Prebiotic Bar Group for Moral Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rush University Medical Center, Chicago, IL
Moral Injury+2 More
Prebiotic Bar +CPT - DietarySupplement
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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 78 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.

Eligible Conditions

  • Moral Injury
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Moral Injury

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 12 weeks

12 weeks
Change in PTSD symptoms scores
Changes in microbiota community structure & function

Trial Safety

Safety Progress

1 of 3

Other trials for Moral Injury

Trial Design

2 Treatment Groups

Prebiotic Bar Group
1 of 2
Placebo Non-Prebiotic Bar Group
1 of 2
Active Control
Non-Treatment Group

78 Total Participants · 2 Treatment Groups

Primary Treatment: Prebiotic Bar Group · Has Placebo Group · N/A

Placebo Non-Prebiotic Bar Group
Behavioral
PlaceboComparator Group · 1 Intervention: Non-Prebiotic Bar +CPT · Intervention Types: Behavioral
Prebiotic Bar Group
DietarySupplement
ActiveComparator Group · 1 Intervention: Prebiotic Bar +CPT · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Trial Background

Robin Voigt, Principal Investigator
Principal Investigator
Rush University Medical Center
Closest Location: Rush University Medical Center · Chicago, IL
Photo of rush university medical center  1Photo of rush university medical center  2Photo of rush university medical center  3
2011First Recorded Clinical Trial
0 TrialsResearching Moral Injury
790 CompletedClinical Trials

Eligibility Criteria

Age Any Age · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to consume up to two prebiotic bars daily and collect stool samples.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.