Status:
COMPLETED
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
Lead Sponsor:
Henry C. Lin, MD
Conditions:
Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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. Post...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00956397
Start Date
August 1 2007
Last Update
October 24 2012
Active Locations (1)
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1
General Clinical Research Center
Albuquerque, New Mexico, United States, 87131