Richmond, VANCT06464952Now EnrollingIRB Ready

Cirrhosis Clinical Trial in Richmond, VA

Access cutting-edge cirrhosis treatment through this clinical trial at a research site in Richmond. Study-provided care at no cost to qualified participants.

Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center

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Expert Care in Richmond

Access cirrhosis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cirrhosis treatment provided free

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Check if you qualify for this cirrhosis clinical trial in Richmond, VA

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Why Participate?

  • No-Cost Study Care

  • Local to Richmond

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Richmond site if eligible
  4. 4Begin participation

About This Cirrhosis Study in Richmond

Despite medical advancements, PTSD remains a major issue in Veterans1. Current treatment strategies have relatively poor adherence. In patients with PTSD and cirrhosis, there is greater cognitive impairment as well as changes in gut microbiome structure and function2,3. In addition, when there is concomitant cirrhosis, medication-related treatment options become even narrower from a safety and tolerability perspective and cognitive issues pertaining to cirrhosis could impact participation3. Changes in gut microbiome in Veterans with cirrhosis and PTSD compared to those with cirrhosis without PTSD is characterized by a greater relative expression of pathobionts and reduction in stool microbiome diversity with reduction in bacteria that produce beneficial short chain fatty acids (SCFA)2. Modulation of the gut microbiome in patients with cirrhosis and PTSD may be an important therapeutic target. In prior studies with cirrhosis alone, microbial modulation using diet, antibiotics such as rifaximin, probiotics, and fecal microbiota transplant have improved gut microbial diversity and clinical outcomes in some cases4,5. In patients with cirrhosis without PTSD and in patients with PTSD without cirrhosis there is emerging evidence regarding prebiotics and other forms of gut microbial modulation. Prebiotics are such an example6. Prebiotics are natural fibers derived from carbohydrates and can be beneficial to gut microbiota (good bacteria in the gut)6. Resistant starches (RS) are dietary fiber prebiotics found naturally in many foods including potatoes, plantains, and legumes6,7. In addition to being highly accessible, RS have been shown to be well tolerated with few adverse reactions. While no studies of RS exist in PTSD + cirrhosis patients, a meta-analysis of RS in IBD has shown RS to be an effective treatment in both animal and clinical studies where improvements in clinical remission and reduced mucosal damage were found7. However, there is insufficient data regarding patients with PTSD and cirrhosis regarding gut microbial structure and function modulation with dietary supplements such as resistant starches. These starches can improve SCFA production in elderly subjects, which could in turn affect the gut-brain axis favorably8.

Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Who Can Participate

Inclusion Criteria

Age \>18 years
Ability to provide informed written consent
Cirrhosis diagnosis
Willing to comply with all study procedures and be available for the duration of the study.
Ability to take oral medication.
Willing to provide study-related samples
Meeting the PCL-5 definition of PTSD and have a chart diagnosis of PTSD made by a mental health provider

Exclusion Criteria

Known SARS-CoV-2 infection in the last 60 days using medical records
Subjects identified as, or appearing to, lack consent capacity
Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
Active illicit drug use (marijuana is allowed)
Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
Individuals who are pregnant, lactating or planning on becoming pregnant during the study
Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac disease
Unstable psychiatric illness (psychosis)
Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days
Systemic antibiotics in the last 30 days
Fecal microbiota transplant in the last 30 days
Active dysphagia
Allergies to any of the ingredients in assigned products
Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days.
On treatment for hepatic encephalopathy.
Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Richmond?

Yes, this clinical trial (NCT06464952) has an active research site in Richmond, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cirrhosis Treatment Options in Richmond, VA

If you're searching for cirrhosis treatment options in Richmond, VA, this clinical trial (NCT06464952) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Richmond research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cirrhosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cirrhosis clinical trials near you to find additional studies recruiting in your area.

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