CirrhosisRESIST-PTSDNCT06464952
Microbiome Modulation With Prebiotics in PTSD and Cirrhosis
A study testing Resistant potato starch and Powdered cellulose in people with Cirrhosis and PTSD, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Resistant potato starch and Powdered cellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 25 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
Jasmohan S Bajaj, MD, 804-675-5021, jsbajaj@vcu.edu
Jasmohan S Bajaj, MD, MSc
About this study
Official title: Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation (RESIST-PTSD)
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.
- Being tested
- Resistant potato starch, Powdered cellulose
- Keywords
- microbiome, prebiotic, gut-brain, liver disease
- Medical subject headings
- Fibrosis, Stress Disorders, Post-Traumatic, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant potato starchDietary supplement
Prebiotic
Powdered celluloseDietary supplement
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Resistant potato starch | Experimental | Not described Receives: Dietary Supplement: Resistant potato starch |
| Cellulose | Active comparator | Not described Receives: Dietary Supplement: Powdered cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome Alpha Diversity between groups
Shannon diversity at end of interventions between both groups
Measured: 8 weeks
Secondary outcomes (11)
Gut microbiome Alpha Diversity within groups at study end
Shannon diversity at end of interventions within each group
Measured: 8 weeks
Gut microbiome Alpha Diversity within groups at mid-study
Shannon diversity at mid-study within each group
Measured: 4 weeks
Serum bile acids
Bile acid levels in serum at end of study between groups
Measured: 8 weeks
Serum bile acids
Bile acid levels in serum at end of study within groups compared to baseline
Measured: 8 weeks
Serum short-chain fatty acid (SCFA) levels
SCFA levels in serum at end of study between groups
Measured: 8 weeks
Stool short-chain fatty acid (SCFA) levels
SCFA levels in stool at end of study between groups
Measured: 8 weeks
Serum short-chain fatty acid (SCFA) levels
SCFA levels in serum at end of study within groups compared to baseline
Measured: 8 weeks
Stool short-chain fatty acid (SCFA) levels
SCFA levels in stool at end of study within groups compared to baseline
Measured: 8 weeks
MELD score change within group
MELD score within groups compared to baseline
Measured: 8 weeks
MELD score change between groups
MELD score between groups
Measured: 8 weeks
Adherence on assigned therapy
Proportion of assigned therapy taken during the entire study between groups (%)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start31 Jul 2024
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT in patients with cirrhosis and PTSD focused on feasibility and safety
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464952
- Sponsor's protocol ID
- BAJAJ0036
- Acronym
- RESIST-PTSD
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structure and Function of Microbiome Change in Subjects With Cirrhosis and PTSD After Potato Starch or Cellulose Supplementation (RESIST-PTSD)
- ClinicalTrials.gov ID
- NCT06464952
- Acronym / sponsor ID
- RESIST-PTSD / BAJAJ0036
- Keywords
- microbiome, prebiotic, gut-brain, liver disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT in patients with cirrhosis and PTSD focused on feasibility and safety
| Arm | Type | Receives |
|---|---|---|
| Resistant potato starch | Experimental | Dietary Supplement: Resistant potato starch |
| Cellulose | Active comparator | Dietary Supplement: Powdered cellulose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistant potato starchPrebiotic | Dietary supplement | Resistant potato starch |
| Powdered celluloseActive comparator | Dietary supplement | Cellulose |
Primary outcome
Gut microbiome Alpha Diversity between groups
Time frame: 8 weeks
Shannon diversity at end of interventions between both groups
11 secondary outcomes
Gut microbiome Alpha Diversity within groups at study end
Time frame: 8 weeks
Gut microbiome Alpha Diversity within groups at mid-study
Time frame: 4 weeks
Serum bile acids
Time frame: 8 weeks
Serum bile acids
Time frame: 8 weeks
Serum short-chain fatty acid (SCFA) levels
Time frame: 8 weeks
Stool short-chain fatty acid (SCFA) levels
Time frame: 8 weeks
Serum short-chain fatty acid (SCFA) levels
Time frame: 8 weeks
Stool short-chain fatty acid (SCFA) levels
Time frame: 8 weeks
MELD score change within group
Time frame: 8 weeks
MELD score change between groups
Time frame: 8 weeks
Adherence on assigned therapy
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistant potato starch and Powdered cellulose in people with Cirrhosis and PTSD, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome Alpha Diversity between groups (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.