Working… Menu
Trial record 1 of 1 for:    Probiotic treatment in adult obsessive-compulsive disorder:
Previous Study | Return to List | Next Study

Probiotic Treatment in Adult Obsessive-Compulsive Disorder

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02334644
Recruitment Status : Recruiting
First Posted : January 8, 2015
Last Update Posted : September 2, 2020
Hamilton Health Sciences Corporation
Lallemand Health Solutions
Information provided by (Responsible Party):
McMaster University

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

Show Show detailed description

Layout table for study information
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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

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
Dietary Supplement: Placebo
2 sachets/day x 12 weeks

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 ]

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  4. Current use of any psychotropic agent is permitted given that that individual has been on a stable dose for at least 8 weeks.

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 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.
  5. 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.
  6. 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.
  7. Patients meeting criteria for current substance use disorder.
  8. Antibiotic or probiotic use within 8 weeks of entering the study and stool sampling.
  9. Reports frequent consumption of foods rich in/enriched with probiotics (yogurt etc).
  10. Individuals with immune-compromised conditions (i.e. AIDS, lymphoma) or those undergoing long-term corticosteroid treatment.
  11. Individuals with a soy or lactose allergy.
  12. Female participants must not be breastfeeding, pregnant or seeking to get pregnant during the course of this study.
  13. History of allergic response to probiotics or any other related drugs.
  14. Currently physically unwell including experiencing nausea, fever, vomiting, abdominal pain, bloody diarrhea.
  15. Individuals with prosthetic heart valves, or a history of valvular heart disease.

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 identifier (NCT number): NCT02334644

Layout table for location contacts
Contact: Beth Patterson, BScN, BEd 9059217644
Contact: Jasmine Turna, BSc 9059217644

Layout table for location information
Canada, Ontario
MacAnxiety Research Centre Recruiting
Hamilton, Ontario, Canada, L8S 1B7
Contact: Beth Patterson, BScN, BEd    905-921-7644   
Contact: Jasmine Turna, BSc    905-921-7644   
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Lallemand Health Solutions
Layout table for investigator information
Principal Investigator: Michael Van Ameringen, MD, FRCPC McMaster University
Layout table for additonal information
Responsible Party: McMaster University Identifier: NCT02334644    
Other Study ID Numbers: 15-049
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Natural Health Product
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders