Ca-Mg Butyrate in GWI

NCT05367245 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: SPLD-006-21SI01CX002372
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Gulf War Illness; Chronic Fatigue; Neurocognitive Dysfunction

Keywords

SCFA; Gulf War Illness; GWI; Microbiome; Butyric acid; Butyrate

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline at 3, 6, 9, 12, 18 and 20 weeks

Secondary Outcomes (1)

• California Verbal Learning Test (CVLT-II)

  Change from Baseline at 9, 18 and 20 weeks

Study Arms (2)

Cal-Mag-Butyrate

EXPERIMENTAL

Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.

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.

Drug: Placebo

Interventions

Cal-Mag Butyrate DRUG

Supplements

Also known as: Bodybio Calcium Magnesium Butyrate

Cal-Mag-Butyrate

Placebo DRUG

Only Cal-Mag but no Butyric acid

Also known as: Placebo Cal-Mag Butyrate

Placebo for Cal-Mag-Butyrate

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Miami VA Healthcare System: collaborator
• VA Salt Lake City Health Care System: collaborator

Study Sites (3)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

RECRUITING

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

RECRUITING

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

Salt Lake City, Utah, 84148-0001, United States

RECRUITING

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Saurabh Chatterjee, PhD

  VA Long Beach Healthcare System, Long Beach, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saurabh Chatterjee, PhD

CONTACT

(562) 826-8000; saurabhc@hs.uci.edu

Jonathan Skupsky

CONTACT

(562) 826-8000; Jonathan.Skupsky@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: -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

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: January 15, 2024
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)