Ignite Creation Date:
2024-05-05 @ 9:09 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00824941
Status:
TERMINATED
Last Update Posted:
2019-11-20
First Post:
2009-01-16
Brief Title:
Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain
Status:
TERMINATED
Status Verified Date:
2019-11-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 waisthip 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
On either Day 1 or Day 2 of the study patients will sip swish and spit an additional sweet taste solution Patients will sip swish and spit different concentrations of this sweet taste solution for a total of 25 tastings of this solution Subjects will then complete questionnaires about their sweetness preferences related to these 25 tastings
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 waisthip 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
On either Day 1 or Day 2 of the study patients will sip swish and spit an additional sweet taste solution Patients will sip swish and spit different concentrations of this sweet taste solution for a total of 25 tastings of this solution Subjects will then complete questionnaires about their sweetness preferences related to these 25 tastings
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 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 performed 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 On either Day 1 or Day 2 of the study patients will sip swish and spit additional sweet taste solutions and complete questionnaires about their sweetness preferences related to these tastings
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 performed 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 On either Day 1 or Day 2 of the study patients will sip swish and spit additional sweet taste solutions and complete questionnaires about their sweetness preferences related to these tastings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 09-NR-0064 | None | None | None |