Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Not Applicable

Completed

• Conditions: Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; Chronic Abdominal Discomfort
• Interventions: Drug: Placebo; Drug: Rifaximin; Procedure: Lactulose Breath Test

• Registration Number: NCT00956397
• Lead Sponsor: Henry C. Lin, MD

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2012-03
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FD Participants	Lactulose Breath Test	-
FD (Placebo) Participants	Placebo	-
Control Participants	Lactulose Breath Test	-
FD Participants	Rifaximin	-

Primary Outcome Measures

Name	Time	Method
To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT	every 15 minutes for 180 minutes

Secondary Outcome Measures

Name	Time	Method
The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment	2 weeks

Trial Locations

Locations (1)

General Clinical Research Center; 🇺🇸 Albuquerque, New Mexico, United States