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Microbiome in Obsessive-compulsive Disorder (MIO)

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ClinicalTrials.gov Identifier: NCT03638791
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Christian Rück, Karolinska Institutet

Brief Summary:

Background: Humans live in symbiosis with microbes and their implication for health and disease is evident. The importance of microbiome-gut-brain axis in psychiatric disorders is an area of increasing research interest. OCD is a promising target for microbiome research as Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)/ Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are reactions to infectious agents precipitating acute onset of severe OCD symptoms. Furthermore, preliminary evidence has associated probiotic treatment with alleviation of OCD symptoms. We propose the first clinical study on the microbiome and its effects on OCD patients.

Aim: To analyze the skin and intestinal microbiota in OCD patients with fear of contamination compared to healthy matched controls and assess changes in microbial composition following treatment.

Outcome measures: Differences in alpha diversity (number of observed species and Chao-1 estimator), beta diversity (UniFrac distances), and taxa abundance of bacterial groups (at the phylum, class, order, family, and genus levels) and severity of OCD symptoms.

Methods: Our aim is to enroll 30 OCD patients, 30 OCD patients with washing compulsion and 30 matched controls. 16S rRNA sequencing will be used. Sequenced data will be processed followed by non-parametric statistical testing.

Significance: Skin and gut microbiome has never been studied in OCD patients before. The microbial composition may impact on OCD symptoms, severity, and chronicity and could inform future therapeutic possibilities.


Condition or disease Intervention/treatment
Obsessive-Compulsive Disorder Microbiota Behavioral: Exposure and response inhibition

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Skin and Gut Microbiome Impact on Obsessive Compulsive Disorder (OCD) Symptoms and Treatment Effect
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy controls
Matched Controls without treatment
OCD with washing compulsion
Exposure and response inhibition
Behavioral: Exposure and response inhibition
Cognitive behavioural therapy designed for treatment of Obsessive-compulsive disorder

OCD without washing compulsion
Exposure and response inhibition
Behavioral: Exposure and response inhibition
Cognitive behavioural therapy designed for treatment of Obsessive-compulsive disorder




Primary Outcome Measures :
  1. Alpha diversity [ Time Frame: 2018-09-01 ]
    expressed as number of observed species and Chao-1 estimator


Secondary Outcome Measures :
  1. Beta diversity [ Time Frame: 2018-09-01 ]
    UniFrac distances

  2. Correlation between microbiota diversity and symptom severity [ Time Frame: 2018-09-01 ]
    correlation between alpha diversity and Y-BOCS score

  3. Change in microtioba diversity before and after ERP treatment [ Time Frame: 2018-09-01 ]
    Change in alpha diversity before and after treatment


Biospecimen Retention:   Samples With DNA
Faeces and skin


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Recruitment of participants from Karolinska Hospital in Solna and Huddinge. Healthy Controls are recruited from Sweden from advertisements.
Criteria

Inclusion Criteria:

  • DSM-5 diagnosis of OCD. Age matched controls will be recruited who have no personal or family history of OCD.

Exclusion Criteria:

  • history of GI tract surgery (other than appendectomy or cholecystectomy); history of inflammatory bowel disease, irritable bowel syndrome, celiac disease, or any other diagnosis that could explain chronic or recurring bowel symptoms, antibiotic use in the past 3 months; pro-biotic use in the past 4 weeks; pregnancy. Intellectual disability, autism spectrum disorder and psychosis.

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 ClinicalTrials.gov identifier (NCT number): NCT03638791


Contacts
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Contact: Long Chen, MD +46725670088 long.chen@ki.se

Locations
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Sweden
M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Recruiting
Stockholm, Huddinge, Sweden, 141 86
Contact: Christian Rück, M.D., Ph.D    +46(0)70484 33 92    christian.ruck@ki.se   
Principal Investigator: Christian Rück, M.D., Ph.D.         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Chair: Christian Rück, MD Karolinska Institutet
Principal Investigator: Diana Radu Djurfeldt, MD Karolinska Institutet

Additional Information:

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Responsible Party: Christian Rück, Head of Rucklab, affiliate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03638791     History of Changes
Other Study ID Numbers: Microbiome in OCD
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders