Trial record 2 of 21 for:    ACADIA

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acadia University
ClinicalTrials.gov Identifier:
NCT02035878
First received: January 8, 2014
Last updated: January 11, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Anxiety
Depression
Other: Probiotics
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics and the Microbiome: Clinical Intervention Trial for Anxiety and Depression

Resource links provided by NLM:


Further study details as provided by Acadia University:

Primary Outcome Measures:
  • Depression Anxiety and Stress Scale (DASS) - Time 1 (we are assessing change over time) [ Time Frame: Baseline (at first meeting) ] [ Designated as safety issue: No ]
    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.

  • Depression Anxiety and Stress Scale (DASS) - Time 2 (we are assessing change over time) [ Time Frame: administered at 10 weeks ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Anxiety Sensitivity Index (ASI) - Time 1 (we are assessing change over time) [ Time Frame: Baseline (at first meeting) ] [ Designated as safety issue: No ]
    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.

  • Anxiety Sensitivity Index (ASI) - Time 2 (we are assessing change over time) [ Time Frame: administered at 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Anxiety Sensitivity Index (ASI) - Time 3 (we are assessing change over time) [ Time Frame: administered at 22 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: August 2012
Estimated Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035878

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

Additional Information:
Publications:

Responsible Party: Acadia University
ClinicalTrials.gov Identifier: NCT02035878     History of Changes
Other Study ID Numbers: POTTERHUNTER_PROBIOTICS_2013
Study First Received: January 8, 2014
Last Updated: January 11, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Acadia University:
anxiety
depression
probiotics
adult
human
depression anxiety stress scale
anxiety sensitivity index

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on September 16, 2014