Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers
NCT05545813, Phase 2, Completed, Lallemand Health Solutions
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers | ClinicalTrials.gov |
| NCT number | NCT05545813 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 36 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Lallemand Health Solutions | ClinicalTrials.gov |
| Conditions | Stress, Attention Disturbances | ClinicalTrials.gov |
| Interventions | Probiotic, Placebo | ClinicalTrials.gov |
| First posted | 2022-09-19 | ClinicalTrials.gov |
| Last updated | 2023-11-29 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in reaction time | 8 weeks | The statistical difference in change in reaction time (in milliseconds) from baseline during a computerized task-switching color-word Stroop task following acute stress between the probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Change in reaction time: acute stress condition | 8 weeks | The statistical difference in changes in reaction time (in milliseconds) on a computerized incongruent CWST between probiotic and placebo groups following acute stress. | ClinicalTrials.gov |
| Secondary | Change in accuracy: acute stress condition | 8 weeks | The statistical difference in changes in accuracy (proportion correct) on a computerized task-switching CWST and incongruent CWST between probiotic and placebo groups following acute stress. | ClinicalTrials.gov |
| Secondary | Change in reaction time: non-stressful condition | 8 weeks | The statistical difference in changes in reaction time (in milliseconds) on a computerized task-switching and incongruent CWST and a visual search (VS) paradigm, between probiotic and placebo groups in a non-stressful condition. | ClinicalTrials.gov |
| Secondary | Change in accuracy: non-stressful condition | 8 weeks | The statistical difference in changes in accuracy (proportion correct; %false alarms) on a computerized task-switching and an incongruent CWST, a go/no-go paradigm, a visual working memory maintenance paradigm, and a visual working memory complex span task (SYMSPAN) between probiotic and placebo groups in a non-stressful condition. | ClinicalTrials.gov |
| Secondary | Change in self-reported cognitive control: non-stressful condition | 8 weeks | The statistical difference in changes in self-reported cognitive control and cognitive flexibility as per the Cognitive Control and Flexibility Questionnaire (CCFQ) between probiotic and placebo groups in a non-stressful condition. | ClinicalTrials.gov |
| Secondary | Changes in oxyhemoglobin concentrations in pre-frontal cortex | 8 weeks | The statistical difference in changes in concentrations of oxygenated hemoglobin in the prefrontal cortex (PFC) during the task-switching CWST from baseline between the probiotic and placebo groups following acute stress and under non-stress conditions. | ClinicalTrials.gov |
| Secondary | Changes in cortisol | 8 weeks | The statistical difference in changes in the cortisol response to acute stress from baseline, as measured by the area under the curve with respect to increase (AUCi) and with respect to ground (AUCg) between probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in salivary DHEA-S | 8 weeks | The statistical difference in salivary DHEA-S from baseline between the probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in salivary cortisol/DHEA-S ratio | 8 weeks | The statistical difference in the salivary cortisol/DHEA-S ratio from baseline between the probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in immune activity markers | 8 weeks | The statistical difference in changes in salivary levels of proinflammatory cytokines, interleukin-1 beta, and interleukin-6 from baseline between probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in self-reported levels of depression symptomology | 8 weeks | The statistical difference in changes in the depression subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) from baseline between the probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in self-reported levels of anxiety symptomology | 8 weeks | The statistical difference in changes in the anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) from baseline between the probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in self-reported levels of perceived stress symptomology | 8 weeks | The statistical difference in changes in the stress subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) from baseline between the probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in self-reported levels of anxiety, depression, and perceived stress symptomology | 8 weeks | The statistical difference in changes in the total scale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) between the probiotic and placebo groups. | ClinicalTrials.gov |
| Secondary | Changes in self-reported sleep quality | 8 weeks | The statistical differences in changes in total Pittsburgh Sleep Quality Index (PSQI) scores between the probiotic and placebo groups. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)