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Probiotic Treatment in Adult Obsessive-Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT02334644
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Lallemand Health Solutions
Information provided by (Responsible Party):
McMaster University

Study Description
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Brief Summary:
This study will evaluate the effectiveness of 12-weeks of probiotic treatment in adults with primary Obsessive-Compulsive Disorder and whether this treatment will alter the microbiota composition in these patients.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Dietary Supplement: Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) Dietary Supplement: Placebo Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-week Randomized Controlled Trial of Probiotic Treatment (Lactobacillus Helveticus R0052 and Bifidobacterium Longum R0175) vs Placebo in Adult Obsessive Compulsive Disorder
Study Start Date : April 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)
 Dietary Supplement: Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)
2 sachets/day x 12 weeks
Placebo Comparator: 2
Placebo
 Dietary Supplement: Placebo
2 sachets/day x 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Yale Brown Obsessive-Compulsive Scale [YBOCS] [ Time Frame: 12 weeks ]
  2. Clinical Global Impression - Improvement ≤ 2 [CGI-I] [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire [ Time Frame: 12 weeks ]
  2. Sheehan Disability Scale [ Time Frame: 12 weeks ]
  3. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ]
  4. Obsessive-Compulsive Inventory - Revised [ Time Frame: 12 weeks ]
  5. Depression Anxiety Stress Scale [ Time Frame: 12 weeks ]
  6. Dutch Dimensional Obsessive-Compulsive Scale [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a principal diagnosis of OCD (DSM 5) according to the MINI with a Y-BOCS score of ≥20
  2. The ability to comprehend and satisfactorily comply with protocol requirements
  3. Written informed consent given prior to beginning of the study.

Exclusion Criteria:

  1. Participants with current Major Depressive Disorder
  2. A MADRS score ≥ 18. Patients with significant suicidal ideation (MADRS item 10 ≥ 3) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention
  3. Individuals with current autoimmune disorders (rheumatoid arthiritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes
  4. Current use of any psychotropic agent including: SSRIs, benzodiazepines, MAO Inhibitors, tricyclic antidepressants. Past pharmacotherapy is permitted if treatment ended 3 months prior to entering the study and stool sampling
  5. Current use of herbal psychoactive treatments i.e. St. John's Wort, Kava Kava, Chamomile Extract, Valeria. Past use is permitted if treatment ended 3 months prior to entering the study and stool sampling
  6. Participants receiving current psychotherapy, including cognitive behavioural therapy for an anxiety or mood disorder. Past psychotherapy is permitted if treatment ended 3 months prior to entering the study and stool sampling
  7. Patients who currently fulfill criteria for a lifetime history of bipolar disorder, history of drug abuse, a history of schizophrenia or other psychotic disorders, delirium, dementia and amnesic and other cognitive disorders, or are in a current agitated state
  8. Patients meeting criteria for current substance use disorder
  9. A body mass index (BMI) >30
  10. Antibiotic or probiotic use within 8 weeks of entering the study and stool sampling
  11. Reports frequent consumption of foods rich in/enriched with probiotics (yogurt etc)
  12. Individuals with immune-compromised conditions (i.e. AIDS, lymphoma) or those undergoing long-term corticosteroid treatment
  13. Individuals with a soy or lactose allergy
  14. Female participants must not be breastfeeding, pregnant or seeking to get pregnant during the course of this study
  15. History of allergic response to probiotics or any other related drugs
  16. Currently physically unwell including experiencing nausea, fever, vomiting, abdominal pain, bloody diarrhea
Contacts and Locations
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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): NCT02334644


Contacts
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Contact: Beth Patterson, BScN, BEd 9059217644 bpatter@mcmaster.ca
Contact: Jasmine Turna, BSc 9059217644 jasmine@macanxiety.com

Locations
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Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson, BScN, BEd    905-921-7644    bpatter@mcmaster.ca   
Contact: Jasmine Turna, BSc    905-921-7644    jasmine@macanxiety.com   
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Lallemand Health Solutions
Investigators
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Principal Investigator: Michael Van Ameringen, MD, FRCPC McMaster University
More Information
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02334644     History of Changes
Other Study ID Numbers: 15-049
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: March 2018

Keywords provided by McMaster University:
Treatment
Natural Health Product
Anxiety

Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Pathologic Processes
 Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents