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Probiotic

Probiotics for PTSD

Phase 2
Recruiting
Led By Lisa Brenner, Ph.D.
Research Sponsored by VA Eastern Colorado Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current diagnosis of Functional Bowel Disorder by ROME IV
Current diagnosis of PTSD per the Clinician Administered PTSD Scale-5 (CAPS-5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from basline to directly following the 8 week intervention
Awards & highlights

Study Summary

This trial looks at the impact of a probiotic supplement on symptoms of PTSD in veterans, in order to identify a novel intervention for the treatment of this condition.

Who is the study for?
This trial is for Veterans aged 18-60 with PTSD who have served in OEF/OIF, can provide blood and stool samples, and are not taking other probiotics. They must have a history of inflammation (CRP level ≥1.0 mg/L) and be medically cleared to participate. Exclusions include non-English speakers, recent antibiotic use, immunodeficiency conditions, certain GI surgeries or barriers, unstable diets, substance abuse issues, pregnancy/lactation among women.Check my eligibility
What is being tested?
The study tests whether the probiotic Lactobacillus rhamnosus GG (LGG) can reduce chronic PTSD symptoms by decreasing body and brain inflammation. Participants will either receive LGG or a placebo while researchers monitor changes in biomarkers of inflammation, gut microbiota composition, stress response decision making.See study design
What are the potential side effects?
While generally considered safe with minimal side effects for most people when taken as directed; potential side effects from LGG may include digestive discomfort such as gas or bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a Functional Bowel Disorder.
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I have been diagnosed with PTSD by a professional.
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I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from basline to directly following the 8 week intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from basline to directly following the 8 week intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C-reactive protein
Secondary outcome measures
Biological and psychological stress response
Decision-making
PTSD symptoms per the PTSD Checklist for DSM-5 (PCL-5)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SupplementExperimental Treatment1 Intervention
8 weeks of dietary augmentation with oral LGG 1.0 x 1010 colony forming units (CFU) once daily (delivered in a size 1 capsule)
Group II: PlaceboPlacebo Group1 Intervention
8 weeks of dietary augmentation with placebo once daily (delivered in a size 1 capsule)

Find a Location

Who is running the clinical trial?

VA Eastern Colorado Health Care SystemLead Sponsor
53 Previous Clinical Trials
26,028 Total Patients Enrolled
University of Colorado, DenverOTHER
1,738 Previous Clinical Trials
2,149,376 Total Patients Enrolled
University of Colorado, BoulderOTHER
119 Previous Clinical Trials
29,044 Total Patients Enrolled

Media Library

Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766) (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04150380 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Supplement, Placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766) Highlights & Side Effects. Trial Name: NCT04150380 — Phase 2
Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766) (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04150380 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04150380 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for enrollees in this research trial?

"Affirmative. Clinicaltrials.gov attests to the fact that this medical experiment, which was first posted on August 24th 2020 is still actively recruiting individuals. 150 volunteers are required for the single site running this trial."

Answered by AI

What risks have been associated with Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766)?

"Taking into account the existing safety data, we assigned Lactobacillus rhamnosus GG (LGG; ATCC strain 53103; CRMTS #11272; PTS #3766) a score of 2. This is due to this being a Phase 2 trial indicating some evidence of safety but no proof that it is efficacious."

Answered by AI

Is participation in this research still available for volunteers?

"According to the information hosted on clinicaltrials.gov, this study is currently recruiting participants. It was first announced on August 24th 2020 and has since been revised up until October 11th 2021."

Answered by AI

To which demographic is participation in this trial open?

"This clinical trial seeks 150 participants aged between 18 and 60 that are currently suffering from inflammation. Other requirements include a willingness to not take any probiotic supplements (including pills, tablets, oils or foods) in addition to those provided by the study until completion of all relevant procedures, having been deployed for Operation Enduring Freedom/Operation Iraqi Freedom at least once prior and medical clearance from our specialist doctors."

Answered by AI

Does the eligibility criteria for this research study encompass individuals below eighty years of age?

"This research study has established a target demographic of patients aged 18 to 60. For those under the age limit, there are 73 trials available while 592 studies welcome individuals over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
VA Rocky Mountain Regional Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

It wears on my mental self daily. I find studies having to do with micro biome very interesting and prefer them over other routes.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How early are the screening visits and if I travel do I get compensation? How much does this trial compensate ?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Probiotic (LGG) for Veterans With PTSD
Lisa Brenner 2020. "Probiotic (LGG) for Veterans With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04150380.
~23 spots leftby Dec 2024
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