NCT03494725

Stress & Anxiety Dampening Effects of a Probiotic Supplement Compared to Placebo in Healthy Subjects

Proof-of-Concept "Stress & Anxiety Dampening Effects of Lpc-37"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Daacro · Network
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess whether a 5 week intake of a probiotic (Lpc-37) can modulate stress and anxiety experienced by healthy subjects during and after an acute stressor compared to placebo. To measure stress and anxiety, markers of the hypothalamic-pituitary-adrenal (HPA) axis activity and questionnaires will be assessed before, during and after the Trier Social Stress Test (TSST). The results of this study indicate if the chosen study design is suitable to discover stress-related effects of probiotics.

Detailed description

The total mass of microorganisms residing within the human intestine is approximately the same as that of the human brain. Of late, these \>1000 species and \>7000 strains have been described as the "brain in our belly" because of the essential role they play in physiological and psychological health and disease. The gut-brain axis describes the bidirectional communication that exists between the brain and the gut and the microbiota-gut-brain axis supports the role of the gut microbiome in this communication system. Emotional and routine daily life stress can disrupt digestive function, but increasing evidence indicates that the gut microbiota exert a profound influence on brain physiology, psychological responses and ultimately behavior. A plethora of literature to date, albeit predominantly preclinical, have demonstrated evidence to support the role of the gut microbiome in regulating stress-related changes in physiology, behavior and brain function. Stress is an individual process to deal with external and internal challenges that ranges from behavioral to molecular adaptations. The HPA axis and its release of stress hormones plays a major role in stress adaptation. The purpose of this clinical trial is to determine whether a single strain of bacteria derived from the species Lacticaseibacillus paracasei Lpc-37 (Lpc-37), formerly Lactobacillus paracasei Lpc-37, can modulate stress experienced by healthy subjects exposed to the TSST measured by HPA axis activation markers and self-report questionnaires.

Conditions

• Healthy
• Stress, Psychological

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lpc-37	Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10\^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide
DIETARY_SUPPLEMENT	Placebo	microcrystalline cellulose, magnesium stearate, silicon dioxide

Timeline

• Start date: 2018-04-10
• Primary completion: 2018-10-09
• Completion: 2018-10-09
• First posted: 2018-04-11
• Last updated: 2021-02-25
• Results posted: 2021-02-25

Locations

1 site across 1 country: Germany