NIH Clinical Research Studies

Protocol Number: 09-NR-0064

Active Accrual, Protocols Recruiting New Patients

Brain-Gut Interactions in Overweight and Normal Weight Patients with Chronic Abdominal Pain
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 design.

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 day two.

Sponsoring Institute:
National Institute of Nursing Research (NINR)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility 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


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

Special Instructions:
Currently Not Provided
Abdominal Pain
Women's Health and Disease
Recruitment Keyword(s):
Irritable Bowel Syndrome
Investigational Drug(s):
Investigational Device(s):
Supporting Site:
National Institutes of Nursing Research

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793


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.

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.

Mayer EA. The neurobiology of stress and gastrointestinal disease.Gut. 2000 Dec; 47(6):861-9.

Active Accrual, Protocols Recruiting New Patients

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