Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Condition(s) targeted: Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; Chronic Abdominal Discomfort

Intervention: Rifaximin (Drug); Lactulose Breath Test (Procedure); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Institutes of Health (NIH)

Official(s) and/or principal investigator(s):
Henry C Lin, MD, Principal Investigator, Affiliation: New Mexico VA Healthcare System

Overall contact:
Lisa R Fowles, BS, Phone: 505-265-1711, Ext: 2286, Email: LFowles@salud.unm.edu

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.

Official title: Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Efficacy Study

Primary outcome: To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT

Secondary outcome: The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

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

Lisa R Fowles, BS, Phone: 505-265-1711, Ext: 2286, Email: LFowles@salud.unm.edu

General Clinical Research Center, Albuquerque, New Mexico 87131, United States; Recruiting
Patsy Lucero, Phone: 505-272-2451

Starting date: August 2007
Last updated: August 10, 2009