Status:
TERMINATED
Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Obesity
Stress
Eligibility:
All Genders
13-45 years
Brief Summary
About 15 to 20 percent of individuals living in the United States have chronic abdominal pain, often of unknown origin, which is often difficult to diagnose and treat. One possible cause of chronic ab...
Detailed Description
The objective of this natural history study is to assess the specific gastrointestinal (GI) symptoms and pathophysiology of chronic abdominal pain of unknown origin at the molecular level. This resear...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be included, patients must meet all of the following:
- Have a history of abdominal pain for greater than 6 months
- Males ages 13-45 years old or females ages 13-45 years old who have had their menses for at least 2 years
- Provide written informed consent, prior to entering the study or undergoing any study procedures
- EXCLUSION CRITERIA:
- Patients with any of the following will be excluded:
- Have a history of an organic GI disease (e.g., inflammatory bowel disease, celiac disease, biliary disorders, bowel resection) cardiac, pulmonary, neurologic, renal, endocrine, or gynecological pathology
- Are currently taking medications for GI symptoms daily such as 5-HT3 antagonists/5-HT4 agonists, prokinetic drugs, laxatives (but not fiber supplements), anti-diarrheals or antispasmodics
- Are currently taking other medications daily that would alter serotonin (e.g., serotonin specific reuptake inhibitors \[SSRI\]), catecholamines (e.g., tricycle antidepressants but not inhaled beta-agonist for mild-moderate asthma), cortisol (excluding inhaled corticosteroids)
- Work during the late evening and night (as cortisol levels may be altered)
- Severe co-morbid pain or psychiatric conditions (e.g., fibromyalgia, bipolar or psychotic disorder)
- Take greater than 300 mg of caffeine containing beverages or food (e.g. chocolate) in the afternoon-evening or greater than 2 servings of alcohol containing beverages everyday (decaffeinated coffee is acceptable)
- Are unable to give informed consent
- Are unable to physically use the touch screen for the purpose of the study
- Are visually impaired or currently institutionalized
- Females who are pregnant or lactating
- NINR employees, subordinates/relatives/ or co-workers
- Any NIH employee who is a subordinate/relative/or co-worker of a study investigator
Exclusion
Key Trial Info
Start Date :
February 6 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 13 2019
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00824941
Start Date
February 6 2009
End Date
November 13 2019
Last Update
November 20 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892