Probiotic for Stress

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cognitive and Motor Performance Lab, Dalplex, Kinesiology Suites, Dalhousie University (Rm. 213), Halifax, CanadaStress+1 MoreProbiotic - DietarySupplement
Eligibility
19 - 35
All Sexes
What conditions do you have?
Select

Study Summary

This trial is investigating whether probiotics can help people perform better on a task after experiencing stress.

Eligible Conditions
  • Stress
  • Attention Deficit Disorder (ADD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Subjects receiving Probiotic Dietary Supplement
1
Self-monitoring and personalized stress management
1
Personalized Trial ABCCBA

Study Objectives

1 Primary · 15 Secondary · Reporting Duration: 8 weeks

8 weeks
Change in accuracy: acute stress condition
Change in accuracy: non-stressful condition
Change in reaction time
Change in reaction time: acute stress condition
Change in reaction time: non-stressful condition
Change in self-reported cognitive control: non-stressful condition
Changes in cortisol
Changes in immune activity markers
Changes in oxyhemoglobin concentrations in pre-frontal cortex
Changes in salivary DHEA-S
Body Weight Changes
Changes in self-reported levels of anxiety symptomology
Changes in self-reported levels of anxiety, depression, and perceived stress symptomology
Mental Depression
Changes in self-reported levels of perceived stress symptomology
Changes in self-reported sleep quality

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Subjects receiving Probiotic Dietary Supplement
2
Self-monitoring and personalized stress management
2
Personalized Trial ABCCBA

Trial Design

2 Treatment Groups

Probiotic
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

36 Total Participants · 2 Treatment Groups

Primary Treatment: Probiotic · Has Placebo Group · Phase 2

Probiotic
DietarySupplement
Experimental Group · 1 Intervention: Probiotic · Intervention Types: DietarySupplement
Placebo
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

Lallemand Health SolutionsLead Sponsor
35 Previous Clinical Trials
3,433 Total Patients Enrolled
Dalhousie UniversityOTHER
155 Previous Clinical Trials
340,141 Total Patients Enrolled
Heather Neyedli, Ph.D.Principal InvestigatorDalhousie University
Tara Perrot, Ph.D.Principal InvestigatorDalhousie University

Eligibility Criteria

Age 19 - 35 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to stop taking probiotic supplements, probiotic-fortified products, and fiber supplements (like Metamucil, Benefiber) during the study.
You are willing and able to take a probiotic or a sugar pill for 8 weeks.
You must be willing to keep playing video games for the whole study period.
You agree to keep your regular eating habits during the study.
You agree to keep the same level of physical activity during the study.
You have played games that involve shooting or action for at least 5 hours per week in the last year, as reported by yourself.
References

Frequently Asked Questions

Who has the opportunity to take part in this medical research?

"This research is seeking to enlist 36 participants, aged 19-35, who have experienced stress. Eligibility criteria necessitates that individuals must be of both genders and able to give informed consent. Moreover, potential subjects should have spent at least 5 hours per week for the prior year playing action video games such as first- and third-person shooters or roleplaying titles; willingness to continue this level of gaming during the trial period is also required. Furthermore, applicants must commit to maintaining their current diet regimen throughout the study and abstaining from probiotic supplements and fiber products like Metamucil or Benefiber while participating in it. Additionally," - Anonymous Online Contributor

Unverified Answer

Are there currently any opportunities for participants to join this experiment?

"According to the information on clinicaltrials.gov, this particular medical trial is not currently open for participant recruitment. Initially posted in October 1st 2022 and last updated on September 15th 2022, unfortunately there are no available spots at present; however, 144 other studies remain actively recruiting patients." - Anonymous Online Contributor

Unverified Answer

Is the age limit of 85+ years imposed on participants for this research endeavor?

"As per the study's requirements, prospective participants must possess a minimum age of 19 and an upper boundary of 35." - Anonymous Online Contributor

Unverified Answer

Does the FDA certify Probiotic as a safe and effective product?

"Probiotic's safety has been partially validated, granting it a score of 2. However, no clinical data is currently available to assess its efficacy in this Phase 2 trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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