VA Office of Research and Development
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.
Gulf War Illness
Chronic Fatigue
Neurocognitive Dysfunction
Cal-Mag Butyrate
Placebo
Phase 2
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 120 participants |
Masking : | Quadruple |
Masking Description : | Quadruple, participants, care provider, investigators and outcome assessor will not have access to blinding. Only research pharmacist to distribute the drug or placebo and study coordinator to keep a confidential and secure records, will have access to the blinding. |
Primary Purpose : | Treatment |
Official Title : | Microbiome Targeted Oral Butyrate Therapy in Gulf War Multisymptom Illness |
Actual Study Start Date : | January 15, 2024 |
Estimated Primary Completion Date : | January 10, 2025 |
Estimated Study Completion Date : | March 31, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Cal-Mag-Butyrate Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food. |
Drug: Cal-Mag Butyrate |
Placebo Comparator: Placebo for Cal-Mag-Butyrate Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food. |
Drug: Placebo |
Ages Eligible for Study: | 40 Years to 70 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Recruiting
Miami VA Healthcare System, Miami, FL
Miami, florida, United States, 33125
Not yet recruiting
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148