Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

NCT ID: NCT00956397

Last Updated: 2012-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31

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.

Conditions

Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; Chronic Abdominal Discomfort

Keywords

Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; chronic abdominal discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control Participants

Group Type: ACTIVE_COMPARATOR

Lactulose Breath Test

Intervention Type: PROCEDURE

Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).

FD Participants

Group Type: ACTIVE_COMPARATOR

Rifaximin

Intervention Type: DRUG

rifaximin 550 mg TID PO x 10 days

Lactulose Breath Test

Intervention Type: PROCEDURE

Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).

FD (Placebo) Participants

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo TID x 10 days

Interventions

Rifaximin

rifaximin 550 mg TID PO x 10 days

Intervention Type: DRUG

Lactulose Breath Test

Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).

Intervention Type: PROCEDURE

Placebo

placebo TID x 10 days

Intervention Type: DRUG

Other Intervention Names

Xifaxan

Eligibility 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
• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry C. Lin, MD

FED

Sponsor Role: lead

Responsible Party

Henry C. Lin, MD

Henry C. Lin, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Henry C Lin, MD

Role: PRINCIPAL_INVESTIGATOR

New Mexico VA Healthcare System

Locations

General Clinical Research Center

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

5R21DK078101-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HRRC 07-187

Identifier Type: -

Identifier Source: org_study_id