal Diseases; Digestive System Diseases; Upper GI Disease; Small Bowel Disease
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 10000247; 000247-DK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No