Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424146
• Other study ID #: ORA 21051205
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: July 5, 2023

Study information

• Verified date: April 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Cures Within Reach

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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