Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956397
• Other study ID #: HRRC 07-187
• Secondary ID: 5R21DK078101-02
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: October 22, 2012
• Start date: August 2007

Study information

• Verified date: October 2012
• Source: New Mexico VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Abdominal Discomfort
• Dyspepsia
• Functional Dyspepsia
• Gastritis
• Small Intestinal Bacterial Overgrowth

Intervention

Drug:
• Rifaximin
rifaximin 550 mg TID PO x 10 days

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:
• Placebo
placebo TID x 10 days

Locations

Country	Name	City	State
United States	General Clinical Research Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Henry C. Lin, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT		every 15 minutes for 180 minutes	No
Secondary	The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment		2 weeks	No