Gulf War IllnessPhase 2ButyrateNCT05367245
Ca-Mg Butyrate in Gulf War Illness
A Phase 2 study testing Cal-Mag Butyrate in people with Gulf War Illness and Chronic Fatigue, run by VA Office of Research and Development at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Gulf War Illness, Chronic Fatigue, Neurocognitive Dysfunction
- What is being tested?
- Cal-Mag Butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jan 2024to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gulf war era veteran deployed 40 and 70 years old, in good health by medical history prior to 1990 meeting GWI case definition of Centers for Disease Control and Prevention (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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Saurabh Chatterjee, PhD, (562) 826-8000, saurabhc@hs.uci.edu
Saurabh Chatterjee, PhD
- Recruiting
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Ana Palacio, MD, 305-575-7000 ext. 1 4204, nancy.klimas@va.gov
Devra Cohen, MPH, 3055757648, Devra.cohen@va.gov
- Recruiting
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
Ashok Tuteja, MD, 801-582-1565, ashok.tuteja@va.gov
About this study
Official title: Microbiome Targeted Oral Butyrate Therapy in Gulf War Multisymptom Illness
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.
Read the detailed description
Nearly one third of 700,000 military personnel deployed during Desert Shield and Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti War Theater are suffering from Gulf War Illness (GWI), an unexplained chronic illness characterized by multiple symptoms. The illness has taken a heavy toll on deployed Veterans' overall quality of life. Recent research has revealed the host gut microbiome's role in gastrointestinal disturbance, systemic inflammation, and neurotrophic abnormalities in Gulf War Illness mouse models. Also, short-chain fatty acids such as butyrate restored a healthy microbiome and improved gut microbial metabolism apart from attenuating GWI symptom persistence in preclinical studies. Butyrate, a nutraceutical endogenously produced in the host gut following bacterial fermentation, has shown promise in gastrointestinal disturbances such as irritable bowel syndrome (IBS) and Inflammatory bowel disease (IBD).
This is a randomized, two-group, double-blind, placebo-controlled, Phase II clinical trial. The treatment group will receive microencapsulated butyrate capsules (600 mg twice a day for 18 weeks). The placebo group will receive a matching placebo formulation twice a day for 18 weeks. However, after two weeks of the treatment (20 weeks) there will be a follow up virtual visits. The primary outcome measure for this clinical trial is a change from baseline of VSF-36 and CVLT III test scores with respect to physical and mental functioning and symptoms. The secondary outcome measures include changes from baseline of host-microbiome signature, intestinal permeability assessment, peripheral pro-inflammatory biomarkers, and GWI-associated symptoms IBS, chronic pain, fatigue, sleep issues, and cognitive impairment.
- Being tested
- Cal-Mag Butyrate, Placebo
- Keywords
- SCFA, Gulf War Illness, GWI, Microbiome, Butyric acid, Butyrate
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cal-Mag ButyrateDrug
Also called Bodybio Calcium Magnesium Butyrate
Supplements
PlaceboDrug
Also called Placebo Cal-Mag Butyrate
Only Cal-Mag but no Butyric acid
| Study group | Role | What they receive |
|---|---|---|
| Cal-Mag-Butyrate | Experimental | Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food. Receives: Drug: Cal-Mag Butyrate |
| Placebo for Cal-Mag-Butyrate | Placebo comparator | Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans Short Form 36-Item Health Survey Physical Component Summary
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. Qualify of life will be determined per Short Form-36 for Veterans' quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.
Measured: Change from Baseline at 3, 6, 9, 12, 18 and 20 weeks
Secondary outcomes (1)
California Verbal Learning Test (CVLT-II)
CVLT-II asks questions about cognitive symptoms related to recall and memory. The CVLT-II is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1-Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile. Scale ranges from 0 to 80 with 80 being the best.
Measured: Change from Baseline at 9, 18 and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start15 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- -Drug: Ca-Mg-Butyrate Take oral Capsule as directed (600 mg, two times a day for 18 weeks; 2x600 mg/day for 18 weeks) with food or without food. Other name: Calcium-Magnesium Butyrate, BodyBio Cal-Mag Butyrate -Drug: Placebo Take oral Capsule as directed (600 mg, two times a day for 18 weeks; 2x600 mg/day for 18 weeks) with food or without food. Other Name: Sugar pill, inactive substance
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Miami VA Healthcare System, VA Salt Lake City Health Care System
- Responsible party
- Sponsor
- Investigators
- Saurabh Chatterjee, PhD, Principal investigator, VA Long Beach Healthcare System, Long Beach, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367245
- Sponsor's protocol ID
- SPLD-006-21S
- Other IDs
- 5I01CX002372-03, I01CX002372
- Acronym
- Butyrate
- Status last verified
- Oct 2026
- First submitted
- 5 May 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No