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NCT06464952 · ClinicalTrials.gov registry record · NA
Microbiome Modulation With Prebiotics in PTSD and Cirrhosis
A NA study of PTSD and Cirrhosis, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06464952 is a NA study of PTSD and Cirrhosis that is actively recruiting participants, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 30 participants, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06464952, a NA study of PTSD and Cirrhosis, is actively recruiting participants, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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. 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 p
Interventions
- DIETARY_SUPPLEMENT Resistant potato starch
- DIETARY_SUPPLEMENT Powdered cellulose
Study Locations (1)
Virginia
- Hunter Holmes McGuire VA Medical Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-07-31 |
| Est. Completion | 2025-09-25 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06464952
The ClinicalTrials.gov registry entry for NCT06464952 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 302-participant average among 154 other PTSD trials with a reported enrollment target (90% lower). The listed sponsor is Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Resistant potato starch is the first listed.
NCT06464952 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT06464952 about?
NCT06464952 is a clinical study titled "Microbiome Modulation With Prebiotics in PTSD and Cirrhosis". 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 co...
What is the current status of trial NCT06464952?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-07-31. Estimated completion is 2025-09-25.
What conditions does trial NCT06464952 study?
This clinical trial studies the following conditions: PTSD, Cirrhosis.
What interventions are being tested in trial NCT06464952?
The interventions under investigation include: Resistant potato starch (DIETARY_SUPPLEMENT), Powdered cellulose (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06464952?
This trial is sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06464952 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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