A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress

NCT04125810 | Completed Phase 2

• 1 other identifier: NH03821
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this clinical trial is to determine whether Probiotic can modulate the psychological stress experienced by healthy medical, dental and health science students preparing for university/institute of technology semester examination (s), measured by self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.

Conditions

Stress, Psychological; Healthy

Keywords

Probiotic; Stress; Gut-brain axis

Outcome Measures

Primary Outcomes (1)

• State Trait Anxiety Inventory (STAI)-state total score

  Absolute change in STAI-state total score between the active versus placebo group

  from baseline to 8 weeks

Secondary Outcomes (20)

• Change in Cortisol awakening response (CAR)

  from baseline to 8 weeks

• Change in perceived stress (Visual Analog Scale (VAS)-stress)

  from baseline to 8 weeks

• Change in DASS-21, depression scale score from baseline (Visit 3) to 8 weeks (Visit 5)

  from baseline to 8 weeks

• Change in DASS-21, anxiety scale score from baseline (Visit 3) to 8 weeks (Visit 5)

  from baseline to 8 weeks

• Change in DASS-21, stress scale score from baseline (Visit 3) to 8 weeks (Visit 5)

  from baseline to 8 weeks

Other Outcomes (13)

• IPAQ-short, physical activity level score

  from baseline to 4 weeks, 8 weeks and 10 weeks

• Detection of Probiotic in feces

  from baseline to 8 weeks

• STAI-state

  from baseline to 4 weeks and 10 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotic

Biological: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Probiotic BIOLOGICAL

Probiotic

Probiotic

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary, written, informed consent to participate in the study
• Currently enrolled in medical, dental or health science university/institute of technology course with intention to sit semester examination(s)
• Male or female aged between 18-40 years (inclusive)
• Body mass index (BMI) between 18.5 - 29.9 Kg/m2
• Blood, urine and gastrointestinal safety parameters and blood pressure measurement at baseline indicate they are healthy in the opinion of the Principal Investigator
• In good general health as estimated by the Principal Investigator, based on medical history (self-reported)
• 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
• Ability of the participant (in the Principal Investigator's opinion) to fully comprehend and self-complete all participant reported outcomes (in UK English language)
• Participant is willing to maintain habitual diet (including caffeine and alcohol), physical activity patterns and smoking habits throughout the intervention period
• 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 be using effective contraception (e.g. surgically sterilized (tubal ligation or hysterectomy or partner is post-vasectomy, with sterility confirmed) or use an intrauterine device (IUD), a diaphragm or condom combined with contraceptive sponge, foam or jelly, or be using an oral contraceptive for at least 2 cycles before the screening visit (Visit 2). Women who are in same sex relationships or abstaining from sex are not required to take a pregnancy test or be using effective contraception
• Male participants must agree to use a condom during sexual intercourse from Visit 3 onwards
• Covered by health insurance system and / or in compliance with the recommendations of National Law in force relating to biomedical research

You may not qualify if:

• Suspected diagnosis of one or more DSM-IV axis 1 disorder(s), including but not limited to: current major depression, anxiety disorder, bipolar spectrum disorder or schizophrenia, as determined by MINI International Neuropsychiatric Interview (MINI) and/or currently diagnosed with one or more DSM-IV axis 1 disorder(s), per Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
• Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic (including diabetes and cardiovascular disease), neurodevelopmental or any condition which contraindicates, in the Principal Investigator's judgement, entry to the study
• Currently taking (from Visit 1 onwards) or have previously taken (last 4 weeks prior to Visit 1) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers)
• Currently taking (from Visit 1 onwards) medication or dietary supplements that the Principal 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, St. John's Wort, Rescue® products including Rescue Remedy®, Rescue® Energy, Rescue® Pastilles, Rescue® Pearls, Rescue Sleep® Rescue PlusTM, omega-3 dietary supplements (including fish oil), Cannabidiol (CBD), non-steroidal anti-inflammatory drugs (NSAIDS), over-the-counter sleep medication (not categorized as sedatives, hypnotics or anti-depressants), anti-coagulants, anti-cholinergic drugs or acetylcholinesterase inhibitors, proton pump inhibitors, anti-histamines that cause drowsiness, pseudoephedrine)
• Recent (within last 4 weeks prior to Visit 1) or ongoing antibiotic therapy
• Currently taking (from Visit 1 onwards) concentrated sources of probiotics and/or prebiotics other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders), including yoghurt / yoghurt drinks
• Pregnant or lactating female, or pregnancy planned during the intervention period
• Have self-reported dyslexia
• History of or current alcohol, drug, or medication abuse (self-reported)
• Self-declared illicit drug users (including cannabis and cocaine) in the past 1 month prior to Visit 1
• Excessive alcohol consumption (consuming \> 8 units of alcohol for men and \> 6 units of alcohol for women in a single session) \> 3 times per week for 3 weeks prior to Visit 1
• Significant change in tobacco, snuff, nicotine or e-cigarette usage habits in the past 1 month before Visit 1 or planned cessation of the use of these products during the intervention period
• Contraindication to any substance in the investigational product
• Participation in another study with any investigational product or drug within 60 days of Visit 1
• Principal Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Sponsors & Collaborators

• Danisco: lead
• ICON plc: collaborator
• Daacro: collaborator
• 4Pharma Ltd.: collaborator

Study Sites (7)

Atlantia Food Clinical Trials Ltd

Cork, Ireland

Location

MediNova Warwickshire Dedicated Research Centre

Kenilworth, United Kingdom

Location

MediNova North London Dedicated Research Centre

Northwood, United Kingdom

Location

MediNova Research East London Clinical Studies Centre

Romford, United Kingdom

Location

MediNova Yorkshire Dedicated Research Centre

Shipley, United Kingdom

Location

MediNova South London Dedicated Research Centre, Queen Mary's Hospital

Sidcup, United Kingdom

Location

MediNova West London Dedicated Research Centre

Wokingham, United Kingdom

Location

Related Publications (1)

• Makela SM, Griffin SM, Reimari J, Evans KC, Hibberd AA, Yeung N, Ibarra A, Junnila J, Turunen J, Beboso R, Chhokar B, Dinan TG, Cryan J, Patterson E. Efficacy and safety of Lacticaseibacillus paracasei Lpc-37(R) in students facing examination stress: A randomized, triple-blind, placebo-controlled clinical trial (the ChillEx study). Brain Behav Immun Health. 2023 Aug 1;32:100673. doi: 10.1016/j.bbih.2023.100673. eCollection 2023 Oct.

  PMID: 37662485 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Balgit Chhokar

  Medinova East London Dedicated Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: October 14, 2019
• Study Start: September 2, 2019
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); GB (6)