Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 majoritively 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03494725
Study type Interventional
Source Daacro
Contact Juliane Hellhammer, PhD
Phone +496519120494
Email info@daacro.de
Status Recruiting
Phase N/A
Start date April 10, 2018
Completion date October 2018

See also
  Status Clinical Trial Phase
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Recruiting NCT03662100 - A Study of Two Formulations of LY3074828 in Healthy Participants Phase 1
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Recruiting NCT03670082 - Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Phase 1
Not yet recruiting NCT03656952 - A Phase 1 Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers Phase 1
Completed NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Completed NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Recruiting NCT03114839 - Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN) N/A
Completed NCT03259464 - This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated Phase 1
Completed NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Completed NCT03309566 - Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir Phase 4
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Completed NCT03373162 - Functional Effects of Botox on the Brain Using MRS and fMRI Phase 4
Active, not recruiting NCT02509494 - Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2 Phase 3
Terminated NCT02555085 - Single Ascending Doses of BIIB063 in Healthy Volunteers Phase 1
Completed NCT03125018 - Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX) N/A
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT00004556 - The Effects of Dextroamphetamine on Brain Function