Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000718347
Ethics application status
Approved
Date submitted
3/03/2017
Date registered
17/05/2017
Date last updated
12/08/2019
Date data sharing statement initially provided
2/08/2019
Date results information initially provided
2/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Early life exposure to antibiotics and mental health disorders later in life
Scientific title
Early life exposure to antibiotics and mental health disorders in childhood and adolescence
Secondary ID [1] 291344 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Mood disorders 302327 0
Anxiety disorders 302770 0
Autism spectrum disorders 302771 0
Attention Deficit hyperactivity disorder 302772 0
developmental disorders 313893 0
psychotic disorders 313894 0
Schizophrenia 313895 0
Suicidal attempt 313896 0
conduct disorders 313897 0
substance use disorders 313898 0
Condition category
Condition code
Mental Health 301911 301911 0 0
Depression
Mental Health 302284 302284 0 0
Autistic spectrum disorders
Mental Health 312310 312310 0 0
Psychosis and personality disorders
Mental Health 312311 312311 0 0
Suicide
Mental Health 312312 312312 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
16
Target follow-up type
Years
Description of intervention(s) / exposure
Within a retrospective cohort design, exposure to antibiotics during pregnancy and the first 3 years of life were evaluated with respect to the frequency of exposure, gestational and postnatal age at exposure, antibiotic class, and type. The participants have already been followed up for a maximum of 16 years from the third birth date. Data will be collected from medical records, hospital discharge abstracts and drug information network.

All these changes were made before the enrollment commencement but was not updated here
Intervention code [1] 297371 0
Not applicable
Comparator / control treatment
The control group consists of all children who have not been exposed to any antibiotics during fetal period and after birth.

The sources of data for this cohort study will come from the Manitoba Population Research Data Repository which is a comprehensive collection of data related to patterns of heath care and profiles of heath and illness for Manitoba residents. We focus on data collected from April1, 1995 to May 31, 2014.
Data on primary outcome measures from birth between January 1995 and December 2014 will be included in the analyses.
Control group
Historical

Outcomes
Primary outcome [1] 301342 0
Mood and anxiety disorders were assessed after the third birth date of the child using defined algorithms based on the codes available at prescription records, hospital discharges and physician billing claims
Timepoint [1] 301342 0
Assessed after the third birth date of the child till the occurrence of the diagnosis or end of the study period
Primary outcome [2] 301946 0
developmental disorders, Autism Spectrum disorders, Attention deficit hyperactivity disorder, psychotic disorders, schizophrenia . All these disorders were assessed after the third birth date of the child using defined algorithms based on the codes available at prescription records, hospital discharges and physician billing claims
Timepoint [2] 301946 0
Assessed after the third birth date of the child till the occurrence of the diagnosis or end of the study period
Primary outcome [3] 302060 0
Conduct disorders, suicide attempt and substance use disorders. All these disorders were assessed after the third birth date of the child using defined algorithms based on the codes available at prescription records, hospital discharges and physician billing claims
Timepoint [3] 302060 0
Assessed after the third birth date of the child till the occurrence of the diagnosis or end of the study period
Secondary outcome [1] 333286 0
Age of developing each of primary outcomes which were assessed based on data available at Manitoba Center for Health Policy Center
Timepoint [1] 333286 0
Assessment were done from 3 to 19 years of age using databases from Manitoba center for health policy repository.
Secondary outcome [2] 334312 0
Biological sex of children were assessed for each outcome
Timepoint [2] 334312 0
Assessment was done at time of the childbirth
Secondary outcome [3] 334313 0
Socioeconomic status of the family at the time of childbirth using Canada census for income indexes
Timepoint [3] 334313 0
at the time of childbirth

Eligibility
Key inclusion criteria
All children who were exposed to antibiotics during fetal period and the first 3 years of life
Minimum age
3 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Multivariate logistic regression analyses

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
9/10/2017
Date of last participant enrolment
Anticipated
31/08/2017
Actual
19/11/2018
Date of last data collection
Anticipated
31/08/2017
Actual
19/11/2018
Sample size
Target
221139
Accrual to date
Final
221139
Recruitment outside Australia
Country [1] 8709 0
Canada
State/province [1] 8709 0
Manitoba

Funding & Sponsors
Funding source category [1] 295814 0
Self funded/Unfunded
Name [1] 295814 0
Mahin Delara
Country [1] 295814 0
Canada
Primary sponsor type
Individual
Name
Mahin Delara
Address
307 Human Ecology Building, University of Manitoba
35 Chancellor's Circle
Winnipeg MB R3T 2N2 Canada
Country
Canada
Secondary sponsor category [1] 294664 0
None
Name [1] 294664 0
None
Address [1] 294664 0
None
Country [1] 294664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297102 0
University of Manitoba Health Research Ethics Board
Ethics committee address [1] 297102 0
208-194 Dafoe Road
Winnipeg, MB R3T 2N2
Ethics committee country [1] 297102 0
Canada
Date submitted for ethics approval [1] 297102 0
29/05/2017
Approval date [1] 297102 0
01/06/2017
Ethics approval number [1] 297102 0
HS20896(H2017:207)

Summary
Brief summary
While mental illness affects 20% of Canadians of all ages, youth and children are at greater risk with a total number of staggering 3.2 million children at risk of developing depression. Seventy percent of mental health problems have their onset during childhood or adolescence. According to the Manitoba Center for Health Policy (MCHP), 11 % of children in Manitoba is prescribed at least one antidepressant over the course of a year. The rate of anxiolytic, antipsychotic and psychostimulant prescriptions in Manitoba’s children has been increasing over the last decades, and the prevalence of pervasive development disorders doubled during a ten-year study period. While a complex interplay of genetic, biological, personality and environmental factors have been identified for the etiology, the role of antibiotics is unknown. Animal models have demonstrated significant association between exposure to antibiotics and behavioral changes in mice. To date, no human study has been conducted to assess this association. To bridge the gap in the literature, this study is aimed to provide insight into the role of antibiotics in the development of a wide range of mental health/ psychiatric disorders including attention deficiet hyperactivity disorder , autism spectrum disorders, mood and anxiety disorders, psychiatric disorders, schizophrenia, developmental disorders, suicidal attempts, substance use disorders and conduct disorders. Proving a clear association between the use of antibiotics in pregnant women and their offspring, and development of psychological and behavioral disorders later in life will send a paradigm-shifting message to mothers and physicians to be cautious about prescribing and using antibiotics in pregnancy and early childhood.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 72978 0
Dr Mahin Delara
Address 72978 0
307 Human Ecology Building, University of Manitoba
35 Chancellor's Circle
Winnipeg MB R3T 2N2 Canada
Country 72978 0
Canada
Phone 72978 0
+12044748065
Fax 72978 0
Email 72978 0
[email protected]
Contact person for public queries
Name 72979 0
Dr Mahin Delara
Address 72979 0
307 Human Ecology Building, University of Manitoba
35 Chancellor's Circle
Winnipeg MB R3T 2N2 Canada
Country 72979 0
Canada
Phone 72979 0
+12044748065
Fax 72979 0
Email 72979 0
[email protected]
Contact person for scientific queries
Name 72980 0
Dr Mahin Delara
Address 72980 0
307 Human Ecology Building,University of Manitoba
35 Chancellor's Circle
Winnipeg MB R3T 2N2 Canada
Country 72980 0
Canada
Phone 72980 0
+12044748065
Fax 72980 0
Email 72980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data obtained from Manitoba Center for Health Policy (MCHP) which included anonymous identifiers for confidentially


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.