Evaluation of People With Gastrointestinal Disease

NCT01639924 | Completed

• 2 other identifiers: 12015412-DK-0154
• Study Type: observational
• Target: 2,761
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Diseases

Keywords

Upper GI Disease; Small Bowel Disease; Digestive Disease; Gastrointestinal Disease; Lower GI Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• Patients with gastrointestinal disease

  screening protocol for gastrointestinal diseases.

  until protocol closes

Secondary Outcomes (1)

• 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.

  until protocol closes

Study Arms (1)

Study Cohort

Patients with known or suspected gastrointestinal disease

Eligibility Criteria

• Age: 18 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

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

Study Design

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

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: July 27, 2012
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

US (1)