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The overall objective of the study is to determine whether probiotic VSL#3 will improve 1) intestinal symptoms of Irritable Bowel Syndrome and 2) non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War illness. We screened our first participant in September 2013. Overall we have screened 47 and enrolled 26 Gulf War Veterans so far. Our efforts are ongoing to recruit more Gulf War veterans. The first set of stool samples have been sent to Lawrence Berkeley Laboratory microbiota analysis.

The overall objective of the study is to determine whether probiotic VSL#3 will improve 1) intestinal symptoms of Irritable Bowel Syndrome and 2) non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War illness. The project was approved by Human Research Protection Office, Department of Defense in August 2013. We received the drug shipment from the manufacturer of VSL#3 in September 2013. We are in contact with the Lawrence Berkeley Laboratories to arrange for shipment of stool samples and microflora analysis. We screened our first participant in September 2013.

The overall objective of the study was to determine whether Bifidobacterium infantis 35624 (Align ) will improve symptoms of GW illness. We have not started the study as yet. We were unable to get IND (Investigational New Drug) number for the probiotic, Bifidobacterium infantis 35624 (Align ). We requested the Department of Defense to allow us to use another commonly used probiotic, VSL#3. The Department of Defense contract has been modified to include this change. The Confidentiality Disclosure Agreement between VSL Pharmaceuticals and the Department of Veterans Affairs has been agreed. We have received IND from the Food and Drug Administration (FDA) for VSL#3. Our application is with University of Utah Institutional Review Board at the final stages of approval. This application will be sent to Department of Defense for their approval before starting the study.

The overall objective of the study was to determine whether Bifidobacterium infantis 35624 (Align ) will improve symptoms of GW illness. We have not started the study as yet. This is due to inability to get IND (Investigational New Drug) number for the probiotic, Bifidobacterium infantis 35624 (Align ). The manufactures of Bifidobacterium infantis 35624 (Align ), Procter & Gamble could not provide the necessary manufacturing information to Food and Drug Administration (FDA). We requested the Department of Defense to allow us to use another commonly used probiotic, VSL#3. The Department of Defense contract has been modified to include this change. The Confidentiality Disclosure Agreement between VSL Pharmaceuticals and the Department of Veterans Affairs has been agreed.

The goal of this research program is to develop safe and efficacious osseointegrated implants that can be implanted into our warrior amputees who have limited residual limb length, extensive heterotopic ossification or difficulty with socket suspension type systems, leaving them with a non-functional limb or limbs. The new technology is to assure skin attachment at the percutaneous site, where the implant exits the skin, to prevent infection. Strategies explored in this research are the use of porous coating biomaterials that will allow immediate skeletal and subdermal skin attachment to facilitate a single stage operation for eventual rapid patient rehabilitation. The safe and efficacious introduction of the osseointegrated implant technology for our deserving warriors is the overall goal of our program.

This is the first year annual report of this four year research program to develop osseointegrated implants for amputees. This research will provide the basic foundations for the safe and efficacious design of implants for above the knee active amputees. These implants will allow for direct loading of the bone and have a safety release mechanism to prevent abutment and bone- implant interface failure and bone fracture. The first year of research focused on determining morphometric variations in the internal structure of the human femur as a function of gender age and ethnic background. Anthropometric studies were conducted along the length of the femur to develop sizing and design criteria. It has been a productive and challenging first year. The challenge of obtaining human cadaver specimens delayed our timeline but we will complete the task within the first quarter of the second year. We believe we have established the imaging principles for developing customized osseointegrated implants., The original document contains color images.