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Prebiotic

Prebiotics for PTSD and Liver Cirrhosis (RESIST-PTSD Trial)

N/A
Recruiting
Research Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Cirrhosis diagnosis
Must not have
Fecal microbiota transplant in the last 30 days
Systemic antibiotics in the last 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

"This trial investigates the relationship between PTSD, cirrhosis, and gut microbiome in Veterans. Patients with both PTSD and cirrhosis have greater cognitive impairment and changes in gut microbiome compared to those

Who is the study for?
This trial is for Veterans with PTSD and liver cirrhosis, focusing on those who may have cognitive impairments and altered gut microbiomes. It's not suitable for individuals without these specific conditions or those who cannot safely consume dietary supplements.
What is being tested?
The study tests the effects of powdered cellulose and resistant potato starch as prebiotics to improve gut health in patients with both PTSD and cirrhosis. The goal is to see if these natural fibers can positively affect the gut-brain axis.
What are the potential side effects?
Resistant starches are generally well-tolerated with few adverse reactions reported. Side effects might include digestive discomfort but are expected to be minimal based on previous studies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been diagnosed with cirrhosis.
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I have been diagnosed with PTSD by a mental health professional.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a fecal transplant in the last 30 days.
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I have not taken antibiotics in the last 30 days.
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I am currently receiving treatment for brain function issues due to liver disease.
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I am unable to understand or make decisions about my health care.
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I have been diagnosed with an inflammatory bowel condition.
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I have had surgery on my digestive system.
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I have difficulty swallowing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gut microbiome Alpha Diversity between groups
Secondary outcome measures
Adherence on assigned therapy
Gut microbiome Alpha Diversity within groups at mid-study
Gut microbiome Alpha Diversity within groups at study end
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Resistant potato starchExperimental Treatment1 Intervention
Group II: CelluloseActive Control1 Intervention

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Who is running the clinical trial?

Hunter Holmes Mcguire Veteran Affairs Medical CenterLead Sponsor
36 Previous Clinical Trials
21,576 Total Patients Enrolled
9 Trials studying Liver Cirrhosis
430 Patients Enrolled for Liver Cirrhosis
~20 spots leftby Jun 2025
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