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| Name | Class |
|---|---|
| Cures Within Reach | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Non-Prebiotic Bar Group | Placebo Comparator | This group of participants will be consuming non-prebiotic bars for the duration of the trial. |
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| Prebiotic Bar Group | Active Comparator | Participants will be asked to consume prebiotic bars for the duration of the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic Bar +CPT | Dietary Supplement | Participants will be instructed to consume 1 prebiotic bar once daily for 1 week CPT. Starting week 2 they will be asked to consume 1 prebiotic bar twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms scores | 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 diagnosis, the higher the scores the worse the PTSD symptoms. This questionnaire will be administered at three-time points - week 1, week 2, and week 12 to determine the time course of PTSD symptom change. Meaningful changes in symptoms will be defined as a 10-point change in the PCL-5. | 12 weeks |
| Changes in microbiota community structure & function | Stool microbiota community structure will be assessed via 16S sequencing of the V4 region to characterize the intestinal microbiota communities to the genus level. Microbiota function assessed via targeted metabolomics analysis of Short Chain Fatty Acids in stool and serum (LC-MS). Stool samples are collected at three time points- week 1, week2, and week 12 to determine the time-course change. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39840022 | Derived | Voigt RM, Engen PA, Villanueva M, Bambi SA, Green SJ, Naqib A, Raeisi S, Shaikh M, Hamaker BR, Cantu-Jungles TM, Pridgen SA, Held P, Keshavarzian A. Prebiotics as an adjunct therapy for posttraumatic stress disorder: a pilot randomized controlled trial. Front Neurosci. 2025 Jan 7;18:1477519. doi: 10.3389/fnins.2024.1477519. eCollection 2024. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2022 | Jun 8, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Non-Prebiotic Bar +CPT | Behavioral | Participants will be instructed to consume 1 non-prebiotic bar once daily for 1 week while receiving CPT. Starting week 2 they will be asked to consume 1 non-prebiotic bar twice daily. |
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