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Probiotic

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment190

FDA Designations

No designations recorded

Clinical trial landscape

Probiotic · 1 trial · 2 indications

Phase 2 1
NCT04125810A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological StressStress, Psychological
COMPLETED190 Analytics
PHASE2COMPLETED
A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress
Stress, Psychological
NCT04125810190
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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 to 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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Frequently asked questions about Probiotic

What is Probiotic used for?

Probiotic is an investigational monoclonal antibody being studied for its potential to modulate psychological stress. It is being evaluated in healthy volunteers as a treatment for stress and psychological conditions. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Probiotic?

Probiotic is being developed by Icon Plc, a company listed on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical trials to assess the safety and efficacy of Probiotic for psychological stress.

What phase is Probiotic in?

Probiotic is in Phase 2 clinical development. A Phase 2 trial has been completed to evaluate its safety and efficacy in modulating psychological stress. The drug is investigational and has not received regulatory approval.

What clinical trials is Probiotic in?

Probiotic has been studied in a Phase 2 clinical trial registered as NCT04125810, titled "A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress." The trial enrolled 190 participants in Ireland and the United Kingdom and has been completed.

Is Probiotic the same as a dietary supplement?

No, Probiotic is not a dietary supplement. It is a monoclonal antibody, a type of biologic drug, being investigated for its effects on psychological stress. Despite its name, it is distinct from probiotic supplements commonly used for gut health.