Status:

COMPLETED

Gulf War Digestive Health Study

Lead Sponsor:

US Department of Veterans Affairs

Conditions:

Irritable Bowel Syndrome

Small Intestinal Bacterial Overgrowth

Eligibility:

All Genders

35-72 years

Phase:

NA

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 ...

Detailed Description

Approximately 700,000 United States military personnel were deployed in the first Persian Gulf (PG) War. Several months after their return, up to 25% of Veterans had persistent symptoms which they sus...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

54 Patients enrolled

Trial Details

Trial ID

NCT00680836

Start Date

October 1 2007

End Date

December 1 2013

Last Update

August 29 2014

Active Locations (1)

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1

Division of Epidemiology

Salt Lake City, Utah, United States, 84132