NCT05424146

Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation

Enhancing the Efficacy of Evidence-Based PTSD Treatment Via Microbiota-Directed Prebiotic Supplementation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prebiotic Bar +CPT	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.
BEHAVIORAL	Non-Prebiotic Bar +CPT	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.

Timeline

• Start date: 2022-06-06
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2022-06-21
• Last updated: 2024-04-16

Locations

1 site across 1 country: United States