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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
30
Prebiotic
Active comparator
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
RECRUITINGGut microbiome Alpha Diversity between groups
Shannon diversity at end of interventions between both groups
Time frame: 8 weeks
Gut microbiome Alpha Diversity within groups at study end
Shannon diversity at end of interventions within each group
Time frame: 8 weeks
Gut microbiome Alpha Diversity within groups at mid-study
Shannon diversity at mid-study within each group
Time frame: 4 weeks
Serum bile acids
Bile acid levels in serum at end of study between groups
Time frame: 8 weeks
Serum bile acids
Bile acid levels in serum at end of study within groups compared to baseline
Time frame: 8 weeks
Serum short-chain fatty acid (SCFA) levels
SCFA levels in serum at end of study between groups
Time frame: 8 weeks
Stool short-chain fatty acid (SCFA) levels
SCFA levels in stool at end of study between groups
Time frame: 8 weeks
Serum short-chain fatty acid (SCFA) levels
SCFA levels in serum at end of study within groups compared to baseline
Time frame: 8 weeks
Stool short-chain fatty acid (SCFA) levels
SCFA levels in stool at end of study within groups compared to baseline
Time frame: 8 weeks
MELD score change within group
MELD score within groups compared to baseline
Time frame: 8 weeks
MELD score change between groups
MELD score between groups
Time frame: 8 weeks
Adherence on assigned therapy
Proportion of assigned therapy taken during the entire study between groups (%)
Time frame: 8 weeks
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