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New treatment option for Cirrhosis
Official title Microbiome Modulation With Prebiotics in PTSD and Cirrhosis
ClinicalTrials.gov ID: NCT06464952
What this study is testing
- What it's testing
- Despite medical advancements, PTSD remains a major issue in Veterans1. Current treatment strategies have relatively poor adherence.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Known SARS-CoV-2 infection in the last 60 days using medical records
- people 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
See the full eligibility criteria
- 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
- Known SARS-CoV-2 infection in the last 60 days using medical records
- people 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.