What side effects are associated with this type of intervention?

Common treatments for PTSD include cognitive behavioral therapy (CBT), exposure therapy, and medications such as selective serotonin reuptake inhibitors (SSRIs). Side effects of CBT and exposure therapy are generally minimal but can include temporary increases in anxiety or distress. SSRIs can cause side effects like nausea, insomnia, and sexual dysfunction. For treatments similar to Lactobacillus rhamnosus GG, which is being studied for its immunoregulatory and anti-inflammatory properties, potential side effects include gastrointestinal issues such as bloating and gas, and in rare cases, systemic infections, especially in immunocompromised individuals.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications work by modulating neurotransmitter levels to alleviate symptoms of PTSD. While there are ongoing studies investigating the use of probiotics like Lactobacillus rhamnosus GG for their immunoregulatory and anti-inflammatory effects, there are currently no FDA-approved treatments for PTSD that specifically target these mechanisms. The exploration of probiotics represents a novel approach that differs from the traditional pharmacological treatments approved by the FDA.

What other types of research exist?

Lactobacillus plantarum MTCC 9510 is a promising alternative, as it has shown potential in modulating gut microbiota and preventing stress-induced pathological alterations in animal models. Additionally, synbiotics combining probiotics like Bifidobacterium breve M-16V with prebiotics (e.g., galacto-oligosaccharides and fructo-oligosaccharides) have demonstrated benefits in reducing inflammation and improving immune responses, which could be beneficial for PTSD patients.

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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)

Must not have

Use of any of the following drugs within the last 6 months: antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral); oral, intravenous, intramuscular, or inhaled corticosteroids; cytokines or cytokine inhibitors; methotrexate or immunosuppressive cytotoxic agents

History of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from basline to directly following the 8 week intervention

Summary

This trial investigates using a beneficial bacteria called Lactobacillus rhamnosus GG (LGG) to help U.S. military Veterans with PTSD who do not respond well to traditional treatments. The probiotic aims to reduce inflammation in the body and brain, which is a common issue in PTSD. By balancing gut bacteria, it may improve PTSD symptoms and overall stress response. Lactobacillus rhamnosus GG (LGG) has shown several beneficial effects, including improved insulin sensitivity and anti-inflammatory properties.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken antifungals, antivirals, steroids, or immunosuppressants in the last 6 months.

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I have had cancer in the past.

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I do not speak English.

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I have a condition or am taking medication that weakens my immune system.

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I have been treated for or suspected of having toxic shock syndrome.

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I have never been diagnosed with bipolar, psychosis, or anxiety disorders (PTSD excluded).

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I am currently pregnant or breastfeeding.

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I have had a serious head injury in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from basline to directly following the 8 week intervention

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

C-reactive protein

Secondary study objectives

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)

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Traumatic Stress Disorder (PTSD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which work by increasing the levels of serotonin and norepinephrine in the brain to improve mood and reduce anxiety. Prazosin, an alpha-adrenergic receptor blocker, is used to alleviate nightmares and sleep disturbances by reducing the effects of adrenaline. Probiotics like Lactobacillus rhamnosus GG are being studied for their immunoregulatory and anti-inflammatory properties, which may help reduce the exaggerated inflammation seen in PTSD patients. These treatments are crucial as they target both the psychological and physiological aspects of PTSD, potentially leading to more comprehensive symptom relief.

Adjunctive Minocycline for Treatment of Posttraumatic Stress Disorder.