Evaluating and Treating Potential Research Participants With Digestive Disorders

Not Applicable

Terminated

• Conditions: Obesity; Abdominal Pain; Stress; Irritable Bowel Syndrome
• Interventions: Other: Standard of Care

• Registration Number: NCT01736280
• Lead Sponsor: National Institute of Nursing Research (NINR)

Brief Summary

Background:

- Some research studies focus on digestive disorders, such as nutritional, gastrointestinal, and liver disorders. Researchers want to examine and treat people with digestive disorders in order to learn more about these disorders. They also want to study how digestive disorders run in some families. To do so, they will provide standard care to people with digestive disorders. They will also look at relatives of people with digestive disorders, such as parents, children, and siblings.

Objectives:

* To examine and treat people with digestive disorders.

* To evaluate people with digestive disorders for research studies.

Eligibility:

* Individuals of any age who have digestive disorders.

* Individuals at least 2 years of age who are first-degree relatives of the people with digestive disorders.

Design:

* Participants will have at least one outpatient visit to the National Institutes of Health. The visit will last about 2 hours.

* All participants will be screened with a physical exam and medical history. They will also provide different samples for study. Samples may include blood, urine, and stool samples. Saliva and hair samples may also be taken. Skin biopsies and rectal swabs may be collected from adult participants.

* Participants with digestive disorders may be able to receive treatment through this study.

Detailed Description

The National Institute of Nursing Research (NINR) is conducting a protocol to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed digestive conditions. Investigators of this protocol provide GI consultation at the NIH Clinical Center for a range of GI conditions.

Objectives: The primary objective of this protocol is to allow digestive care specialists in NINR and other institutions to provide standard of care. Evaluating and treating participants will allow digestive care specialists to maintain their expertise and gain additional knowledge of the course of various digestive disorders. Additionally this protocol will allow for hypothesis generation and provide a resource of patients for enrollment into new research protocols throughout the NINR branches. The information obtained will allow for the evaluation of standard treatments of the studied digestive diseases. This understanding may lead to ideas for future protocols. The protocol will also allow for trainees to receive training in the management of digestive disorders.

Study Population: The number of participants for this evaluation and treatment protocol will be set to 500 patients with digestive disorders and their unaffected first-degree relatives.

Design: This is a natural history evaluation and treatment protocol of the progression and physiology of multiple digestive disorders. Blood or other biologic samples (including but not limited to stool, urine, saliva, hair, cheek swab, or tissue) will be obtained through non-invasive means or incidentally to clinical care for future laboratory studies. In addition, genetic samples may be collected from unaffected first-degree relatives and may be used to identify and verify causative mutations.

Outcome Measures: The outcome measures for this protocol are the clinical assessments of enrolled participants, including their response to standard treatments. Also, causative mutations may help establish pathogenic mechanisms and genotype-phenotype correlations.

Study Timeline

• Study Start: 2012-09-17
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Status Verified: 2019-11-21
• Primary Completion: 2019-11-21
• Study Completion: 2019-11-21
• Last Update Submitted: 2019-11-23
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Standard of Care	Standard of Care. Participants will be evaluated and treated for their particular digestive disorder or presenting symptoms.

Primary Outcome Measures

Name	Time	Method
Evaluation and treatment of GI disorders	Outcomes will be assessed periodically according to disorder and severity.	This protocol allows NINR investigators to provide treatment for GI disorders and maintain knowledge and expertise of GI disorders.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States