Probiotic (LGG) for Veterans With PTSD (NCT04150380) | Clinical Trial Compass
CompletedPhase 2
Probiotic (LGG) for Veterans With PTSD
United States383 participantsStarted 2020-08-24
Plain-language summary
Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability to and aggravation and perpetuation of adverse consequences among those with posttraumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic, Lactobacillus rhamnosus GG (LGG; ATCC53103), to treat chronic symptoms associated with PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by biomarkers of inflammation, gut microbiota composition, intestinal permeability, stress response, decision making, and PTSD symptoms, this study may identify a novel intervention for the treatment of symptoms associated with this frequently occurring condition.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
* History of at least one deployment in support of OEF/OIF
* Current diagnosis of PTSD per the Clinician Administered PTSD Scale-5 (CAPS-5)
* Current diagnosis of Functional Bowel Disorder by ROME IV
* CRP level of 1.0 mg/L or above at baseline
* Medical clearance to participate by study providers
* Age between 18 and 60
* Ability to provide informed consent
* Willingness to abstain from probiotic supplements (pills, tablets, oils, foods, etc.) other than the investigational product provided until all study procedures are completed
* Willingness to provide blood and stool samples
Exclusion criteria
* Inability to adequately respond to questions regarding the informed consent procedure
* Currently involved in the criminal justice system as a prisoner or ward of the state
* Non-English speaking
* Current (past month) alcohol or substance abuse or dependence
* Lifetime history of bipolar disorder or psychosis or anxiety disorders (excluding PTSD).
* Consistent (e.g., 5x/week or greater) probiotic supplementation within the last month, including probiotic food products such as yogurt, as determined by phone screen interview and Probiotic Food Check List
* Receiving intravenous, intramuscular, or oral antibiotics within the last month
* Presence of central venous catheters (CVCs)
* Gastrointestinal (GI) barriers as identified by the 2-week run-in period as determined by the study team
* Participation in conflicting interventional research protocol
* Vital sig…
What they're measuring
1
Plasma concentration of C-reactive protein (CRP)
Timeframe: Change from basline to directly following the 8 week intervention