Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain
TerminatedNCT00824941
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 abdominal pain is an inflammation of the intestines, but it is not known whether the two are related. Furthermore, although overweight people tend to be more likely to have increased inflammation, it is not known whether there is a connection between increased body weight and chronic abdominal pain. This study will examine the relationship between symptoms of chronic abdominal pain and intestinal inflammation by comparing the medical test results of normal weight and overweight patients who have a history of chronic abdominal pain. This study will include 224 subjects, who must be men and women between the ages of 13 and 45. Half the subjects will be healthy participants, and half will have had chronic abdominal pain of unknown origin for longer than 6 months. Female participants must take a urine pregnancy test before starting the study, and will not be allowed to participate if the test is positive. During the study, patients will visit the NIH Clinical Center on two occasions for testing. On the first visit, patients will provide a medical history, including information about current medications or natural remedies and tobacco and alcohol use, and will also fill out questionnaires to provide information about symptoms, current levels of gastrointestinal pain, and general quality of life. The study researchers will conduct a physical examination, measure patients height and weight, and draw blood for testing. Patients will be asked to not eat or drink anything for 8 hours before the second visit, and will be asked to bring a bathing suit and a swim cap to the Clinical Center. On the day of the visit, patients will fill out questionnaires to provide information about symptoms, current levels of gastrointestinal pain, and general quality of life. Patients will also provid…
Study details
- Official title
- Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain
- Conditions
- Sponsor
- National Institute of Nursing Research (NINR)
- Organization
- National Institutes of Health Clinical Center (CC)
- Start date
- 2009-02-06
- Sex
- All
- Age range
- from 13 Years to 45 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00824941