Status:

COMPLETED

Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation

Lead Sponsor:

Rush University Medical Center

Collaborating Sponsors:

Cures Within Reach

Conditions:

Post Traumatic Stress Disorder

Eligibility:

All Genders

Phase:

NA

Brief 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 civ...

Eligibility Criteria

Inclusion

  • Veterans who are participating in the Rush Road Home Program 2-week Intensive Outpatient Program (IOP) and have the ability to consent.
  • Ability and willingness to consume up to two prebiotic bars daily and collect stool samples.

Exclusion

  • Active suicidality or homicidality, current engagement in significant non-suicidal self harm, history of mania or psychosis, current eating disorders, and/or current substance use that would require medical observation if discontinued.
  • Gastrointestinal disease: (1) prior intestinal resection, (2) history of GI disease (except for hiatal hernia, nonproton pump inhibitor requiring gastroesophageal reflux disease, or hemorrhoids), (3) known renal disease or abnormal liver function, (4) antibiotic use within the previous 12 weeks, (5) a plan to have a major change in dietary habits during the study.
  • Allergy to almonds, flax seed or coconuts

Key Trial Info

Start Date :

June 6 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 5 2023

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT05424146

Start Date

June 6 2022

End Date

July 5 2023

Last Update

April 16 2024

Active Locations (1)

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1

Rush University Medical Center

Chicago, Illinois, United States, 60612