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OpenTrials
Completed

NCT Number: NCT00956397

Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

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.

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Key information

Conditions

Functional Dyspepsia Chronic Abdominal Discomfort Small Intestinal Bacterial Overgrowth

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Clinical Research Center

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

rifaximin 550 mg TID PO x 10 days

Other names: Xifaxan

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).

Placebo

Drug

placebo TID x 10 days

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Henry C. Lin, MD

Fed

Registry information

Important dates

Study start
2007
Primary completion
2012
First posted
Aug 11, 2009
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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