Clinical trial NCT00956397: Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
Official title: Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
Chronic Abdominal Discomfort
Keywords: Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
chronic abdominal discomfort
Lead sponsor: New Mexico VA Healthcare System
Sponsor class: FED
First posted: 2009-08-11
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT
timeFrame: every 15 minutes for 180 minutes
Secondary outcomes:
measure: The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: General Clinical Research Center
state: New Mexico
Study officials:
affiliation: New Mexico VA Healthcare System
name: Henry C Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: