ObesityNCT00824941
Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain
An observational study of Obesity and Stress, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Stress, Irritable Bowel Syndrome
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2009to 13 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Obesity, Stress, Irritable Bowel Syndrome, Women, Abdominal Pain
- Keywords
- Abdominal Pain, Women's Health and Disease, Inflammation, Symptoms, Brain, Chronic Abdominal Pain
- Medical subject headings
- Obesity, Irritable Bowel Syndrome, Abdominal Pain, Disease, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
No intervention. Natural history study
Compare abdominal pain and intestinal inflammation in normal weight and overweight individuals.
Measured: At enrollment
Secondary outcomes (1)
Natural History study.
Characterize association between abdominal pain and inflammatory markers.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study start6 Feb 2009
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Wendy A Henderson, C.R.N.P., Principal investigator, National Institute of Nursing Research (NINR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824941
- Sponsor's protocol ID
- 090064
- Other IDs
- 09-NR-0064
- Status last verified
- 13 Nov 2019
- First submitted
- 16 Jan 2009
- Last updated
- 20 Nov 2019
- Results posted
- No
Publications
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.
PubMed 11346322Russo 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.
PubMed 10599638Mayer 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.
PubMed 11076888Colina 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.
PubMed 41854421Joseph 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.
PubMed 29852756Abey 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.
PubMed 28053879Del 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.
PubMed 25574088Reddy 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.
PubMed 25358868Del 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.
PubMed 21951809
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Gut Interactions in Overweight and Normal Weight Patients With Chronic Abdominal Pain
- ClinicalTrials.gov ID
- NCT00824941
- Acronym / sponsor ID
- 090064
- Conditions
- Obesity, Stress, Irritable Bowel Syndrome, Women, Abdominal Pain
- Keywords
- Abdominal Pain, Women's Health and Disease, Inflammation, Symptoms, Brain, Chronic Abdominal Pain
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 132 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- 6 Feb 2009
- Study completion
- 13 Nov 2019
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
No intervention. Natural history study
Time frame: At enrollment
Compare abdominal pain and intestinal inflammation in normal weight and overweight individuals.
1 secondary outcome
Natural History study.
Time frame: At enrollment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Background: PubMed 11346322Creed 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.
- Background: PubMed 10599638Russo 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.
- Background: PubMed 11076888Mayer 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.
- Derived from this study: PubMed 41854421Colina 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.
- Derived from this study: PubMed 29852756Joseph 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.
- Derived from this study: PubMed 28053879Abey 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.
- Derived from this study: PubMed 25574088Del 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.
- Derived from this study: PubMed 25358868Reddy 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.
- Derived from this study: PubMed 21951809Del 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy A Henderson, C.R.N.P. principal investigator
National Institute of Nursing Research (NINR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Stress, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No intervention. Natural history study (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00824941, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.