Does Small Intestinal Bacterial Overgrowth Contribute to... | NCT00956397

Studies
Does Small Intestinal Bacterial Overgrowth Contribute to Functional Dyspepsia

NCT00956397

Sponsor

Henry C. Lin, MD

Status

Completed

Last Update Posted

Oct 24, 2012Estimated

Enrollment

55Actual

Phase

Not Applicable

Conditions

Functional Dyspepsia
Small Intestinal Bacterial Overgrowth
Chronic Abdominal Discomfort

Interventions

Rifaximin
Lactulose Breath Test
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R21DK078101-02	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Mar 2012Actual

Completion Date

Not provided

First Submitted Date

Aug 10, 2009

First Submission Date that Met QC Criteria

Aug 10, 2009

First Posted Date

Aug 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2012

Last Update Posted Date

Oct 24, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug	rifaximin 550 mg TID PO x 10 days	FD Participants	Xifaxan

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Henry C Lin, MD	New Mexico VA Healthcare System	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
General Clinical Research Center		Albuquerque	New Mexico	87131	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000078262	Rifaximin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

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Browse Branches

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