Evaluating and Treating Potential Research Participants With Digestive Disorders

Tracking Information
First Submitted Date	November 27, 2012
First Posted Date	November 29, 2012
Last Update Posted Date	May 9, 2018
Study Start Date	August 30, 2012
Primary Completion Date	Not Provided
Current Primary Outcome Measures; (submitted: June 2, 2016)	Evaluation and treatment training protocol [ Time Frame: ongoing ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01736280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Evaluating and Treating Potential Research Participants With Digestive Disorders
Official Title	Evaluation and Treatment Protocol for Potential Research Participants With Digestive Disorders
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 Type	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Stress; Irritable Bowel Syndrome; Obesity; Abdominal Pain
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: November 27, 2012)	500
Original Estimated Enrollment	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria	INCLUSION CRITERIA: This protocol will include participants from birth and has no upper age limit. Participants will be eligible if they: Have either a digestive disorder, OR; 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: 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.; Have a systemic disease that, in the judgment of the investigators, compromises the ability to obtain research data.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	Yes
Contacts	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
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT01736280
Other Study ID Numbers	120195; 12-NR-0195
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
Study Sponsor	National Institute of Nursing Research (NINR)
Collaborators	Not Provided
Investigators	Principal Investigator: Wendy A Henderson, C.R.N.P. National Institute of Nursing Research (NINR)
PRS Account	National Institutes of Health Clinical Center (CC)
Verification Date	May 2, 2018