Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Study Overview
=================
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.

Official Title
-----------------
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, Chronic Abdominal Discomfort

Intervention / Treatment
-----------------
* Drug: Rifaximin
* Procedure: Lactulose Breath Test
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Participants<br> | Procedure: Lactulose Breath Test<br>* 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).<br>|
| Active Comparator: FD Participants<br> | Drug: Rifaximin<br>* rifaximin 550 mg TID PO x 10 days<br>* Other names: Xifaxan;Procedure: Lactulose Breath Test<br>* 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).<br>|
| Placebo Comparator: FD (Placebo) Participants<br> | Drug: Placebo<br>* placebo TID x 10 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, chronic abdominal discomfort