Probiotic Treatment in Adult Obsessive-Compulsive Disorder
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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: NCT02334644 |
Recruitment Status :
Terminated
(drug expired)
First Posted : January 8, 2015
Last Update Posted : September 10, 2021
|
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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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 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 |
Actual Primary Completion Date : | April 30, 2021 |
Actual Study Completion Date : | April 30, 2021 |

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 |
- Yale Brown Obsessive-Compulsive Scale [YBOCS] [ Time Frame: 12 weeks ]
- Clinical Global Impression - Improvement ≤ 2 [CGI-I] [ Time Frame: 12 weeks ]
- Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire [ Time Frame: 12 weeks ]
- Sheehan Disability Scale [ Time Frame: 12 weeks ]
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ]
- Obsessive-Compulsive Inventory - Revised [ Time Frame: 12 weeks ]
- Depression Anxiety Stress Scale [ Time Frame: 12 weeks ]
- Dutch Dimensional Obsessive-Compulsive Scale [ Time Frame: 12 weeks ]

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.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a principal diagnosis of OCD (DSM 5) according to the MINI with a Y-BOCS score of ≥20
- The ability to comprehend and satisfactorily comply with protocol requirements
- Written informed consent given prior to beginning of the study.
- 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:
- Participants with current Major Depressive Disorder.
- 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.
- Individuals with current autoimmune disorders (rheumatoid arthiritis, systemic lupus erythematosus, multiple sclerosis, etc.), inflammatory bowel disease, diabetes.
- 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.
- 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.
- 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.
- Patients meeting criteria for current substance use disorder.
- Antibiotic or probiotic use within 8 weeks of entering the study and stool sampling.
- Reports frequent consumption of foods rich in/enriched with probiotics (yogurt etc).
- Individuals with immune-compromised conditions (i.e. AIDS, lymphoma) or those undergoing long-term corticosteroid treatment.
- Individuals with a soy or lactose allergy.
- Female participants must not be breastfeeding, pregnant or seeking to get pregnant during the course of this study.
- History of allergic response to probiotics or any other related drugs.
- Currently physically unwell including experiencing nausea, fever, vomiting, abdominal pain, bloody diarrhea.
- Individuals with prosthetic heart valves, or a history of valvular heart disease.

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
Canada, Ontario | |
MacAnxiety Research Centre | |
Hamilton, Ontario, Canada, L8S 1B7 |
Principal Investigator: | Michael Van Ameringen, MD, FRCPC | McMaster University |
Responsible Party: | McMaster University |
ClinicalTrials.gov Identifier: | NCT02334644 |
Other Study ID Numbers: |
15-049 |
First Posted: | January 8, 2015 Key Record Dates |
Last Update Posted: | September 10, 2021 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Treatment Natural Health Product Anxiety |
Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders |