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Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

Primary Purpose

Gulf War Syndrome

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lactulose Breath Test
Rifaximin
Placebo
Sponsored by
Henry C. Lin, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gulf War Syndrome focused on measuring Chronic Multisymptom Complex, Small Intestinal Bacterial Overgrowth, Gulf War Syndrome, Chronic Multisymptom Illness Complex

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New Mexico VA Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

60 GWS Rifaximin

60 GWS Placebo

Healthy Control

Arm Description

Patient is a healthy control and will not be on study intervention. Asked to perform Lactulose Breath Test to compare results with GWS patients.

Outcomes

Primary Outcome Measures

To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test
To determine the response to antibiotic treatment in Gulf War Syndrome patients.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2009
Last Updated
April 30, 2013
Sponsor
Henry C. Lin, MD
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1. Study Identification

Unique Protocol Identification Number
NCT00956150
Brief Title
Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
Official Title
Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henry C. Lin, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gulf War Syndrome
Keywords
Chronic Multisymptom Complex, Small Intestinal Bacterial Overgrowth, Gulf War Syndrome, Chronic Multisymptom Illness Complex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
60 GWS Rifaximin
Arm Type
Active Comparator
Arm Title
60 GWS Placebo
Arm Type
Placebo Comparator
Arm Title
Healthy Control
Arm Type
Experimental
Arm Description
Patient is a healthy control and will not be on study intervention. Asked to perform Lactulose Breath Test to compare results with GWS patients.
Intervention Type
Procedure
Intervention Name(s)
Lactulose Breath Test
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Rifaximin 600 mg three times a day by mouth (TID PO) x 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo TID PO x 10 days
Primary Outcome Measure Information:
Title
To compare the pattern of bacterial gas excretion in breath among Veterans with Gulf War Syndrome vs. Controls using Lactulose Breath Test
Time Frame
every 15 minutes for 180 minutes
Title
To determine the response to antibiotic treatment in Gulf War Syndrome patients.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie R Mills, BS
Phone
505-265-1711
Ext
2286
Email
Natalie.Mills@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Henry C Lin, MD
Phone
505-265-1711
Ext
4511
Email
helin@salud.unm.edu
Facility Information:
Facility Name
New Mexico VA Healthcare System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie R Mills, BS
Phone
505-265-1711
Ext
2286
Email
Natalie.Mills@va.gov
First Name & Middle Initial & Last Name & Degree
Henry C Lin, MD
Phone
505-265-1711
Ext
4511
Email
helin@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Henry C Lin, MD

12. IPD Sharing Statement

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Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

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