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Gulf War Digestive Health Study
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, December 2008
First Received: May 16, 2008   Last Updated: December 29, 2008   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00680836
  Purpose

The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether 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
Drug: Placebo
Drug: Rifaximin

MedlinePlus related topics: Diarrhea
Drug Information available for: Rifaximin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Improvement in IBS Global Improvement Scale. [ Time Frame: once a month for the 6 months following completion of medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Symptom Severity [ Time Frame: 6 months after medication regimine is completed ] [ Designated as safety issue: No ]
  • Change in IBS-QOL Questionnaire [ Time Frame: 1 week after starting the medication, 2 weeks after starting the medication, 1 month after finishing medication, 6 months after finishing medication ] [ Designated as safety issue: No ]
  • Change in LBT [ Time Frame: 6 months after completion of medication ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
These patients do not have IBS. They may be deployed or non-deployed veterans.
2: Active Comparator
These patients have IBS and are receiving the rifaximin.
Drug: Rifaximin
550 mg orally two times per day for 14 days
3: Placebo Comparator
These patients have IBS and are receiving the placebo.
Drug: Placebo
orally two times per day for 14 days

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 suspected were related to their military service in the Gulf. Among the most frequent were gastrointestinal symptoms such as loose stools, excessive gas and abdominal pain. These symptoms are typical of diarrhea-predominant irritable bowel syndrome (IBS).

The cause of IBS is not known; speculated mechanisms include altered GI motility, bacterial overgrowth, visceral hypersensitivity and psychological stress. Another proposed mechanism relates to the fact that up to one third of patients with IBS describe the onset of their symptoms following acute gastroenteritis. This is called post-infective IBS (PI-IBS). How acute gastroenteritis leads to persistent GI symptoms of IBS is not known. A limited amount of data suggests that patients with IBS may have an imbalance in their gastrointestinal microflora. Several studies indicate that small bowel bacterial overgrowth is more common in individuals with IBS. Symptoms of SBBO are similar to diarrhea-predominant IBS and include chronic diarrhea, bloating and abdominal pain. More than 50 percent of military personnel developed acute gastroenteritis while on duty in the Gulf. Most of them who reported symptoms of IBS had an acute onset which occurred in association with an episode of acute gastroenteritis during their tour of duty. Other travelers are known to be colonized by new micro-organisms during travel to foreign countries. This acquisition is thought to be related to a change in diet. The natural history of this change in bowel flora, in part, depends on host factors and can persist for months after travel abroad. It seems likely, that PG veterans with persistent diarrhea and a negative work-up for known GI diseases have PI-IBS. No study in the past has evaluated the role of SBBO in causing chronic GI symptoms in PG Veterans. Furthermore, soldiers involved in combat are exposed to a highly stressful environment, perhaps making them more susceptible to persistent symptoms. We hypothesize that PG veterans with chronic GI symptoms have symptoms of diarrhea predominant IBS and this is caused by SBBO due to a change in microflora during deployment in the Persian Gulf and that it is predisposed to by the stress of combat. Intestinal microflora, once altered, is known to be relatively stable; once mucosal damage occurs it may become permanent.

Objectives Objective # 1: Estimate the burden of disease due to chronic gastrointestinal illness in PG veterans.

Hypothesis:

i. The prevalence of GI symptoms is high in PG veterans. ii. The prevalence of IBS is higher in veterans who report acute gastroenteritis during the period of deployment.

iii. PG Veterans with IBS have a lower IBS related QOL

Objective # 2: Evaluate whether SBBO is associated with chronic diarrhea in PG veterans.

Hypothesis i. SBBO is more common in PG veterans than non deployed veterans. ii. SBBO is more common in PG veterans with diarrhea-predominant IBS vs. those without.

Objective: # 3: Determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG Veterans.

Hypothesis:

i. Treatment with rifaximin, a non-absorbable antibiotic, will improve symptoms and QOL in Veterans with SBBO.

  Eligibility

Ages Eligible for Study:   35 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680836

Contacts
Contact: Rebecca A Campo, PhD MS (801) 582-1565 ext 1993 rebecca.campo@va.gov
Contact: Diana Trujillo (801) 582-1565 ext 4840 diana.trujillo@va.gov

Locations
United States, Utah
Division of Epidemiology Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Rebecca A Campo, PhD MS     801-582-1565 ext 1993     rebecca.campo@va.gov    
Principal Investigator: Ashok K Tuteja, MD MPH            
Sponsors and Collaborators
Investigators
Principal Investigator: Ashok K Tuteja, MD MPH Division of Epidemiology
  More Information

Publications:
[No authors listed] Self-reported illness and health status among Gulf War veterans. A population-based study. The Iowa Persian Gulf Study Group. JAMA. 1997 Jan 15;277(3):238-45.
Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8.
Sostek MB, Jackson S, Linevsky JK, Schimmel EM, Fincke BG. High prevalence of chronic gastrointestinal symptoms in a National Guard Unit of Persian Gulf veterans. Am J Gastroenterol. 1996 Dec;91(12):2494-7.
[No authors listed] Unexplained illnesses among Desert Storm veterans. A search for causes, treatment, and cooperation. Persian Gulf Veterans Coordinating Board. Arch Intern Med. 1995 Feb 13;155(3):262-8.
Orskov F, Sack RB, Orskov I, Froelich JL. Changing fecal Escherichia coli flora during travel. Eur J Clin Microbiol. 1984 Aug;3(4):306-9.
Hyams KC, Bourgeois AL, Merrell BR, Rozmajzl P, Escamilla J, Thornton SA, Wasserman GM, Burke A, Echeverria P, Green KY, et al. Diarrheal disease during Operation Desert Shield. N Engl J Med. 1991 Nov 14;325(20):1423-8.
Camilleri M. Mechanisms in IBS: something old, something new, something borrowed... Neurogastroenterol Motil. 2005 Jun;17(3):311-6. No abstract available.
Singh VV, Toskes PP. Small Bowel Bacterial Overgrowth: Presentation, Diagnosis, and Treatment. Curr Treat Options Gastroenterol. 2004 Feb;7(1):19-28.
Spiller RC. Postinfectious irritable bowel syndrome. Gastroenterology. 2003 May;124(6):1662-71. Review.
Pimentel M, Chow EJ, Lin HC. Normalization of lactulose breath testing correlates with symptom improvement in irritable bowel syndrome. a double-blind, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):412-9.
Pimentel M, Soffer EE, Chow EJ, Kong Y, Lin HC. Lower frequency of MMC is found in IBS subjects with abnormal lactulose breath test, suggesting bacterial overgrowth. Dig Dis Sci. 2002 Dec;47(12):2639-43.
Pimentel M, Chow EJ, Lin HC. Eradication of small intestinal bacterial overgrowth reduces symptoms of irritable bowel syndrome. Am J Gastroenterol. 2000 Dec;95(12):3503-6.

Responsible Party: Department of Veterans Affairs ( Tuteja, Ashok - Principal Investigator )
Study ID Numbers: GWRA-014-05F, IRB#16469
Study First Received: May 16, 2008
Last Updated: December 29, 2008
ClinicalTrials.gov Identifier: NCT00680836     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Irritable Bowel Syndrome
Diarrhea

Study placed in the following topic categories:
Digestive System Diseases
Diarrhea
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome
Rifaximin
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:
Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome
Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on May 07, 2009