Probiotic Administration on Mood
Condition: Depression; Sleep; Stress; Anxiety; Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

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.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): After baseline or initial testing, participants will be randomly assigned in a double-blind fashion to ingest on a daily basis for 6 weeks either a placebo or a probiotic supplement. Identical follow-up measurements will then occur each visit after taking their assigned supplement. After 6 weeks of administration, the supplementation protocol will stop and a final evaluation will be completed 3 weeks later (9 weeks after initial administration) to assess any residual impact of the assigned supplement after a 3-week washout.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: andomized, double-blind, placebo-controlled, parallel study design that will evaluate the ability of a probiotic to influence mood, depressive symptoms, anxiety, sleep quality, and other personality traits in a group of healthy men and women
Masking: Double (Participant, Investigator)
Primary purpose: Other