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NCT05424146 · ClinicalTrials.gov registry record · NA
Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation
A NA study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT05424146: Completed NA study, sponsored by Rush University Medical Center.
NCT05424146 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05424146, a NA study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder, which results from exposure to traumatic events. Veterans are more than twice as likely to suffer from PTSD compared to civilians. Current interventions for the treatment of PTSD are evidence-based psychotherapies, such as Cognitive Processing Therapy (CPT). Therefore, we plan to compare Cognitive Processing Therapy (CPT) with and without a novel prebiotic bar designed to beneficially modulate the microbiota to determine the utility of this combined approach to positively impact PTSD symptoms. We will conduct a 12-week randomized, double-blind, placebo-controlled, cross-sectional trial in veterans with PTSD. Participants will be randomized to receive CPT + prebiotic or CPT + placebo. They will be provided a supply of prebiotic or non prebiotic bars for 12 weeks. At three different time points, participants will complete questionnaires and complete questionnaires and produce a stool sample ( weeks 1,2, and 12). All participants will be recruited from the two-week in-person Intensive Outpatient Program (IOP) at the Rush Road Home Program, where they will be receiving CPT.
Primary Outcome
PTSD symptoms will be assessed using the PTSD Checklist- Identified Patient Version (PCL-5), a 20-item self-report measure of the 20 DSM-5 symptoms of PTSD. Respondents are asked to rate how bothered they have been by each of 20 items in the past month using a Likert scale ranging from 0-4, where 0= Not at All, 1= A little Bit, 2= Moderate, 3= Quite a Bit, and 4= Extremely. These scores are summed to provide a total severity score (range = 0-80). A score of 38 is considered a provisional PTSD di
Interventions
- DIETARY_SUPPLEMENT Prebiotic Bar +CPT
- BEHAVIORAL Non-Prebiotic Bar +CPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-06-06 |
| Est. Completion | 2023-07-05 |
| Phase | NA |
What the finished NCT05424146 record still lists
NCT05424146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Prebiotic Bar +CPT is the first listed.
NCT05424146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05424146 about?
NCT05424146 is a clinical study titled "Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation". Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder, which results from exposure to traumatic events. Veterans are more than twice as likely to suffer from PTSD compared to civilians. Current interventions for the treatment of PTSD are evidence-based psychotherapies, such as ...
What is the current status of trial NCT05424146?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2022-06-06. Estimated completion is 2023-07-05.
What interventions are being tested in trial NCT05424146?
The interventions under investigation include: Prebiotic Bar +CPT (DIETARY_SUPPLEMENT), Non-Prebiotic Bar +CPT (BEHAVIORAL).
Who is sponsoring clinical trial NCT05424146?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05424146's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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