What is the mechanism of action of this treatment?

Common treatments for stress include probiotics, which influence the gut-brain axis. Probiotics can modulate the gut microbiota, leading to the production of neurotransmitters and other signaling molecules that affect brain function and stress response. This is particularly relevant for stress patients as it offers a potential non-pharmacological approach to managing stress by improving gut health, which in turn can enhance mental well-being and reduce stress levels.

What side effects are associated with this type of intervention?

Probiotics, which are being studied for their potential to reduce stress by influencing the gut-brain axis, are generally considered safe with few side effects. The most common side effects include mild digestive symptoms such as gas, bloating, and diarrhea. These symptoms are usually temporary and resolve as the body adjusts to the probiotics. In rare cases, individuals with compromised immune systems or severe illnesses may experience more serious side effects, and they should consult a healthcare provider before starting probiotic supplementation.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments that target stress by influencing the gut-brain axis, such as probiotics. Most FDA-approved treatments for stress and related conditions, like anxiety and depression, include medications such as selective serotonin reuptake inhibitors (SSRIs), benzodiazepines, and other antidepressants. While probiotics and prebiotics are being studied for their potential benefits on stress through the gut-brain axis, they have not yet received FDA approval for this specific use.

What other types of research exist?

<ol> <li>Low-FODMAP Diet: This diet reduces fermentable carbohydrates that can exacerbate gastrointestinal symptoms, potentially improving overall well-being and stress levels.</li> <li>Psychological Interventions: Cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) have shown efficacy in reducing stress and improving gut health.</li> <li>Antidepressants: Selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) can help manage stress and associated gastrointestinal symptoms.</li> <li>Physical Activity: Regular exercise has been demonstrated to improve stress levels and gastrointestinal function.</li> <li>Complementary Therapies: Acupuncture and herbal remedies like Banxiaxiexin Tang have shown promise in managing stress and gastrointestinal symptoms.</li> </ol>

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Probiotic Blend for Teen Stress (TEEN Trial)

Phase 2

Waitlist Available

Led By David Crowley, M.D

Research Sponsored by Lallemand Health Solutions

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 63 days

Awards & highlights

Summary

This trial tests whether a mix of good bacteria (probiotics) can reduce stress in teenagers who feel moderately stressed. Participants will take the probiotics for a few months and have regular check-ins. The idea is that these good bacteria might help balance the gut, which could make the participants feel less stressed. Probiotics have been reported to exert beneficial effects along the gut-brain axis, reducing symptoms of stress.

Who is the study for?

This trial is for teens aged 13-17 with moderate stress, not pregnant or planning to become so, and willing to use birth control if sexually active. They must be attending school, speak English fluently, agree to avoid certain products like probiotic supplements during the study, and maintain their lifestyle habits. Teens with mental health disorders or significant medical conditions are excluded.

What is being tested?

The study aims to see if a special blend of probiotics can help reduce stress in moderately stressed teenagers compared to a placebo. Participants will either receive the probiotic blend or a placebo and their stress levels will be monitored to determine any differences between the two groups.

What are the potential side effects?

While specific side effects aren't listed for this trial, common side effects from taking probiotics may include digestive discomfort such as gas or bloating. Since it's a natural supplement being tested against a placebo, severe side effects are unlikely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 63 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~63 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in stress at day 56 from baseline

Secondary study objectives

Change in daytime sleepiness from baseline

Change in gastrointestinal symptoms from baseline

Change in mood from baseline

+8 more

Other study objectives

Adverse events

Clinically relevant vital signs - blood pressure

Clinically relevant vital signs - heart rate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ProbioticExperimental Treatment1 Intervention

Participants will be randomized to receive the probiotic blend for 56 days.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive the placebo for 56 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Probiotic Blend

2023

Completed Phase 2

~30

Do I qualify?Apply below to find out

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 stress include probiotics, which influence the gut-brain axis. Probiotics can modulate the gut microbiota, leading to the production of neurotransmitters and other signaling molecules that affect brain function and stress response. This is particularly relevant for stress patients as it offers a potential non-pharmacological approach to managing stress by improving gut health, which in turn can enhance mental well-being and reduce stress levels.

Evaluation of an Immunomodulatory Probiotic Intervention for Veterans With Co-occurring Mild Traumatic Brain Injury and Posttraumatic Stress Disorder: A Pilot Study.

Find a Location

Who is running the clinical trial?

KGK Science Inc.Industry Sponsor

78 Previous Clinical Trials

6,130 Total Patients Enrolled

Lallemand Health SolutionsLead Sponsor

41 Previous Clinical Trials

3,948 Total Patients Enrolled

Erin Lewis, Ph.D.Study DirectorKGK Science Inc.

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05766306 — Phase 2

Stress Research Study Groups: Probiotic, Placebo

Stress Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05766306 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766306 — Phase 2

~12 spots leftby Sep 2025

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