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Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia - NCT00956397-87131(Clinical Trial 305350)



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City:  Albuquerque
State:  
NM
Zip Code: 87131
Conditions: Functional Dyspepsia - Small Intestinal Bacterial Overgrowth - Chronic Abdominal Discomfort
Purpose: The prevalence of functional dyspepsia (FD) is estimated to be 15% of the adult population. FD is commonly described as a condition of chronic abdominal discomfort localized to the upper abdomen. Postprandial bloating, pain, nausea, vomiting, belching, and early satiety are common symptoms of the FD patient. FD is defined by >12 weeks of symptoms, which need not be consecutive, within the preceding year consisting of a) persistent or recurrent dyspepsia and b) an absence of organic disease after a gastrointestinal endoscopy or x-ray series. FD is therefore considered a disorder of function because no mucosal pathology is seen in these patients, as in patients with other functional disorders such as irritable bowel syndrome (IBS) and fibromyalgia (FM). There is a remarkable degree of overlap among these three disorders. These 3 disorders share the finding of hypersensitivity and the symptom of postprandial bloating to suggest the possibility of a common origin.
Study summary:
Criteria: Inclusion Criteria: - Must have FD based on the most recent Umbrella criteria of one or more of: a. bothersome postprandial fullness, b. early satiation, c. epigastric pain, d. epigastric burning - No evidence of organic disease (including H. pylori detected at time of endoscopy) that is likely to explain the symptoms - Criteria must be fulfilled for the last 3 months with symptom onset at least 6 months before the diagnosis - The physical exam, routine blood tests including CBC, chemistry panel and liver tests, upper gastrointestinal endoscopy and 24h pH study must be normal Exclusion Criteria: - History of IBS,rheumatoid arthritis,H. Pylori infection,lupus,peptic ulcer, cirrhosis,diabetes, HIV or TB - Inflammatory bowel disease - Bowel Resection (including gastric, small bowel or colon; gallbladder surgery or appendectomy are NOT exclusion criteria) - Anti/pro-biotics last 3 months - Previous LBT (Lactulose Breath Test) - Narcotic Dependence - Pregnancy - Control subjects will be excluded if they have symptoms of heartburn, retrosternal chest pain, chronic cough, nausea or regurgitation suggestive of gastroesophageal reflux disease
Study is available at: General Clinical Research Center
Albuquerque, NM 87131
United States

Primary Contact:
Patsy Lucero
Phone: 505-272-2451

Secondary Contact:
Lisa R Fowles, BS
Email: LFowles@salud.unm.edu
Phone: 505-265-1711
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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