RECRUITING

Ca-Mg Butyrate in GWI

Conditions

Gulf War Illness Chronic Fatigue Neurocognitive Dysfunction SCFA GWI Microbiome Butyric acid Butyrate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Microbiome Targeted Oral Butyrate Therapy in Gulf War Multisymptom Illness

Quick Facts

Study Start:2024-01-15

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05367245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 .	* 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.

Inclusion Criteria

Exclusion 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 .

* 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.

Contacts and Locations

Study Contact

Saurabh Chatterjee, PhD

CONTACT

(919)599-2278

saurabhc@hs.uci.edu

Jonathan Skupsky

CONTACT

(562) 826-8000

Jonathan.Skupsky@va.gov

Principal Investigator

Saurabh Chatterjee, PhD

PRINCIPAL_INVESTIGATOR

VA Long Beach Healthcare System, Long Beach, CA

Study Locations (Sites)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822

United States

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125

United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Saurabh Chatterjee, PhD, PRINCIPAL_INVESTIGATOR, VA Long Beach Healthcare System, Long Beach, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-15

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-01-15

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

SCFA
Gulf War Illness
GWI
Microbiome
Butyric acid
Butyrate

Additional Relevant MeSH Terms

Gulf War Illness
Chronic Fatigue
Neurocognitive Dysfunction