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Sponsor study identifier
Secondary identifiers
observational
132
1 country
1
Study Start
February 6, 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
November 13, 2019
Date type not reportedThis date has not been verified as actual or estimated.
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.) 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 13, 2019
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2009
Actual (reported)January 19, 2009
Actual (reported)February 6, 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 13, 2019
Date type not reportedThis date has not been verified as actual or estimated.
No intervention. Natural history study
Compare abdominal pain and intestinal inflammation in normal weight and overweight individuals.
At enrollment
Natural History study.
At enrollment
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Creed F, Ratcliffe J, Fernandez L, Tomenson B, Palmer S, Rigby C, Guthrie E, Read N, Thompson D. Health-related quality of life and health care costs in severe, refractory irritable bowel syndrome. Ann Intern Med. 2001 May 1;134(9 Pt 2):860-8. doi: 10.7326/0003-4819-134-9_part_2-200105011-00010.
Russo MW, Gaynes BN, Drossman DA. A national survey of practice patterns of gastroenterologists with comparison to the past two decades. J Clin Gastroenterol. 1999 Dec;29(4):339-43. doi: 10.1097/00004836-199912000-00009.
Wendy A Henderson, C.R.N.P.
National Institute of Nursing Research (NINR)
132 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2009
First Posted
January 19, 2009
Study Start
February 6, 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Mayer EA. The neurobiology of stress and gastrointestinal disease. Gut. 2000 Dec;47(6):861-9. doi: 10.1136/gut.47.6.861. No abstract available.
Colina Prisco C, Fourie NH, Wang Y, Steck M, de Jesus Vega M, Graves-Dixon LY, Jaime-Lara RB, Henderson WA, Joseph PV. Examining mRNA-miRNA Interactions and Gene Expression in Overweight and Obesity. Biol Res Nurs. 2026 Jul;28(3):427-444. doi: 10.1177/10998004261433237. Epub 2026 Mar 19.
Joseph PV, Davidson HR, Boulineaux CM, Fourie NH, Franks AT, Abey SK, Henderson WA. Eating Behavior, Stress, and Adiposity: Discordance Between Perception and Physiology. Biol Res Nurs. 2018 Oct;20(5):531-540. doi: 10.1177/1099800418779460. Epub 2018 May 31.
Abey SK, Yuana Y, Joseph PV, Kenea ND, Fourie NH, Sherwin LB, Gonye GE, Smyser PA, Stempinski ES, Boulineaux CM, Weaver KR, Bleck CK, Henderson WA. Lysozyme association with circulating RNA, extracellular vesicles, and chronic stress. BBA Clin. 2016 Dec 20;7:23-35. doi: 10.1016/j.bbacli.2016.12.003. eCollection 2017 Jun.
Del Valle-Pinero AY, Sherwin LB, Anderson EM, Caudle RM, Henderson WA. Altered vasoactive intestinal peptides expression in irritable bowel syndrome patients and rats with trinitrobenzene sulfonic acid-induced colitis. World J Gastroenterol. 2015 Jan 7;21(1):155-63. doi: 10.3748/wjg.v21.i1.155.
Reddy SY, Rasmussen NA, Fourie NH, Berger RS, Martino AC, Gill J, Longchamps R, Wang XM, Heitkemper MM, Henderson WA. Sleep quality, BDNF genotype and gene expression in individuals with chronic abdominal pain. BMC Med Genomics. 2014 Oct 31;7:61. doi: 10.1186/s12920-014-0061-1.
Del Valle-Pinero AY, Martino AC, Taylor TJ, Majors BL, Patel NS, Heitkemper MM, Henderson WA. Pro-inflammatory chemokine C-C motif ligand 16 (CCL-16) dysregulation in irritable bowel syndrome (IBS): a pilot study. Neurogastroenterol Motil. 2011 Dec;23(12):1092-7. doi: 10.1111/j.1365-2982.2011.01792.x. Epub 2011 Sep 23.
Study Completion
November 13, 2019
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
November 20, 2019
Record last verified: 2019-11-13
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