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Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

Primary Purpose

Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, Chronic Abdominal Discomfort

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Lactulose Breath Test
Placebo
Sponsored by
Henry C. Lin, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, chronic abdominal discomfort

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Control Participants

FD Participants

FD (Placebo) Participants

Arm Description

Outcomes

Primary Outcome Measures

To compare the pattern of bacterial gas excretion in breath among Veterans with FD vs. controls using LBT

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2009
Last Updated
October 22, 2012
Sponsor
Henry C. Lin, MD
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1. Study Identification

Unique Protocol Identification Number
NCT00956397
Brief Title
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
Official Title
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henry C. Lin, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, Chronic Abdominal Discomfort
Keywords
Functional Dyspepsia, Small Intestinal Bacterial Overgrowth, chronic abdominal discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Participants
Arm Type
Active Comparator
Arm Title
FD Participants
Arm Type
Active Comparator
Arm Title
FD (Placebo) Participants
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Xifaxan
Intervention Description
rifaximin 550 mg TID PO x 10 days
Intervention Type
Procedure
Intervention Name(s)
Lactulose Breath Test
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo TID x 10 days
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The investigators will determine the relationship between SIBO in FD patients using randomized antibiotic treatment
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry C Lin, MD
Organizational Affiliation
New Mexico VA Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

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Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

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