Dataset Information

Rationale, design, and methods: A randomized placebo-controlled trial of an immunomodulatory probiotic intervention for Veterans with PTSD.

ABSTRACT:

Background

United States military Veterans from recent conflicts are experiencing symptoms related to posttraumatic stress disorder (PTSD). Many Veterans are resistant to conventional health and mental health interventions (e.g., medication, psychotherapy). Alternative treatment approaches are needed. An underlying feature of PTSD is exaggerated inflammation, both peripherally and in the central nervous system. This inflammation is thought to play an important role in the vulnerability to, aggravation of, and persistence of PTSD symptoms. Therefore, an innovative intervention strategy would be the use of immunoregulatory/anti-inflammatory probiotics to reduce inflammation. Here we describe the rationale, design, and methods of a randomized placebo-controlled trial (RCT) of Lactobacillus rhamnosus GG (LGG; ATCC 53103) for posttraumatic stress disorder (PTSD).

Methods

This is a Phase IIa trial of LGG for United States military Veterans with PTSD, using a longitudinal, double-blind, randomized placebo-controlled design. The primary outcome measure is plasma concentration of high-sensitivity C-reactive protein.

Conclusion

Despite the fact that symptoms associated with PTSD can be disabling, individuals living with this trauma-related disorder have limited options in terms of evidence-based interventions. Recent research efforts aimed at highlighting the biological mechanisms of PTSD suggest that increased inflammation and altered autonomic nervous system activity may be treatment targets, and that immunoregulatory probiotics, such as LGG, have the potential to decrease trauma-induced inflammatory responses, as well as associated symptoms. This manuscript describes the best powered human subjects Phase IIa trial, to date, of a probiotic intervention for those living with PTSD.

SUBMITTER: Brenner LA

PROVIDER: S-EPMC9260450 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Rationale, design, and methods: A randomized placebo-controlled trial of an immunomodulatory probiotic intervention for Veterans with PTSD.

Brenner Lisa A LA Stearns-Yoder Kelly A KA Stamper Christopher E CE Hoisington Andrew J AJ Brostow Diana P DP Hoffmire Claire A CA Forster Jeri E JE Donovan Meghan L ML Ryan Arthur T AT Postolache Teodor T TT Lowry Christopher A CA

Contemporary clinical trials communications 20220628

<h4>Background</h4>United States military Veterans from recent conflicts are experiencing symptoms related to posttraumatic stress disorder (PTSD). Many Veterans are resistant to conventional health and mental health interventions (e.g., medication, psychotherapy). Alternative treatment approaches are needed. An underlying feature of PTSD is exaggerated inflammation, both peripherally and in the central nervous system. This inflammation is thought to play an important role in the vulnerability t ...[more]

PMID: 35812820

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Project description:Background: US military Veterans returned from Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) with symptoms associated with mild traumatic brain injury [mTBI; i.e., persistent post-concussive (PPC) symptoms] and posttraumatic stress disorder (PTSD). Interventions aimed at addressing symptoms associated with both physical and psychological stressors (e.g., PPC and PTSD symptoms) are needed. This study was conducted to assess the feasibility, acceptability, and safety of a probiotic intervention, as well as to begin the process of evaluating potential biological outcomes. Methods: A pilot randomized controlled trial was implemented among US military Veterans from recent conflicts in Iraq and Afghanistan. Those enrolled had clinically significant PPC and PTSD symptoms. Participants were randomized to intervention (Lactobacillus reuteri DSM 17938) or placebo supplementation (daily for 8 weeks +/- 2 weeks) at a 1:1 ratio, stratified by irritable bowel syndrome status. Thirty-one Veterans were enrolled and randomized (15 to the placebo condition and 16 to the probiotic condition). Results: Thresholds for feasibility, acceptability, and safety were met. Probiotic supplementation resulted in a decrease in plasma C-reactive protein (CRP) concentrations relative to the placebo group that approached statistical significance (p = 0.056). Although during the Trier Social Stress Test (TSST; administered post-supplementation) no between-group differences were found on a subjective measure of stress responsivity (Visual Analog Scale), there was a significantly larger increase in mean heart beats per minute between baseline and the math task for the placebo group as compared with the probiotic group (estimated mean change, probiotic 5.3 [95% Confidence Interval: -0.55, 11.0], placebo 16.9 [11.0, 22.7], p = 0.006). Conclusions: Findings from this trial support the feasibility, acceptability, and safety of supplementation with an anti-inflammatory/immunoregulatory probiotic, L. reuteri DSM 17938, among Veterans with PPC and PTSD symptoms. Moreover, results suggest that CRP may be a viable inflammatory marker of interest. A larger randomized controlled trial aimed at measuring both biological and clinical outcomes is indicated. Clinical Trial Registration: ClinicalTrials.gov, Identifier NCT02723344.

Project description:BackgroundAdverse pregnancy outcomes (APOs) identify cardiovascular disease risk, but few effective interventions are available. High sedentary behavior (SED) has recently been associated with APOs, but very few randomized controlled trials (RCTs) have tested SED reduction in pregnancy.ObjectiveThe Sedentary Behavior Reduction in Pregnancy Intervention (SPRING) pilot and feasibility RCT addresses this gap by testing the feasibility, acceptability, and preliminary pregnancy health effects of an intervention to reduce SED in pregnant women. The objective of this manuscript is to describe the rationale and design of SPRING.MethodsPregnant participants (n=53) in their first trimester, who are at risk for high SED and APO and without contraindications, are randomized in a 2:1 ratio to an intervention or control group. SED (primary outcome) and standing durations, and steps per day, are measured objectively in each trimester for 1 week with a thigh-mounted activPAL3 accelerometer. SPRING also seeks to demonstrate feasibility and acceptability while estimating preliminary effects on maternal-fetal health outcomes assessed during study visits and abstracted from medical records. The pregnancy-customized intervention promotes daily behavioral targets of less than 9 hours of SED and at least 7500 steps, achieved via increased standing and incorporating light-intensity movement breaks each hour. The multicomponent intervention provides a height-adjustable workstation, a wearable activity monitor, behavioral counseling every 2 weeks (through videoconference), and membership in a private social media group. Herein, we review the rationale, describe recruitment and screening processes, and detail the intervention, assessment protocols, and planned statistical analyses.ResultsThis study was funded by the American Heart Association (20TPA3549099), with a funding period of January 1, 2021, and until December 31, 2023. Institutional review board approval was obtained on February 24, 2021. Participants were randomized between October 2021 and September 2022, with final data collection planned for May 2023. Analyses and submission of results are expected for winter of 2023.ConclusionsThe SPRING RCT will provide initial evidence on the feasibility and acceptability of an SED-reduction intervention to decrease SED in pregnant women. These data will inform the design of a large clinical trial testing SED reduction as a strategy to reduce APO risk.Trial registrationClincialTrials.gov NCT05093842; https://clinicaltrials.gov/ct2/show/NCT05093842.International registered report identifier (irrid)DERR1-10.2196/48228.

Project description:Older adults who live in rural areas experience significant disparities in health status and access to mental health care. "Telepsychology," (also referred to as "telepsychiatry," or "telemental health") represents a potential strategy towards addressing this longstanding problem. Older adults may benefit from telepsychology due to its: (1) utility to address existing problematic access to care for rural residents; (2) capacity to reduce stigma associated with traditional mental health care; and (3) utility to overcome significant age-related problems in ambulation and transportation. Moreover, preliminary evidence indicates that telepsychiatry programs are often less expensive for patients, and reduce travel time, travel costs, and time off from work. Thus, telepsychology may provide a cost-efficient solution to access-to-care problems in rural areas.We describe an ongoing four-year prospective, randomized clinical trial comparing the effectiveness of an empirically supported treatment for major depressive disorder, Behavioral Activation, delivered either via in-home videoconferencing technology ("Telepsychology") or traditional face-to-face services ("Same-Room"). Our hypothesis is that in-homeTelepsychology service delivery will be equally effective as the traditional mode (Same-Room). Two-hundred twenty-four (224) male and female elderly participants will be administered protocol-driven individual Behavioral Activation therapy for depression over an 8-week period; and subjects will be followed for 12-months to ascertain longer-term effects of the treatment on three outcomes domains: (1) clinical outcomes (symptom severity, social functioning); (2) process variables (patient satisfaction, treatment credibility, attendance, adherence, dropout); and (3) economic outcomes (cost and resource use).Results from the proposed study will provide important insight into whether telepsychology service delivery is as effective as the traditional mode of service delivery, defined in terms of clinical, process, and economic outcomes, for elderly patients with depression residing in rural areas without adequate access to mental health services.National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT00324701).

Dataset Information

Rationale, design, and methods: A randomized placebo-controlled trial of an immunomodulatory probiotic intervention for Veterans with PTSD.

Background

Methods

Conclusion

Publications

Rationale, design, and methods: A randomized placebo-controlled trial of an immunomodulatory probiotic intervention for Veterans with PTSD.

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