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CompletedNCT04150380

Probiotic (LGG) for Veterans With PTSD

This study is completed. It focuses on PTSD and currently lists study information in the United States.

PTSD, InflammationBiologicalFrom 18 Years to 60 Years
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In plain English

Key information made simple

What is this study testing?

This study is testing whether Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766) may be useful for adults experiencing ptsd.

What would participation involve?

Participants may complete study activities around Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766), complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for adults with ptsd.

What should you check before joining?

Ask about whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

What to expect

Your next step

The official record does not clearly describe the visit format, so the practical details are best checked directly in the source. Participation appears to involve study activities and follow-up chosen by the research team. The main fit and exclusions are best confirmed in the eligibility section of the official record. The phase details are not clearly stated here.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: August 24, 2020
Recruitment status
Completed
Estimated enrollment
383
Sponsor
VA Eastern Colorado Health Care System
Sponsor type
Unknown or unclear
Study type
Biological
Intervention type
BIOLOGICAL, OTHER
Study phase
PHASE2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States
Age range
From 18 Years to 60 Years
Official registry ID
NCT04150380
Official title
Biological Signature and Safety of an Immunomodulatory Probiotic Intervention for Veterans With PTSD
Official source
Official registry link

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Study ID: NCT04150380. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

Based on the public registry summary, this study is trying to understand: 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. The study team can confirm the exact objective and what it means for you.

Does this study involve biological samples, imaging, or biomarkers?

This appears to be a biological / biomarker / imaging study involving Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766), Placebo. The listed phase is PHASE2. Ask the study team what that means in practice for safety, monitoring, and criteria.

Who might this study be for?

This study may concern people with ptsd; age range: From 18 Years to 60 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to provide biological samples, complete lab tests, or take part in imaging or measurement procedures. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What should I check about samples, imaging, data, and possible discomfort?

If the study involves samples, imaging, or biomarkers, ask what is collected, how it is stored, who can access results, whether there may be discomfort, and whether results are shared with you. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by VA Eastern Colorado Health Care System, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is completed. It may still be useful for understanding the research, but you are unlikely to be able to join. The registry lists an estimated enrollment of 383 participants.

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