Stress & Anxiety Dampening Effects of a Probiotic Supplement Compared to Placebo in Healthy Subjects
NCT ID: NCT03494725
Last Updated: 2021-02-25
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-04-10
Study Completion Date
2018-10-09
Brief Summary
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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.
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Detailed Description
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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.
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
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Healthy
Stress, Psychological
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Lpc-37
Lacticaseibacillus paracasei Lpc-37 (Lpc-37), formerly Lactobacillus paracasei Lpc-37
1x 1 capsule in the morning for 5 weeks
Group Type
ACTIVE_COMPARATOR
Lpc-37
Intervention Type
DIETARY_SUPPLEMENT
Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10\^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide
Placebo
Placebo capsule manufactured to mimic Lpc-37 capsule
1x 1 capsule in the morning for 5 weeks
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DIETARY_SUPPLEMENT
microcrystalline cellulose, magnesium stearate, silicon dioxide
Interventions
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Lpc-37
Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10\^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide
Intervention Type
DIETARY_SUPPLEMENT
Placebo
microcrystalline cellulose, magnesium stearate, silicon dioxide
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* Voluntary, written, informed consent to participate in the study
* Male or female aged between 18-45 years (inclusive)
* Body mass index (BMI) between 18.5 - 29.9 kg/m2
* Medical examination at baseline indicates they are healthy in the opinion of the investigator
* Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
* Agreement to comply with the protocol and study restrictions
* Available for all study visits
* Females of child-bearing potential required to provide a negative urine pregnancy test and to use contraceptives
* Easy access to internet
* Male or female aged between 18-45 years (inclusive)
* Body mass index (BMI) between 18.5 - 29.9 kg/m2
* Medical examination at baseline indicates they are healthy in the opinion of the investigator
* Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
* Agreement to comply with the protocol and study restrictions
* Available for all study visits
* Females of child-bearing potential required to provide a negative urine pregnancy test and to use contraceptives
* Easy access to internet
Exclusion Criteria
* Self-reported diagnosis of one or more Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV axis 1 disorder(s), including but not limited to current major depression, anxiety disorder, bipolar spectrum disorder or schizophrenia
* Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic, neurodevelopmental or any condition which contraindicates, in the Investigator's judgement, entry to the study
* Currently taking (from day of screening onwards) or have previously taken (last 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
* Currently taking (from day of screening onwards) medication or dietary supplements that the Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, omega-3 dietary supplements, non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter (OTC) sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, proton pump inhibitors, anti-histamines, pseudoephedrine, cortisone, beta-blockers)
* Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period
* Daily consumption of concentrated sources of probiotics and/or prebiotics within 2 weeks of screening and throughout the intervention period other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders)
* Pregnant or lactating female, or pregnancy planned during intervention period
* Not fluent in German
* Have self-reported dyslexia
* History of alcohol, drug, or medication abuse
* Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period
* Contraindication to any substance in the investigational product
* Hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
* Known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
* Subjects having previously participated in the TSST
* Smoking \> 5 cigarettes/day
* Employee of the sponsor or contract research organization (CRO)
* Participation in another study with any investigational product within 60 days of screening and during the intervention period
* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
* Participant under administrative or legal supervision
* Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic, neurodevelopmental or any condition which contraindicates, in the Investigator's judgement, entry to the study
* Currently taking (from day of screening onwards) or have previously taken (last 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
* Currently taking (from day of screening onwards) medication or dietary supplements that the Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results (e.g. melatonin, omega-3 dietary supplements, non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter (OTC) sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, proton pump inhibitors, anti-histamines, pseudoephedrine, cortisone, beta-blockers)
* Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period
* Daily consumption of concentrated sources of probiotics and/or prebiotics within 2 weeks of screening and throughout the intervention period other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders)
* Pregnant or lactating female, or pregnancy planned during intervention period
* Not fluent in German
* Have self-reported dyslexia
* History of alcohol, drug, or medication abuse
* Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period
* Contraindication to any substance in the investigational product
* Hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
* Known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months)
* Subjects having previously participated in the TSST
* Smoking \> 5 cigarettes/day
* Employee of the sponsor or contract research organization (CRO)
* Participation in another study with any investigational product within 60 days of screening and during the intervention period
* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
* Participant under administrative or legal supervision
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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DuPont Nutrition and Health
INDUSTRY
Sponsor Role
collaborator
Daacro
NETWORK
Sponsor Role
lead
Responsible Party
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Juliane Hellhammer
PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Juliane Hellhammer, PhD
Role: PRINCIPAL_INVESTIGATOR
Daacro GmbH & Co. KG
Locations
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daacro GmbH & Co. KG
Trier, Rhineland-Palatinate, Germany
Site Status
Countries
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Germany
References
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Takada M, Nishida K, Kataoka-Kato A, Gondo Y, Ishikawa H, Suda K, Kawai M, Hoshi R, Watanabe O, Igarashi T, Kuwano Y, Miyazaki K, Rokutan K. Probiotic Lactobacillus casei strain Shirota relieves stress-associated symptoms by modulating the gut-brain interaction in human and animal models. Neurogastroenterol Motil. 2016 Jul;28(7):1027-36. doi: 10.1111/nmo.12804. Epub 2016 Feb 20.
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Takai N, Yamaguchi M, Aragaki T, Eto K, Uchihashi K, Nishikawa Y. Effect of psychological stress on the salivary cortisol and amylase levels in healthy young adults. Arch Oral Biol. 2004 Dec;49(12):963-8. doi: 10.1016/j.archoralbio.2004.06.007.
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Tillisch K, Labus J, Kilpatrick L, Jiang Z, Stains J, Ebrat B, Guyonnet D, Legrain-Raspaud S, Trotin B, Naliboff B, Mayer EA. Consumption of fermented milk product with probiotic modulates brain activity. Gastroenterology. 2013 Jun;144(7):1394-401, 1401.e1-4. doi: 10.1053/j.gastro.2013.02.043. Epub 2013 Mar 6.
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Tsigos C, Chrousos GP. Hypothalamic-pituitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002 Oct;53(4):865-71. doi: 10.1016/s0022-3999(02)00429-4.
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Patterson E, Griffin SM, Ibarra A, Ellsiepen E, Hellhammer J. Lacticaseibacillus paracasei Lpc-37(R) improves psychological and physiological markers of stress and anxiety in healthy adults: a randomized, double-blind, placebo-controlled and parallel clinical trial (the Sisu study). Neurobiol Stress. 2020 Nov 24;13:100277. doi: 10.1016/j.ynstr.2020.100277. eCollection 2020 Nov.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://www.daacro.de
daacro homepage
Other Identifiers
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DU01-2017
Identifier Type: -
Identifier Source: org_study_id
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