Gulf War Digestive Health Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00680836
First received: May 16, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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 Intervention
Irritable Bowel Syndrome
Small Intestinal Bacterial Overgrowth
Drug: Placebo
Drug: Rifaximin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Global Improvement Scale [ Time Frame: Measured for seven days at the end of 2 weeks treatment and average score is calculated ] [ Designated as safety issue: No ]
    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:
  • Change in Stool Frequency (Number of Bowel Movements Per Day) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Stool Consistency [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Bowel Urgency [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Abdominal Pain With Bowel Movement [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Bloating [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 54
Study Start Date: October 2007
Study Completion Date: December 2013
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   35 Years to 72 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680836

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680836     History of Changes
Other Study ID Numbers: GWRA-014-05F
Study First Received: May 16, 2008
Results First Received: December 9, 2013
Last Updated: August 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Irritable Bowel Syndrome
Diarrhea
Gulf War
Veterans
Small intestinal bacterial overgrowth (SIBO)

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014