RECRUITING

Mechanisms of Gulf War Illness

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf. The pathophysiologic mechanisms of these chronic gastrointestinal symptoms are not well understood but cause significant morbidity in veterans. Our proposed studies will provide an innovative and novel treatment trial for chronic gastrointestinal symptoms in veterans with Gulf War Illness that were deployed into war zones. Given that there are currently no specific treatments for these disorders, and that current symptomatic approaches are far from ideal, proof of principle of our trial would be an extremely important advance as it would not only have a beneficial impact on the health of many thousands of our veterans, but also it would substantially reduce the many negative economic effects of this ailment on the VA Health Care System.

Official Title

Mechanisms of Gulf War Illness

Quick Facts

Study Start:2023-10-16
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05972291

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) that started during their deployment in the Persian Gulf
  2. 2. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating)
  3. 3. increased intestinal permeability on the lactulose/mannitol permeability test (ratio \>0.07)
  4. 4. able and willing to cooperate with the study
  1. 1. current participation in another research protocol or unable to give informed consent
  2. 2. women with a positive urine pregnancy test or breastfeeding
  3. 3. history of inflammatory bowel disease, lactose intolerance and/or celiac sprue
  4. 4. + hydrogen breath test for bacterial overgrowth
  5. 5. + anti-endomysial antibody titer
  6. 6. use of NSAIDs 2 weeks before or during the study
  7. 7. known allergy to glutamine or whey protein
  8. 8. abdominal surgery except for removal of gallbladder, uterus, or appendix \>6 months prior to entry into the study
  9. 9. Abnormal serum BUN and/or creatinine
  10. 10. Mannitol recovery out of the normal range of 5-25 U/g
  11. 11. history of kidney disease
  12. 12. allergies to monosodium glutamate
  13. 13. current use of anti-seizure medications

Contacts and Locations

Study Contact

George N Verne
CONTACT
(901) 523-8990
George.Verne@va.gov
QiQi Zhou, MD PhD
CONTACT
(901) 523-8990
qiqi.zhou@va.gov

Principal Investigator

QiQi Zhou, MD PhD
PRINCIPAL_INVESTIGATOR
Memphis VA Medical Center, Memphis, TN
George N Verne
PRINCIPAL_INVESTIGATOR
Memphis VA Medical Center, Memphis, TN

Study Locations (Sites)

Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104-2127
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • QiQi Zhou, MD PhD, PRINCIPAL_INVESTIGATOR, Memphis VA Medical Center, Memphis, TN
  • George N Verne, PRINCIPAL_INVESTIGATOR, Memphis VA Medical Center, Memphis, TN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • gastrointestinal
  • irritable bowel syndrome
  • glutamine

Additional Relevant MeSH Terms

  • Gulf War Illness
  • Irritable Bowel Syndrome
  • Gastrointestinal Symptoms