Phase II Study of Oral Calcium-Magnesium Butyrate Therapy for Physical and Cognitive Symptoms in Gulf War Illness Veterans Aged 40 to 70

What this Trial Is About

Researchers are studying whether a special butyrate supplement called Ca-Mg Butyrate can improve physical function in men and women Veterans suffering from Gulf War Illness GWI, a chronic condition with multiple symptoms that affects about one third of deployed military personnel from the Desert Shield and Desert Storm era. The trial aims to measure changes in physical functioning and symptoms using the Veterans Short Form 36-item Health Survey VSF-36. It also looks at effects on gut microbiome health, gastrointestinal symptoms, fatigue, inflammation, and cognitive problems. This is a randomized, double-blind, placebo-controlled Phase II trial comparing two groups. One group takes microencapsulated Ca-Mg Butyrate capsules 600 mg twice daily for 18 weeks, while the other takes matching placebo capsules on the same schedule. After 18 weeks of treatment, there will be virtual follow-up visits at 20 weeks. The study monitors changes in physical and mental functioning using VSF-36 and the California Verbal Learning Test CVLT-II, along with assessments of gut microbiome, intestinal permeability, inflammation markers, and GWI symptoms like IBS, chronic pain, fatigue, sleep issues, and cognitive difficulties. Participants will be evaluated at multiple time points during and after treatment to track changes from baseline. Assessments include questionnaires, cognitive tests, and biological samples to analyze microbiome and inflammation. Safety and symptom monitoring continue through 20 weeks. The full participation duration is about 20 weeks, with visits including in-person and virtual assessments. The study is designed to understand how Ca-Mg Butyrate affects the complex symptoms of Gulf War Illness over the treatment period and shortly after.

Ca-Mg Butyrate in GWI