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Evaluating and Treating Potential Research Participants With Digestive Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01736280
Recruitment Status : Recruiting
First Posted : November 29, 2012
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):

November 27, 2012
November 29, 2012
January 18, 2018
August 30, 2012
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Evaluation and treatment training protocol [ Time Frame: ongoing ]
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Complete list of historical versions of study NCT01736280 on ClinicalTrials.gov Archive Site
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Evaluating and Treating Potential Research Participants With Digestive Disorders
Evaluation and Treatment Protocol for Potential Research Participants With Digestive Disorders


- 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.


  • To examine and treat people with digestive disorders.
  • To evaluate people with digestive disorders for research studies.


  • 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.


  • 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.

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.

Time Perspective: Prospective
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  • Stress
  • Irritable Bowel Syndrome
  • Obesity
  • Abdominal Pain
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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.


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, cannot assign a Durable Power of Attorney (DPA) 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.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact: Shavonne N Pocock (301) 443-4693 shavonne.pocock@nih.gov
Contact: Wendy A Henderson, C.R.N.P. (301) 451-9534 hendersw@mail.nih.gov
United States
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National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
National Institute of Nursing Research (NINR)
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Principal Investigator: Wendy A Henderson, C.R.N.P. National Institute of Nursing Research (NINR)
National Institutes of Health Clinical Center (CC)
April 28, 2017