About this trial

The primary objective of this clinical trial is to determine if treatment with Butyrate formulation that consists of butyric acid as calcium and magnesium derivatives (Ca-Mg Butyrate) improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (VSF-36), with respect to physical functioning and symptoms. The secondary outcome will focus on the drug's role in (a) restoring gut microbiome and virome, (b) decreasing gastrointestinal disturbances (constipation, diarrhea, pain), (c) decreasing chronic fatigue, (d) decreasing systemic inflammation, and (e) a decrease in cognitive deficits.

Eligibility criteria

Qualifiers

Gulf war era veteran deployed 40 and 70 years old, in good health by medical history prior to 1990 meeting GWI case definition of CDC and Kansas criteria and

currently have no exclusionary diagnoses (self- reported) that could reasonably explain the symptoms of their fatiguing illness. The severity of illness is moderate to severe, scoring less than 30 of 100 on the physical domain of VSF36 .

Disqualifiers

Untreated schizophrenia,

Untreated bipolar disorder,

Untreated delusional disorders,

Untreated dementias of any type and

Trial design

Treatments tested in this trial

  • Cal-Mag Butyrate
  • Placebo

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

3
VA Long Beach Healthcare System, Long Beach, CA90822, Long BeachCalifornia, United States
Miami VA Healthcare System, Miami, FL33125, MiamiFlorida, United States
VA Salt Lake City Health Care System, Salt Lake City, UT84148-0001, Salt Lake CityUtah, United States

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

Miami VA Healthcare System

Collaborator

VA Salt Lake City Health Care System

Collaborator