Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Henry C. Lin, MD

Status: Completed

Conditions: Chronic Abdominal Discomfort; Functional Dyspepsia; Small Intestinal Bacterial Overgrowth

Treatments: Drug: Placebo; Procedure: Lactulose Breath Test; Drug: Rifaximin

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00956397

5R21DK078101-02 (U.S. NIH Grant/Contract)

HRRC 07-187

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 3 patient groups, including a placebo group

Control Participants

Active Comparator group

Treatment:

Procedure: Lactulose Breath Test

FD Participants

Active Comparator group

Treatment:

Drug: Rifaximin

Procedure: Lactulose Breath Test

FD (Placebo) Participants

Placebo Comparator group

Treatment:

Drug: Placebo