RecruitingNot ApplicableNCT06464952

Microbiome Modulation With Prebiotics in PTSD and Cirrhosis

Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation (RESIST-PTSD)


Sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Enrollment

30 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking prebiotic supplements (food that feeds healthy gut bacteria) can improve gut health and reduce PTSD symptoms in people who have both liver cirrhosis and PTSD. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with liver cirrhosis - You have a confirmed diagnosis of PTSD from a mental health provider - You are willing and able to take oral supplements and attend follow-up visits **You may NOT be eligible if...** - You have had a COVID-19 infection in the last 60 days - You have active liver failure or other serious complications of cirrhosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTResistant potato starch

Prebiotic

DIETARY_SUPPLEMENTPowdered cellulose

Active comparator


Locations(1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

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NCT06464952


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