Gulf War Digestive Health Study

NCT00680836 | Completed Results

• 1 other identifier: GWRA-014-05F
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Small Intestinal Bacterial Overgrowth

Keywords

Irritable Bowel Syndrome; Diarrhea; Gulf War; Veterans; Small intestinal bacterial overgrowth (SIBO)

Outcome Measures

Primary Outcomes (1)

• Global Improvement Scale

  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.

  Measured for seven days at the end of 2 weeks treatment and average score is calculated

Secondary Outcomes (5)

• Change in Stool Frequency (Number of Bowel Movements Per Day)

  2 weeks

• Change in Stool Consistency

  2 weeks

• Change in Bowel Urgency

  2 weeks

• Change in Abdominal Pain With Bowel Movement

  2 weeks

• Change in Bloating

  2 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

These patients have IBS and are receiving the rifaximin.

Drug: Rifaximin

Placebo group

PLACEBO COMPARATOR

These patients have IBS and are receiving the placebo.

Drug: Placebo

Interventions

Placebo DRUG

orally two times per day for 14 days

Also known as: Inactive pill

Placebo group

Rifaximin DRUG

550 mg orally two times per day for 14 days

Also known as: Xifaxan

Treatment Group

Eligibility Criteria

• Age: 35 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Division of Epidemiology

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Ashok Tuteja, M.D.
• Organization: George E. Wahlen V.A. Medical Center, Salt Lake City, UT

ashok.tuteja@va.gov

801-582-1565

Study Officials

• Ashok K Tuteja, MD MPH

  Division of Epidemiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2013
• Last Updated: August 29, 2014
• Results First Posted: August 29, 2014

Record last verified: 2014-08

Locations

US (1)