Microbiome in Obsessive-compulsive Disorder

NCT03638791 | Completed

• 1 other identifier: Microbiome in OCD
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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 gut microbiota in patients with OCD compared with healthy matched controls and assess changes in microbial composition following treatment. Outcome measures: Differences in alpha diversity, beta diversity, and taxa abundance of bacterial groups (at the phylum, class, order, family, genus and species levels) and severity of OCD symptoms. Moreover, functional profiling will be conducted. Methods: Our aim is to enroll 32 OCD patients and 32 matched controls. Shotgun metagenomic sequencing will be used. Sequenced data will be processed followed by non-parametric statistical testing. Significance: gut microbiome in patients with OCD beofre and after ERP treatment has never been done before. The microbial composition may impact on OCD symptoms, severity, and chronicity and could inform future therapeutic possibilities.

Conditions

Obsessive-Compulsive Disorder; Microbiota

Outcome Measures

Primary Outcomes (1)

• Alpha diversity

  expressed as number of observed species and Chao-1 estimator

  2018-09-01

Secondary Outcomes (3)

• Beta diversity

  2018-09-01

• Taxonomic and functional differences between cases and controls

  2018-09-01

• Change in microtioba diversity before and after ERP treatment

  2018-09-01

Study Arms (2)

Healthy controls

Matched Controls without treatment

Behavioral: Exposure and response inhibition

OCD

Exposure and response inhibition

Behavioral: Exposure and response inhibition

Interventions

Exposure and response inhibition BEHAVIORAL

Cognitive behavioural therapy designed for treatment of Obsessive-compulsive disorder

Healthy controls; OCD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Recruitment of participants from Karolinska Hospital in Solna and Huddinge. Healthy Controls are recruited from Sweden from advertisements.

You may qualify if:

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

You may not qualify if:

• 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 psychotic disorders.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst

Stockholm, Huddinge, 141 86, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Christian Rück, MD

  Karolinska Institutet

  STUDY CHAIR

• Diana Radu Djurfeldt, MD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rucklab, affiliate professor

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: December 5, 2018
• Primary Completion: September 4, 2022
• Study Completion: September 4, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

SE (1)