Evaluating and Treating Potential Research Participants With Digestive Disorders

NCT01736280 | Terminated

• 2 other identifiers: 12019512-NR-0195
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Irritable Bowel Syndrome; Obesity; Abdominal Pain

Keywords

Symptoms; Immunogenetics; Digestive Disorders; Gastrointestinal

Outcome Measures

Primary Outcomes (1)

• Evaluation and treatment of GI disorders

  This protocol allows NINR investigators to provide treatment for GI disorders and maintain knowledge and expertise of GI disorders.

  Outcomes will be assessed periodically according to disorder and severity.

Study Arms (1)

1

OTHER

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

Other: Standard of Care

Interventions

Standard of Care OTHER

Any evaluation or treatment under this protocol will be based on standard practice as related to the subjects's digestive disorder.These include but are not limited to biobehavioral interventions including bowel retraining, biofeedback, and other lifestyle interventions, all of which have been shown to be beneficial in the treatment of this type of chronic functional bowel disorder.

1

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• NINR employees, subordinates/relatives/ or co-workers
• Any NIH employess who is a subordinate/relative/or co-worker of a study investigator

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Obesity; Abdominal Pain; Digestive System Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Wendy A Henderson, C.R.N.P.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: September 17, 2012
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11-21

Locations

US (1)