| NCT ID | NCT05367245 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Gulf War Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2026-10-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-01-15 with a primary completion date of 2026-10-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Saurabh Chatterjee, PhD
PRINCIPAL INVESTIGATOR
VA Long Beach Healthcare System, Long Beach, CA
Frequently Asked Questions
Who can join the NCT05367245 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Gulf War Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05367245 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05367245 currently recruiting?
Yes, NCT05367245 is actively recruiting participants. Contact the research team at saurabhc@hs.uci.edu for enrollment information.
Where is the NCT05367245 trial being conducted?
This trial is being conducted at Long Beach, United States, Miami, United States, Salt Lake City, United States.
Who is sponsoring the NCT05367245 clinical trial?
NCT05367245 is sponsored by VA Office of Research and Development. The principal investigator is Saurabh Chatterjee, PhD at VA Long Beach Healthcare System, Long Beach, CA. The trial plans to enroll 120 participants.