NCT02334644

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
3.6 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

January 6, 2015

Last Update Submit

September 9, 2021

Conditions

Obsessive-Compulsive Disorder

Keywords

TreatmentNatural Health ProductAnxiety

Outcome Measures

Primary Outcomes (2)

  • Yale Brown Obsessive-Compulsive Scale [YBOCS]

    12 weeks

  • Clinical Global Impression - Improvement ≤ 2 [CGI-I]

    12 weeks

Secondary Outcomes (6)

  • Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire

    12 weeks

  • Sheehan Disability Scale

    12 weeks

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    12 weeks

  • Obsessive-Compulsive Inventory - Revised

    12 weeks

  • Depression Anxiety Stress Scale

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)

Dietary Supplement: Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)

2

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)DIETARY_SUPPLEMENT

2 sachets/day x 12 weeks

1
PlaceboDIETARY_SUPPLEMENT

2 sachets/day x 12 weeks

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MacAnxiety Research Centre

Hamilton, Ontario, L8S 1B7, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Michael Van Ameringen, MD, FRCPC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

September 1, 2018

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

CA(1)