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Probiotic

Phase 2

Stress, Psychological | Monoclonal antibody | Other |Icon Plc|Last Updated: Mar 25, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04125810A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological StressPHASE2 COMPLETED 190 — — Sep 2, 2019Feb 7, 2020Mar 25, 20207 Ireland, United Kingdom
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Study Endpoints
Primary Endpoints
State Trait Anxiety Inventory (STAI)-state total score
from baseline to 8 weeks

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

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ProbioticEXPERIMENTALProbiotic
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
ProbioticBIOLOGICALProbiotic
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: 1. Voluntary, written, informed consent to participate in the study 2. Currently enrolled in medical, dental or health science university/institute of technology course with intention to sit semester examination(s) 3. Male or female aged between 18-40 years (inclusive) 4. Body m...

Countries:IrelandUnited Kingdom
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