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

Phase 2 Completed 190 enrolled Danisco 4Pharma Ltd. · collab Daacro · collab ICON plc · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2019-09-02
Primary completion: 2020-02-07
Completion: 2020-02-07

Outcome

Missed primary endpoint

paper There was no difference between Lpc-37 and placebo groups in the change of STAI-state score (estimate 1.03; 95% confidence interval [CI]: -1.62, 3.67; p = 0.446). PMID 37662485 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lacticaseibacillus paracasei Lpc-37	Other / unclassified	1.56e+10 unknown	—

Indications

No indication recorded.