Evaluation of People With Gastrointestinal Disease

Evaluation of Patients With Gastrointestinal Disease

Background:

- Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There are many different kinds of these diseases. Clinical trials are being developed to study new ways to treat them. People who are interested in clinical trials need to be screened before they can take part in the studies. Researchers want to evaluate people with different stomach and intestine disorders to see if they are eligible for clinical trials.

Objectives:

- To study people who have gastrointestinal disorders and see if they are eligible for clinical trials.

Eligibility:

- Individuals at least 18 years of age who have or may have a gastrointestinal disorder.

Design:

• Participants will be screened with a physical exam and medical history. Blood, urine, and stool samples will be collected. Imaging studies such as x-rays and ultrasound will check to see if the disorder has affected other organs.
• Participants may have tests as needed depending on their disorder. These tests include the following:
• Colonoscopy and endoscopy of the large intestine, esophagus, and stomach.
• Stomach acid analysis to look at stomach pH levels.
• Wireless capsule endoscopy to take pictures of the small intestine.
• Hydrogen breath testing to study issues like bloating, diarrhea, and constipation.
• Sitz Marker Study to see how fast stool moves through the colon.
• Participants may donate extra blood, urine, or stool samples for study. They may also donate stomach contents or tissue from the gut.
• Treatment will not be provided as part of this study. However, participants may be admitted to other clinical trials.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases

Detailed Description

Patients with suspected or established acute or chronic gastrointestinal diseases are evaluated and treated in this protocol and will be screened for entry into other research protocols. This protocol serves several purposes: 1) allows for detailed inquiry into the gastrointestinal disorders of these patients and the status of other organ systems that would determine their ability to safely enroll in active Digestive Diseases Branch (DDB) research protocols; 2) allows investigators to offer clinical diagnostic testing, procedures, and treatment to patients if clinically indicated to facilitate their participation in clinical trials; 3) allows outpatient evaluation and treatment of patients with a variety of gastrointestinal diseases for the purposes of physician education in our accredited gastroenterology training program; and 4) After completion of the initial evaluation process, patients will either be offered a chance to participate in an active research protocol or, if no appropriate protocol is identified, patients may be seen long-term to follow the disease progression for potential future participation in DDB gastrointestinal studies. Recommendations for other treatment options outside of the NIH will be discussed with study patients and/or to their primary or referring physicians.

• Study Type: Observational
• Enrollment (Actual): 2761

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected gastrointestinal disease.@@@@@@

Description

• INCLUSION CRITERIA:
• Known or suspected gastrointestinal disorders.
• Patients greater than or equal to 18 years of age capable of providing informed consent.
• Existence of a referring community physician who would be able to manage care outside of the NIH.

EXCLUSION CRITERIA:

• Significant medical illnesses that the investigators feel may interfere with potential evaluations.
• 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.

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
Patients with gastrointestinal disease	screening protocol for gastrointestinal diseases.	until protocol closes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allow outpatient evaluation and follow-up of patients with a variety of gastrointestinal diseases for the purposes of physician education in the NIDDK's accredited gastroenterology training program.	evaluation and follow-up of gastrointestinal diseases.	until protocol closes

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): July 27, 2012
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 11, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Natural History; Gastrointestinal Disease; Upper GI Disease; Small Bowel Disease; Digestive Disease; Lower GI Disease
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 120154; 12-DK-0154

Drug and device information, study documents

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