Ca-Mg Butyrate in GWI
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-70
SponsorVA Office of Research and Development
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 groupsSponsors and collaborators
VA Office of Research and Development
Lead sponsor
Miami VA Healthcare System
Collaborator
VA Salt Lake City Health Care System
Collaborator
Source ClinicalTrials.gov