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Gulf War Illness Inflammation Reduction Trial

Principal Investigator: BACH, RONALD
Institution Receiving Award: CENTER FOR VETERANS RESEARCH AND EDUCATION FOUNDATION
Program: GWIRP
Proposal Number: GW130025
Award Number: W81XWH-14-1-0477
Funding Mechanism: Clinical Trial Award
Partnering Awards:
Award Amount: $1,044,682.00
Period of Performance: 9/29/2014 - 9/28/2023


PUBLIC ABSTRACT

The goal of this clinical trial is to determine if reducing inflammation is an effective treatment for Gulf War Illness (GWI). In our pilot study blood samples from Gulf War veterans with and without GWI were compared. There was strong evidence of chronic inflammation in veterans with GWI. Thus, chronic inflammation was identified as a potential target for treatment.

Only veterans with GWI will be enrolled in this study. An established anti-inflammatory drug known as prednisone will be the medication. Prednisone is widely used for the treatment of certain chronic inflammatory diseases. A new form of the drug known as delayed-release prednisone will be used in this study. It is designed to release the medication into the blood stream at ~2:00 a.m., when prednisone is most effective at reducing inflammation.

The dose of the drug and the length of the treatment were chosen to maximize the benefits of the treatment while minimizing the risks involved in taking the drug. Half the volunteers will take a pill containing the drug (treatment group) and half will take a pill that contains no medication (control group). The two pills will appear to be identical. Tests that measure quality of life, GWI symptoms, and inflammation will be performed three times during the study: at the beginning of the treatment period, at the end of the 8-week treatment period, and 8 weeks following the end of treatment. The trial will be completed in 4 years.

This clinical trial presents the exciting opportunity to determine if treating inflammation in veterans with GWI reduces their symptoms and improves their quality of life. If the results of the trial are positive, then a new point of view regarding the diagnosis and treatment of GWI would be established.

Using biomarkers of inflammation may improve diagnosis. Focusing on treatments designed to reduce inflammation and minimize toxicity could lead to additional improvements in the care of veterans with GWI. The impact of these changes on the health and well-being of veterans with GWI would be significant.