An interventional study of Resistant potato starch and Powdered cellulose in Cirrhosis and PTSD, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center · Not applicable, Interventional, and Supportive care
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Hunter Holmes Mcguire Veteran Affairs Medical Center is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Compared within Stress Disorders, Post-Traumatic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Resistant potato starch
Dietary Supplement: Powdered cellulose
Prebiotic
Active comparator
Gut 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
Started Jul 2024 (actual). Primary completion is estimated for Jun 2027, 34 months after the start.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 34 months is close to that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Resistant Potato Starch
Stress Disorders, Post-Traumatic →
Hunter Holmes Mcguire Veteran Affairs Medical Center