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

NCT02035878 | Unknown Phase 2

• 1 other identifier: POTTERHUNTER_PROBIOTICS_2013
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression

Keywords

anxiety; depression; probiotics; adult; human; depression anxiety stress scale; anxiety sensitivity index

Outcome Measures

Primary Outcomes (6)

• Depression Anxiety and Stress Scale (DASS) - Time 1 (we are assessing change over time)

  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.

  Baseline (at first meeting)

• Depression Anxiety and Stress Scale (DASS) - Time 2 (we are assessing change over time)

  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.

  administered at 10 weeks

• Depression Anxiety and Stress Scale (DASS) - Time 3 (we are assessing change over time)

  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.

  Administered at 22 weeks (i.e., the end of the study)

• Anxiety Sensitivity Index (ASI) - Time 1 (we are assessing change over time)

  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.

  Baseline (at first meeting)

• Anxiety Sensitivity Index (ASI) - Time 2 (we are assessing change over time)

  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.

  administered at 10 weeks

• Anxiety Sensitivity Index (ASI) - Time 3 (we are assessing change over time)

  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.

  administered at 22 weeks

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

400mg probiotic capsule taken once daily for ten weeks

Other: Probiotics

Placebo (rice flour)

PLACEBO COMPARATOR

400mg placebo capsule containing rice flour taken once daily for ten weeks

Drug: Placebo

Interventions

Probiotics OTHER

probiotic intervention: 400mg of probiotic capsule

Also known as: Organic Probiotics 7 Strains 20 Billion per gram

Probiotics

Placebo DRUG

placebo comparator

Also known as: 400 mg white rice flour capsules

Placebo (rice flour)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acadia University: lead

Study Sites (1)

Acadia University

Wolfville, Nova Scotia, B4P 2R6, Canada

Location

Related Publications (7)

• Dominguez-Bello MG, Costello EK, Contreras M, Magris M, Hidalgo G, Fierer N, Knight R. Delivery mode shapes the acquisition and structure of the initial microbiota across multiple body habitats in newborns. Proc Natl Acad Sci U S A. 2010 Jun 29;107(26):11971-5. doi: 10.1073/pnas.1002601107. Epub 2010 Jun 21.

  PMID: 20566857 BACKGROUND

• Harmsen HJ, Wildeboer-Veloo AC, Raangs GC, Wagendorp AA, Klijn N, Bindels JG, Welling GW. Analysis of intestinal flora development in breast-fed and formula-fed infants by using molecular identification and detection methods. J Pediatr Gastroenterol Nutr. 2000 Jan;30(1):61-7. doi: 10.1097/00005176-200001000-00019.

  PMID: 10630441 BACKGROUND

• Hooper LV, Littman DR, Macpherson AJ. Interactions between the microbiota and the immune system. Science. 2012 Jun 8;336(6086):1268-73. doi: 10.1126/science.1223490. Epub 2012 Jun 6.

  PMID: 22674334 BACKGROUND

• Forsythe P, Sudo N, Dinan T, Taylor VH, Bienenstock J. Mood and gut feelings. Brain Behav Immun. 2010 Jan;24(1):9-16. doi: 10.1016/j.bbi.2009.05.058. Epub 2009 May 28.

  PMID: 19481599 BACKGROUND

• Bienenstock J. Commensal communication to the brain: pathways and behavioral consequences. Microb Ecol Health Dis. 2012 Aug 24;23. doi: 10.3402/mehd.v23i0.19007. eCollection 2012. No abstract available.

  PMID: 23990826 BACKGROUND

• Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.

  PMID: 21876150 BACKGROUND

• Antunes LC, Han J, Ferreira RB, Lolic P, Borchers CH, Finlay BB. Effect of antibiotic treatment on the intestinal metabolome. Antimicrob Agents Chemother. 2011 Apr;55(4):1494-503. doi: 10.1128/AAC.01664-10. Epub 2011 Jan 31.

  PMID: 21282433 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dr. Susan Potter, PhD

  Acadia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 14, 2014
• Study Start: August 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

CA (1)