Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

NCT00956397 | Completed DMC

• 2 other identifiers: HRRC 07-1875R21DK078101-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; Chronic Abdominal Discomfort

Keywords

Functional Dyspepsia; Small Intestinal Bacterial Overgrowth; chronic abdominal discomfort

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment

  2 weeks

Study Arms (3)

Control Participants

ACTIVE COMPARATOR

Procedure: Lactulose Breath Test

FD Participants

ACTIVE COMPARATOR

Drug: Rifaximin; Procedure: Lactulose Breath Test

FD (Placebo) Participants

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rifaximin DRUG

rifaximin 550 mg TID PO x 10 days

Also known as: Xifaxan

FD Participants

Lactulose Breath Test PROCEDURE

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).

Control Participants; FD Participants

Placebo DRUG

placebo TID x 10 days

FD (Placebo) Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of IBS,rheumatoid arthritis,H. Pylori infection,lupus,peptic ulcer, cirrhosis,diabetes, HIV or TB
• Inflammatory bowel disease
• 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

Sponsors & Collaborators

• Henry C. Lin, MD: lead

Study Sites (1)

General Clinical Research Center

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Henry C Lin, MD

  New Mexico VA Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Henry C. Lin, MD

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: August 1, 2007
• Primary Completion: March 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

US (1)