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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 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 80 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05424146
The ClinicalTrials.gov registry entry for NCT05424146 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prebiotic Bar +CPT is the first listed.
NCT05424146 reports 0 study locations.
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.
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