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Completed

NCT Number: NCT05424146

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 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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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in PTSD symptoms scores

    Time frame: 12 weeks

    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.

  2. Changes in microbiota community structure & function

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Cures Within Reach

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2022
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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