Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

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 Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; Chronic Abdominal Discomfort
• Intervention / Treatment: Procedure: Lactulose Breath Test; Drug: Rifaximin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • General Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Participants	Procedure: 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).
ACTIVE_COMPARATOR: FD Participants	Procedure: 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).; Drug: Rifaximin; rifaximin 550 mg TID PO x 10 days; Other Names: Xifaxan
PLACEBO_COMPARATOR: FD (Placebo) Participants	Drug: Placebo; placebo TID x 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment	2 weeks

Collaborators and Investigators

• Sponsor: Henry C. Lin, MD
• Investigators: Principal Investigator: Henry C Lin, MD, New Mexico VA Healthcare System

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: August 10, 2009
• First Submitted That Met QC Criteria: August 10, 2009
• First Posted (ESTIMATE): August 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 24, 2012
• Last Update Submitted That Met QC Criteria: October 22, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; chronic abdominal discomfort
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Lactulose
• Other Study ID Numbers: HRRC 07-187; 5R21DK078101-02 (NIH)