Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, Chronic Abdominal Discomfort
Conditions
Keywords
Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, chronic abdominal discomfort
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.
Interventions
DRUGRifaximin
rifaximin 550 mg TID PO x 10 days
PROCEDURELactulose 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).
DRUGPlacebo
placebo TID x 10 days
Sponsors
Henry C. Lin, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment | 2 weeks |
Countries
United States
Outcome results
None listed