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Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry C. Lin, MD, New Mexico VA Healthcare System
ClinicalTrials.gov Identifier:
NCT00956397
First received: August 10, 2009
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
Chronic Abdominal Discomfort
 Drug: Rifaximin
Procedure: Lactulose Breath Test
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Gas Indigestion
U.S. FDA Resources

Further study details as provided by New Mexico VA Healthcare System:

Primary Outcome Measures:
  • To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT [ Time Frame: every 15 minutes for 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: August 2007
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: Rifaximin
rifaximin 550 mg TID PO x 10 days
Other Name: Xifaxan
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).
Placebo Comparator: FD (Placebo) Participants Drug: Placebo
placebo TID x 10 days

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956397

Locations
United States, New Mexico
General Clinical Research Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
Henry C. Lin, MD
Investigators
Principal Investigator: Henry C Lin, MD New Mexico VA Healthcare System
  More Information

No publications provided

Responsible Party: Henry C. Lin, MD, New Mexico VA Healthcare System
ClinicalTrials.gov Identifier: NCT00956397     History of Changes
Other Study ID Numbers: HRRC 07-187, 5R21DK078101-02
Study First Received: August 10, 2009
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New Mexico VA Healthcare System:
Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
chronic abdominal discomfort

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Stomach Diseases
Rifaximin
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013