Butyrate treatment for Gulf War Illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Modafinil for Debilitating Fatigue in Quiescent IBD

  A study will test whether modafinil can help adults with Crohn’s disease or ulcerative colitis who feel very fatigued even when their IBD is quiet.

  Recruiting at 2 sites Phase 2/3 Radboud University Medical Center · Arnhem, Gelderland and 1 other locations · NCT07582458

• Cognitive rehabilitation for ME/CFS brain fog

  Researchers are testing two cognitive rehabilitation approaches to see which helps adults with ME/CFS and brain fog better manage thinking and daily tasks.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT07523113

• Using machine learning to guide rTMS for Gulf War Illness–related headaches and body pain

  This trial will try using a machine learning model on resting brain scans to predict which active rTMS treatment will best reduce headaches and body pain in veterans with Gulf War Illness.

  Recruiting Veterans Medical Research Foundation · San Diego, California · NCT07325513

• Improving attention in military personnel with mild traumatic brain injury using brain stimulation and cognitive training

  This study is testing a new way to help Active Duty Service Members and Veterans with mild traumatic brain injury improve their attention by combining brain stimulation with cognitive training.

  Recruiting at 2 sites United States Naval Medical Center, San Diego · San Diego, California and 1 other locations · NCT06413173

• Using memantine to protect memory and cognition during craniospinal irradiation

  This study is testing if the drug memantine can help protect memory and thinking skills in patients getting radiation treatment for brain tumors.

  Recruiting Phase 3 Tata Memorial Centre · Mumbai, Maharashtra · NCT06275035

• Digital therapeutic program combining dance and music for chronic neurological disorders

  This study is testing a new dance and music program to see if it can help people with Multiple Sclerosis and early signs of cognitive decline feel better and improve their daily life.

  Recruiting at 3 sites Fondazione Don Carlo Gnocchi ETS · Brescia and 2 other locations · NCT06112639

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.