| Conditions: |
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Obesity - Stress - Irritable Bowel Syndrome |
| Purpose: |
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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
provide a blood sample for testing. Researchers will measure patients' blood pressure and
heart rate, height, weight, waist/hip circumference, and intra-abdominal measurement.
Patients will also be asked to put on the bathing suit and swim cap to have their body fat
measured using a machine called the BOD POD. To test the gastrointestinal system, patients
will then be asked to drink a sugar-based test solution, and researchers will collect all
voided urine for the next 5 to 6 hours. (Patients may drink water during this time.)
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| Study Summary: |
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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 research will test the hypothesis that chronic abdominal pain of unknown
etiology has an inflammatory mechanism. Although increased body weight may be associated
with increased inflammation, it is unclear that increased body weight is associated with
chronic abdominal pain. Accordingly both overweight and normal weight subjects with and
without chronic abdominal pain of unknown origin will be included in this study. The study
design is a longitudinal natural history.
The purpose is to test the relationship between abdominal pain symptoms and intestinal
inflammation in two groups (overweight and normal weight patients with chronic abdominal
pain of unknown origin). After obtaining informed consent, an initial screening history and
physical exam to ensure eligibility will be preformed. The participants' abdominal pain,
psychological distress, quality of life, socio-demographic, and co-morbidities will be
assessed via questionnaires. Anthropometry, vital signs, and fasting blood work will be
drawn at both of the two visits to the Clinical Center of the National Institutes of Health
for clinical screening labs and research purposes.
There are three measures of intestinal inflammation including fecal calprotectin, intestinal
permeability, and serum cytokine IL-6 levels. A stool sample will be collected to measure
fecal calprotectin. Intestinal permeability will be measured with the administration of a
sugar based test solution which will be given orally to participants after an overnight fast
on their second visit. Excreted urine sugar ratios, expressed per m2 of body surface area,
will measure gastrointestinal permeability. Body mass and body fat analysis
(plethysmography), intra-abdominal and liver ultrasound, and Fibroscan measures will also be
collected on visit two.
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| Criteria: |
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- 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
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| NCT ID: |
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NCT00824941 |
| Primary Contact: |
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Principal Investigator
Wendy A Henderson, C.R.N.P.
National Institute of Nursing Research (NINR)
Angela C Martino, R.N.
Phone: (301) 443-4693
Email: martinoa@mail.nih.gov
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| Backup Contact: |
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Email: hendersw@mail.nih.gov
Wendy A Henderson, C.R.N.P.
Phone: (301) 451-9534
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |