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Probiotics and the Microbiome: Clinical Intervention Trial for Anxiety and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035878
Recruitment Status : Unknown
Verified January 2014 by Acadia University.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Acadia University

Brief Summary:
The proposed project will investigate the effects of probiotics on anxiety and associated psychological and physiological factors in humans. The therapeutic potential of probiotics for reducing anxiety and other factors associated with a disrupted microbiome will be assessed in a double-blind placebo-crossover design. Based on the research findings to date, it is hypothesized that probiotics will reduce anxiety and depressive symptoms.

Condition or disease Intervention/treatment Phase
Anxiety Depression Other: Probiotics Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics and the Microbiome: Clinical Intervention Trial for Anxiety and Depression
Study Start Date : August 2012
Actual Primary Completion Date : October 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Probiotics
400mg probiotic capsule taken once daily for ten weeks
Other: Probiotics
probiotic intervention: 400mg of probiotic capsule
Other Name: Organic Probiotics 7 Strains 20 Billion per gram

Placebo Comparator: Placebo (rice flour)
400mg placebo capsule containing rice flour taken once daily for ten weeks
Drug: Placebo
placebo comparator
Other Name: 400 mg white rice flour capsules




Primary Outcome Measures :
  1. Depression Anxiety and Stress Scale (DASS) - Time 1 (we are assessing change over time) [ Time Frame: Baseline (at first meeting) ]
    A self-report questionnaire that assesses current symptoms of depression, anxiety, and feelings related to stress. Note that this measure is completed by participants at three different time points in order to assess change in symptoms across time points.

  2. Depression Anxiety and Stress Scale (DASS) - Time 2 (we are assessing change over time) [ Time Frame: administered at 10 weeks ]
    A self-report questionnaire that assesses current symptoms of depression, anxiety, and feelings related to stress. Note that this measure is completed by participants at three different time points in order to assess change in symptoms across time points.

  3. Depression Anxiety and Stress Scale (DASS) - Time 3 (we are assessing change over time) [ Time Frame: Administered at 22 weeks (i.e., the end of the study) ]
    A self-report questionnaire that assesses current symptoms of depression, anxiety, and feelings related to stress. Note that this measure is completed by participants at three different time points in order to assess change in symptoms across time points.

  4. Anxiety Sensitivity Index (ASI) - Time 1 (we are assessing change over time) [ Time Frame: Baseline (at first meeting) ]
    A self-report questionnaire that assesses anxiety sensitivity -- the degree to which an individual focuses on and notices (and avoids) physical changes related to anxiety. Note that this measure is completed by participants at three different time points in order to assess change in anxiety sensitivity across time points.

  5. Anxiety Sensitivity Index (ASI) - Time 2 (we are assessing change over time) [ Time Frame: administered at 10 weeks ]
    A self-report questionnaire that assesses anxiety sensitivity -- the degree to which an individual focuses on and notices (and avoids) physical changes related to anxiety. Note that this measure is completed by participants at three different time points in order to assess change in anxiety sensitivity across time points.

  6. Anxiety Sensitivity Index (ASI) - Time 3 (we are assessing change over time) [ Time Frame: administered at 22 weeks ]
    A self-report questionnaire that assesses anxiety sensitivity -- the degree to which an individual focuses on and notices (and avoids) physical changes related to anxiety. Note that this measure is completed by participants at three different time points in order to assess change in anxiety sensitivity across time points.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • I have a valid email address that I check routinely and daily access to the internet.
  • I experience symptoms of anxiety and/or depression.
  • I am over the age of 18.
  • I am within driving distance of Wolfville, Kingston-Greenwood, or Halifax, Nova Scotia, and would be able to come to Wolfville or Halifax for appointments with the researchers. OR I am not within driving distance of Wolfville, Nova Scotia or Halifax Nova Scotia, but am a resident of Canada and would be available for telephone or online conference calls.

Exclusion Criteria:

  • I am a University/College professor or student.
  • I have one or more of the following diagnosed conditions: Cancer, Crohn's disease or ulcerative colitis, Multiple sclerosis, Lupus, Addison's Disease or other form of adrenal insufficiency
  • I am currently taking antibiotics or probiotic capsules.*
  • I have diagnosed HIV/AIDS.
  • I am currently undergoing chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035878


Locations
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Canada, Nova Scotia
Acadia University
Wolfville, Nova Scotia, Canada, B4P 2R6
Sponsors and Collaborators
Acadia University
Investigators
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Principal Investigator: Dr. Susan Potter, PhD Acadia University
Publications:

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Responsible Party: Acadia University
ClinicalTrials.gov Identifier: NCT02035878    
Other Study ID Numbers: POTTERHUNTER_PROBIOTICS_2013
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Acadia University:
anxiety
depression
probiotics
adult
human
depression anxiety stress scale
anxiety sensitivity index
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders