Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05343533
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2022-03-29
Brief Title:
Probiotic Administration on Mood
Sponsor:
Lindenwood University
Organization:
Lindenwood University
Study Overview
Official Title:
Impact of Probiotic Administration on Mood Psychological Traits Physical Activity Stress and Sleep Quality
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAM
Brief Summary:
Researchers are looking to examine the impact of probiotic administration on symptoms commonly associated with depression anxiety stress sleep quality and associated emotional responses in healthy men and women
Detailed Description:
In recent years the presence and awareness of a connection between the intestines and the brain has expanded leading to the understanding of developed communication pathways between the nervous endocrine and immune systems Intestinal bacterial flora are active contributors to this axis through cellular signaling pathways and the release of immune system components which fundamentally impact the function and action of various physiological systems Interest in this area evolved through the understanding that various microbiota can produce neuroactive substances and neurotransmitters involved with the endocrine and autonomic nervous system pathways This research has expanded to state that various bacterial products can influence cognitive functions involving types of memory and problem-solving Recent findings have begun to report on the impact that probiotic administration may have on mood anxiety and depression Finally recent work by Marotta et al provided some of the first preliminary evidence that probiotic use may also impact mood and sleep quality While initial work has developed this foundation very little controlled research is available to help understand key contributing factors For example many key questions remain that future research should address to help better understand any impact probiotics may have on mood depression and anxiety Some of these questions include
Do all forms genus strain etc of probiotics exert these impacts How quickly do they exert impact How large is the impact Are certain aspect of affect more impacted than others Once supplemented how long is the residual impact if there is any To help provided more guidance towards some of these basic research questions this study is being proposed The purpose of the study is to expand upon the previous work of Marotta et al and determine the impact of probiotic administration on mood depressive symptoms anxiety sleep quality and other personality traits in a larger group of healthy men and women This study will expand on the supplementation regimen and include a wider variety of hormonal assessments than what has previously been completed using this combination of probiotics
Do all forms genus strain etc of probiotics exert these impacts How quickly do they exert impact How large is the impact Are certain aspect of affect more impacted than others Once supplemented how long is the residual impact if there is any To help provided more guidance towards some of these basic research questions this study is being proposed The purpose of the study is to expand upon the previous work of Marotta et al and determine the impact of probiotic administration on mood depressive symptoms anxiety sleep quality and other personality traits in a larger group of healthy men and women This study will expand on the supplementation regimen and include a wider variety of hormonal assessments than what has previously been completed using this combination of probiotics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None