Post Traumatic Stress DisorderNCT05424146
Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation
A study testing Prebiotic Bar +CPT and Non-Prebiotic Bar +CPT in people with Post Traumatic Stress Disorder, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Prebiotic Bar +CPT and Non-Prebiotic Bar +CPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 5 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Enhancing the Efficacy of Evidence-Based PTSD Treatment Via Microbiota-Directed 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Prebiotic Bar +CPT, Non-Prebiotic Bar +CPT
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic Bar +CPTDietary 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 +CPTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Non-Prebiotic Bar Group | Placebo comparator | This group of participants will be consuming non-prebiotic bars for the duration of the trial. Receives: Behavioral: Non-Prebiotic Bar +CPT |
| Prebiotic Bar Group | Active comparator | Participants will be asked to consume prebiotic bars for the duration of the trial. Receives: Dietary Supplement: Prebiotic Bar +CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start6 Jun 2022
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cures Within Reach
- Responsible party
- Principal investigator, Robin Voigt, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424146
- Sponsor's protocol ID
- ORA 21051205
- Status last verified
- Apr 2024
- First submitted
- 8 Jun 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voigt RM, Engen PA, Villanueva M, Bambi SA, Green SJ, Naqib A, Raeisi S, Shaikh M, Hamaker BR, Cantu-Jungles TM, Pridgen SA, Held P, Keshavarzian A. Prebiotics as an adjunct therapy for posttraumatic stress disorder: a pilot randomized controlled trial. Front Neurosci. 2025 Jan 7;18:1477519. doi: 10.3389/fnins.2024.1477519. eCollection 2024.
PubMed 39840022
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Efficacy of Evidence-Based PTSD Treatment Via Microbiota-Directed Prebiotic Supplementation
- ClinicalTrials.gov ID
- NCT05424146
- Acronym / sponsor ID
- ORA 21051205
- Conditions
- Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Cures Within Reach
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Non-Prebiotic Bar Group | Placebo comparator | Behavioral: Non-Prebiotic Bar +CPTThis group of participants will be consuming non-prebiotic bars for the duration of the trial. |
| Prebiotic Bar Group | Active comparator | Dietary Supplement: Prebiotic Bar +CPTParticipants will be asked to consume prebiotic bars for the duration of the trial. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic Bar +CPTParticipants 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. | Dietary supplement | Prebiotic Bar Group |
| Non-Prebiotic Bar +CPTParticipants 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. | Behavioural | Placebo Non-Prebiotic Bar Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39840022Voigt RM, Engen PA, Villanueva M, Bambi SA, Green SJ, Naqib A, Raeisi S, Shaikh M, Hamaker BR, Cantu-Jungles TM, Pridgen SA, Held P, Keshavarzian A. Prebiotics as an adjunct therapy for posttraumatic stress disorder: a pilot randomized controlled trial. Front Neurosci. 2025 Jan 7;18:1477519. doi: 10.3389/fnins.2024.1477519. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic Bar +CPT and Non-Prebiotic Bar +CPT in people with Post Traumatic Stress Disorder, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms scores (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05424146, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.