CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 128 target
Drug / intervention
ProbioStick +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02417454
NCT02417454Phase 3Completed

A Double Blind Placebo Controlled Study on the Effects of a Probiotic on Autonomic and Psychological Stress Responses in Volunteers

McMaster University·interventional·Posted Apr 15, 2015·Updated Oct 19, 2017

In Brief

A Phase 3 clinical trial evaluating ProbioStick and Placebo for Stress, Psychological. Completed, enrolled 128 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the effects of a probiotic blend on qualitative (subjective interviews and self-reporting) and quantitative (changes in brain activity, heart rate, cortisol, and reactivity) measures of stress in healthy undergraduate students.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 15, 2015
Enrollment StartSep 1, 2015
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.2 years ago

Interventions

ProbioStickdietary

One sachet daily, without or without meals (3 x 10\^9 CFU per sachet) (Lactobacillus helveticus R0052 and Bifidobacterium longum subsp. longum R0175)

Placeboother

One sachet daily, without or without meals (0 CFU per sachet)