Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

The adverse impact of Gulf War Syndrome (GWS) on the health of veterans and on the resources of the VA Healthcare System underscores the need to resolve its underlying cause. In response, the investigators propose to investigate the central hypothesis that gut bacteria may be responsible for symptoms associated with GWS. The investigators will enroll a total of 120 patients with GWS and 90 healthy controls.

Study Overview

• Status: Unknown
• Conditions: Gulf War Syndrome
• Intervention / Treatment: Procedure: Lactulose Breath Test; Drug: Rifaximin; Drug: Placebo

Detailed Description

The investigator will assess the prevalence and role of abnormal gut microbial fermentation among Veterans with GWS and investigate the efficacy of diagnostic and treatment strategies directed at indigenous gut microbes in the management of GWS.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Natalie R Mills, BS; Phone Number: 2286 505-265-1711; Email: Natalie.Mills@va.gov
• Study Contact Backup: Name: Henry C Lin, MD; Phone Number: 4511 505-265-1711; Email: helin@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Recruiting
      • New Mexico VA Healthcare System
      • Contact: Natalie R Mills, BS; Phone Number: 2286 505-265-1711; Email: Natalie.Mills@va.gov
      • Contact: Henry C Lin, MD; Phone Number: 4511 505-265-1711; Email: helin@salud.unm.edu
      • Principal Investigator: Henry C Lin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Gulf War Veterans meeting the 1994 Centers for Disease Control and Prevention (CDC) criteria for the diagnosis of Chronic Fatigue Syndrome(CFS), i.e > six months of one or more symptoms from at least two of the following three clusters: general fatigue, mood and cognitive abnormalities, and musculoskeletal pain
• Must be under the care of a primary physician and have had a previous diagnosis of Gulf War-related illness or GWS and have medical records documenting investigations to rule out other causes of fatigue
• Minimum of the following laboratory screening tests: complete blood count with leukocyte differential, erythrocyte sedimentation rate, serum electrolytes, calcium, glucose, blood urea nitrogen, creatinine,urinalysis, and thyroid function tests
• Subjects must also have a GI consult first as part of routine care to confirm eligibility and availability
• Patients with Irritable Bowel Syndrome (IBS), fibromyalgia (FM), anxiety or depression will not be excluded, but will be identified for subgroup analysis
• Healthy controls will be screened with complete blood count (CBC) and comprehensive metabolic panel to confirm eligibility

Exclusion Criteria:

• History of peptic ulcer, inflammatory bowel disease, diabetes, cirrhosis, rheumatoid arthritis, lupus, narcotic dependence,celiac disease, tropical sprue, bowel resection(including gastric, small bowel or colon; but gallbladder surgery or appendectomy are NOT exclusion criteria)
• Patients with chronic illness (HIV, tuberculosis)
• Pregnant or breast-feeding, psychotic depression, bipolar disorder, schizophrenia, eating disorders
• Healthy subjects will be excluded if their questionnaire indicated abnormal symptom profile

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 60 GWS Rifaximin	Procedure: Lactulose Breath Test; Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).; Drug: Rifaximin; Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
Placebo Comparator: 60 GWS Placebo	Procedure: Lactulose Breath Test; Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).; Drug: Placebo; Placebo TID PO x 10 days
Experimental: Healthy Control; Patient is a healthy control and will not be on study intervention. Asked to perform Lactulose Breath Test to compare results with GWS patients.	Procedure: Lactulose Breath Test; Test will begin with a baseline breath sample followed by ingestion of 10g of lactulose (Xactdose, South Beloit, IL) in 100ml of water. Breath samples will be collected every 15 min for 180 min. Gas samples will be analyzed for hydrogen and methane using a gas chromatograph (Model SC, Quintron Instruments, Milwaukee, WI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test	every 15 minutes for 180 minutes
To determine the response to antibiotic treatment in Gulf War Syndrome patients.	Two weeks

Collaborators and Investigators

• Sponsor: Henry C. Lin, MD

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: August 10, 2009
• First Submitted That Met QC Criteria: August 10, 2009
• First Posted (Estimate): August 11, 2009

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 30, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Gulf War Syndrome; Small Intestinal Bacterial Overgrowth; Chronic Multisymptom Complex; Chronic Multisymptom Illness Complex
• Additional Relevant MeSH Terms: Occupational Diseases; Persian Gulf Syndrome; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin; Lactulose
• Other Study ID Numbers: HRRC 07-155