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Gulf War Digestive Health Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00680836
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth (SBBO) is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG veterans.

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth Drug: Placebo Drug: Rifaximin

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans
Study Start Date : October 2007
Primary Completion Date : October 2008
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Treatment Group
These patients have IBS and are receiving the rifaximin.
Drug: Rifaximin
550 mg orally two times per day for 14 days
Other Name: Xifaxan
Placebo Comparator: Placebo group
These patients have IBS and are receiving the placebo.
Drug: Placebo
orally two times per day for 14 days
Other Name: Inactive pill


Outcome Measures

Primary Outcome Measures :
  1. Global Improvement Scale [ Time Frame: Measured for seven days at the end of 2 weeks treatment and average score is calculated ]
    Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.


Secondary Outcome Measures :
  1. Change in Stool Frequency (Number of Bowel Movements Per Day) [ Time Frame: 2 weeks ]
    Change in stool frequency (number of bowel movements per day) compared from baseline to post treatment is measured. Number of bowel movements per day before treatment is subtracted from the number of bowel movements per day after treatment. The change in frequency has been reported in the outcomes table.

  2. Change in Stool Consistency [ Time Frame: 2 weeks ]
    Change in Stool consistency from baseline to post treatment is measured. Bristol stool scale is used for this purpose. The scale ranges from a value of 1- 7; 1 being very hard stool to 7 being liquid stools. The change is measured for 1 week post-treatment and the average consistency is used for the purpose of measuring change from baseline.

  3. Change in Bowel Urgency [ Time Frame: 2 weeks ]
    Urgency in a bowel movements compared from baseline to post treatment was measured. Participants were asked to note if they had urgency at bowel movements (meaning if they had to rush to the restroom). They marked either 'yes' or 'no'. The percentage of the time they said yes was calculated for 7 days. The difference between baseline and post treatment urgency was calculated.

  4. Change in Abdominal Pain With Bowel Movement [ Time Frame: 2 weeks ]
    Severity of abdominal pain on a scale of 0 to 4 was measured; 0 meaning no pain to 4 meaning severe pain. Change in abdominal pain from baseline to post treatment was calculated.

  5. Change in Bloating [ Time Frame: 2 weeks ]
    Bloating is measured on a scale from 0 to 4; 0 = no bloating to 4 = severe bloating. Change in bloating is calculated from baseline to post treatment.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 32-75 years
  • Rome III criteria for diarrhea-predominant IBS
  • Symptom onset after an apparent episode of acute gastroenteritis
  • Symptoms of > 3 months duration
  • Normal endoscopic appearance of the colonic mucosa
  • Negative markers for celiac disease and inflammatory bowel disease.
  • Normal thyroid function and serum calcium levels.
  • Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)

Exclusion Criteria:

  • Clinically significant cardiac, pulmonary, hepatic or renal dysfunction
  • History of/or presence of systemic malignancy
  • Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis)
  • Current effects of drug or alcohol abuse
  • Investigator perception of patients inability to comply with study protocol
  • Unstable psychiatric disease
  • Recent change in gastrointestinal medications
  • Subjects with a positive pregnancy test
  • Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680836


Locations
United States, Utah
Division of Epidemiology
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Ashok K Tuteja, MD MPH Division of Epidemiology
More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00680836     History of Changes
Other Study ID Numbers: GWRA-014-05F
First Posted: May 20, 2008    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014
Last Verified: August 2014

Keywords provided by VA Office of Research and Development:
Irritable Bowel Syndrome
Diarrhea
Gulf War
Veterans
Small intestinal bacterial overgrowth (SIBO)

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action