Butyrate treatment for Gulf War Illness
Microbiome Targeted Oral Butyrate Therapy in Gulf War Multisymptom Illness
This study is testing if a butyrate treatment can help improve physical function and reduce symptoms in Veterans with Gulf War Illness.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 3 sites (Long Beach, California and 2 other locations) |
| Trial ID | NCT05367245 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a butyrate formulation, consisting of calcium and magnesium derivatives, in improving physical function and alleviating symptoms in Veterans suffering from Gulf War Illness (GWI). Participants will be randomly assigned to receive either the butyrate treatment or a placebo for 18 weeks, with assessments focusing on physical functioning, gastrointestinal health, chronic fatigue, systemic inflammation, and cognitive deficits. The study will utilize validated measures such as the Short Form Health Survey (VSF-36) to gauge changes in health status over the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are Gulf War era Veterans aged 40 to 70 who meet the CDC and Kansas criteria for GWI and have moderate to severe symptoms.
Not a fit: Patients with untreated severe mental health disorders, active substance abuse, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for Veterans suffering from Gulf War Illness by enhancing physical function and reducing debilitating symptoms.
How similar studies have performed: While the use of butyrate has shown promise in preclinical studies for gastrointestinal disturbances, this specific application in Gulf War Illness is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 . Exclusion Criteria: * Untreated schizophrenia, * Untreated bipolar disorder, * Untreated delusional disorders, * Untreated dementias of any type and * active alcoholism or drug abuse. * Medical conditions excluded include (i) organ failure, (ii) defined rheumatologic inflammatory disorders, and (iii) transplant. * Use of Butyrate in any form in the 3 months prior to study drug, medications that would impact gut motility, diarrhea, chronic pain, and immune function e.g., steroids, (Last 3 months) * immunosuppressive drugs or biologic response modifiers within 3 months of study entry will be used as exclusion criteria. * Pregnancy, or planned pregnancy in the next 6 months, * Body mass index more than 35 * Specific diets that may have enhanced or enriched fiber or butyrogenic formulations (FODMAP) * Medications that could potentially impact immune function in the past one month will be excluded (e.g., steroids, antibiotics, immunosuppressives; * Medications containing supplement calcium or magnesium butyrate should not be taken for at least 3 months before study entry. * Nutraceuticals that are formulated to impact gut microbiome or immune health) and use of drugs that affect GI motility and use of any antibiotic in the last 2 months. * Known allergy to butyrate supplements or their derivatives such as sodium salts or hydroxy derivatives of butyrate and/or inactive ingredients of active and placebo soft gelatin will also be excluded. * Current evidence of celiac disease or late-stage cirrhosis of the liver, Giardia antigen presence, Clostridium difficile toxin in stool, tissue transglutaminase antibody, recent change in gastrointestinal medications, use of drugs that affects gastrointestinal motility, and use of any antibiotic in the last two months also will be excluded.
Where this trial is running
Long Beach, California and 2 other locations
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States (Recruiting)
- Miami VA Healthcare System, Miami, FL — Miami, Florida, United States (Recruiting)
- VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Saurabh Chatterjee, PhD — VA Long Beach Healthcare System, Long Beach, CA
- Study coordinator: Saurabh Chatterjee, PhD
- Email: saurabhc@hs.uci.edu
- Phone: (562) 826-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.