Evaluating and Treating Potential Research Participants With Digestive Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01736280
First received: November 27, 2012
Last updated: July 2, 2014
Last verified: June 2014
  Purpose

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.

Condition
Stress
Irritable Bowel Syndrome
Obesity
Abdominal Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation and Treatment Protocol for Potential Research Participants With Digestive Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: August 2012
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

This protocol will include participants from birth and has no upper age limit.

Participants will be eligible if they:

  1. Have either a digestive disorder, OR
  2. Are an unaffected first-degree relative ( > 2 years old) of a participant with a digestive disorder.

EXCLUSION CRITERIA:< TAB>

Participants will not be eligible if they:

  1. Are unwilling to give informed consent or, if a minor, do not have a parent or guardian able to provide consent
  2. Have a systemic disease that, in the judgment of the investigators, compromises the ability to obtain research data.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736280

Contacts
Contact: LeeAnne B Sherwin, C.R.N.P. (301) 451-9534 leeanne.sherwin@nih.gov
Contact: Wendy A Henderson, C.R.N.P. (301) 451-9534 hendersw@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Wendy A Henderson, C.R.N.P. National Institute of Nursing Research (NINR)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01736280     History of Changes
Other Study ID Numbers: 120195, 12-NR-0195
Study First Received: November 27, 2012
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Symptoms
Immunogenetics
Digestive Disorders
Gastrointestinal

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Abdominal Pain
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 16, 2014