Printed from Voxsanity (voxsanity.com.au) — NCT06464952 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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PTSD Trial, Recruiting
NCT06464952
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are older than 18 years of age
- People who are able to read and sign a consent form agreeing to take part
- People who have been diagnosed with cirrhosis (scarring of the liver)
- People who are willing to follow all study procedures and remain available for the full duration of the study
- People who are able to swallow and take oral (by mouth) medication
- People who are willing to provide biological samples as required by the study
- People who meet a specific checklist definition of PTSD (post-traumatic stress disorder) and have an official PTSD diagnosis recorded in their medical chart by a mental health professional
Who may not be able to join:
- People who have had a confirmed COVID-19 (SARS-CoV-2) infection in the past 60 days, based on medical records
- People who do not have, or appear not to have, the capacity to give informed consent
- People who drink alcohol above recommended limits — more than 14 drinks per week for men or more than 7 drinks per week for women
- People who are currently using illegal drugs (marijuana is permitted)
- People who have used experimental drugs, biological treatments, or experimental medical devices within the past 30 days
- People who are pregnant, currently breastfeeding, or planning to become pregnant during the study period
- People who have been diagnosed with inflammatory bowel disease, Crohn's disease, or Celiac disease
- People with an unstable psychiatric condition, specifically psychosis
- People who have previously had certain bowel or stomach surgeries, including colorectal surgery, gastric bypass, or removal of part of the intestine
- People who have used prebiotics, probiotics (including yogurts containing live probiotics), postbiotics, or fibre supplements within the past 30 days
- People who have taken systemic antibiotics (antibiotics that work throughout the whole body) within the past 30 days
- People who have had a faecal microbiota transplant (a procedure involving transfer of gut bacteria) within the past 30 days
- People who have active difficulty swallowing
- People who have known allergies to any ingredients in the products being used in the study
- People who have used anti-diarrhoeal medications, stool softeners, or immune-system-affecting medications within the past 30 days
- People currently receiving treatment for hepatic encephalopathy (a brain condition related to liver disease)
- People where the trial investigators believe any other factor, condition, or medication not listed above may affect gut responses or the interpretation of study results (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
GP referral letter
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Trial details
Status
Recruiting
Phase
Not Applicable
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Registry
ClinicalTrials.gov
Start date
31 July 2024
Est. completion
25 June 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Gut microbiome Alpha Diversity between groups
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.