Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia - Full Text View

Sponsor:	National Institutes of Health (NIH)
Information provided by:	New Mexico VA Healthcare System
ClinicalTrials.gov Identifier:	NCT00956397

Purpose

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.

Condition	Intervention
Functional Dyspepsia Small Intestinal Bacterial Overgrowth Chronic Abdominal Discomfort	Drug: Rifaximin Procedure: Lactulose Breath Test Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Efficacy Study
Official Title:	Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Resource links provided by NLM:

MedlinePlus related topics: Indigestion Nausea and Vomiting

Drug Information available for: Rifaximin Lactulose

U.S. FDA Resources

Further study details as provided by New Mexico VA Healthcare System:

Primary Outcome Measures:

To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT [ Time Frame: every 15 minutes for 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2007
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
FD and Controls: Active Comparator	Procedure: Lactulose Breath Test
53 patients with FD: Active Comparator	Drug: Rifaximin rifaximin 550 mg TID PO x 10 days
27 patients with FD: Placebo Comparator	Drug: Placebo placebo TID x 10 days

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956397

Contacts

Contact: Lisa R Fowles, BS	505-265-1711 ext 2286	LFowles@salud.unm.edu
Contact: Henry C Lin, MD	505-265-1711 ext 4511	helin@salud.unm.edu

Locations

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

Sponsors and Collaborators

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Henry C Lin, MD

New Mexico VA Healthcare System

More Information

No publications provided

Responsible Party:	New Mexico VA Healthcare System ( Henry C. Lin, MD )
Study ID Numbers:	HRRC 07-187, 5R21DK078101-02
Study First Received:	August 10, 2009
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00956397 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by New Mexico VA Healthcare System:

Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
chronic abdominal discomfort

Additional relevant MeSH terms:

Anti-Infective Agents
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Gastrointestinal Agents
Dyspepsia
Pharmacologic Actions
Signs and Symptoms

Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Rifaximin
Gastroenteritis
Gastritis

ClinicalTrials.gov processed this record on February 08, 2010