Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000115831
Ethics application status
Approved
Date submitted
14/12/2020
Date registered
4/02/2021
Date last updated
4/02/2021
Date data sharing statement initially provided
4/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Probiotics as an additional treatment in Major depressive Disorder in community: Pilot Study
Scientific title
Effectiveness of multistrain probiotics as an adjuvant treatment in Major Depressive Disorder in community: A Pilot study
Secondary ID [1] 303010 0
University of Auckland: ROC Project#3720642 (Oakley Mental Health Research Foundation)
Universal Trial Number (UTN)
U1111-1253-3400
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 320070 0
Condition category
Condition code
Mental Health 317999 317999 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.multistrain probiotics called Ecologic Barrier will be given.
strains used are Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58
2. Dose adminstered will be 5Billion CFU once daily
3.Powder reconstituted in water
4. Adherence is monitored through study specific questionnaire and face to face meetings.
5. They will continue on their standard antidepressant therapy prescribed by their treating clinician and taken as per clinician advice.
Intervention code [1] 319297 0
Treatment: Other
Comparator / control treatment
Patients suffering from Major Depressive Disorder, taking antidepressants prescribed by treating clinician and taken as per clinician advice. They will also be taking Maltodextrin powder given in a similar container to Probiotics powder described above.
Control group
Active

Outcomes
Primary outcome [1] 325999 0
Severity of symptoms of Major Depressive Disorder as measured using a scale called Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 325999 0
eight weeks after ingesting Probiotics/ Maltodextrin powder along with their usual treatment
Secondary outcome [1] 389816 0
Change in the levels of inflammatory markers Interleukin-1 and Interleukin-6 in the plasma (peripheral)
Timepoint [1] 389816 0
After 8 weeks of intervention
Secondary outcome [2] 389817 0
Food intake of participants by self-report diary
Timepoint [2] 389817 0
weekly for eight weeks
Secondary outcome [3] 390550 0
The participant's activity levels will be noted using a self-reported simple questionnaire ( how many hours a week, are you spending doing atleast moderate physical activity?) and rated based on the below Ministry of Health’s guidelines for adults, as to whether they are physically active or at present have limited activities level.

Physically active people are defined as someone who will do at least 2 ½ hours of moderate or 1 ¼ hours of vigorous physical activity spread throughout the week.

-Moderate intensity is defined as an activity that causes a slight but noticeable increase in breath and heart rate. You can still carry on a conversation.

-Vigorous-intensity is an activity that makes you out of breath – you can't do these activities and chat at the same time.
Timepoint [3] 390550 0
weekly for eight weeks

Eligibility
Key inclusion criteria
-Adults aged between 18 and 65 years

- Living in the community

-English speaking

-Able to give informed consent

-Currently experiencing an episode of MDD of mild to moderate* severity based on the Diagnostic and statistical manual of mental disorders (5th ed.)

- Attending an existing health care provider

* Mild: Few,If any, symptoms in excess of those required to make the diagnosis are present,the intensity of the symptoms is distressing but manageable,an the symptoms result in minor impairment in social or occupational functioning.

Moderate: The number of symptoms,intensity of symptoms,and/or functional impairment are between those specified for ‘mild’ and “severe”.

Severe: The number of symptoms is substantially in excess of that required to make the diagnosis,the intensity of the symptoms is seriously distressing and unmanageable,and the symptoms markedly interfere with social and occupational functioning.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Illnesses that contribute to immunosuppression or inflammatory conditions

-People who take immunosuppressants

-Currently suffering from an infection and have been taking antibiotics

-On regular medications other than antidepressants especially those which affect the gut microbiota (e.g., Omeprazole, over the counter probiotics) or anti-inflammatory medications like NSAID’s.

-Acutely suicidal or at high risk of harming others or properties

-Currently diagnosed with Schizophrenia, Schizoaffective disorder or eating disorder

- Have been diagnosed with Bipolar Affective disorder in the past

- Any form of substance abuse or dependence in the last two years.

-Significant comorbid physical illnesses, e.g., autoimmune disorders, inflammatory bowel conditions, traumatic brain injury, neurological disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered opaque containers - one group will contain the placebo powder and one group will have the active ingredient and only Principal Investigator will know them.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple Randomisation- Computerized Sequence Generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/03/2021
Actual
Date of last participant enrolment
Anticipated
31/08/2021
Actual
Date of last data collection
Anticipated
26/10/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 23289 0
New Zealand
State/province [1] 23289 0
Auckland

Funding & Sponsors
Funding source category [1] 307421 0
Other
Name [1] 307421 0
Oakley Mental Health Research Foundation
Country [1] 307421 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
22-30 Park Ave
Grafton
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 308089 0
Individual
Name [1] 308089 0
Dr.Fredrick Sundram
Address [1] 308089 0
University of Auckland-Grafton campus
Park Road
Auckland 1010
Country [1] 308089 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307503 0
New Zealand Ministry of Health and Disability Ethics Committees
Ethics committee address [1] 307503 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 307503 0
New Zealand
Date submitted for ethics approval [1] 307503 0
09/09/2020
Approval date [1] 307503 0
03/12/2020
Ethics approval number [1] 307503 0
20/STH/168

Summary
Brief summary
We are planning a Pilot study to look at the effectiveness of ingesting a multistrain probiotics for eight weeks in the treatment of Major Depressive Disorder in community along with conventional biological treatment, antidepressants.Apart from the above, study also tries to clarify whether there will be a change in the levels of inflammatory markers called interleukin 1 and 6 due to the above intervention and does people's eating and lifestyle have any confounding effect in the above relationship.
Trial website
Trial related presentations / publications
Public notes
Although probiotics are used over the counter for the above condition, understanding this relationship better within the evidence based framework will boost the possibility of a more Holistic treatment to this condition in the near future. it will also help us in getting approval from Governments to consider funding this treatment option.

Contacts
Principal investigator
Name 107466 0
Dr Fredrick Sundram
Address 107466 0
Senior Lecturer
Faculty of Medical and Health Sciences
University of Auckland-Grafton Campus
Grafton
Auckland 1010
Country 107466 0
New Zealand
Phone 107466 0
+64 9 923 7521
Fax 107466 0
Email 107466 0
f.sundram@auckland.ac.nz
Contact person for public queries
Name 107467 0
Dr Venkat Krishnamurthy Naga
Address 107467 0
Honorary
Faculty of Medical and Health Sciences
University of Auckland
Grafton
Auckland 1010
Country 107467 0
New Zealand
Phone 107467 0
+64 2040783021
Fax 107467 0
Email 107467 0
vkri010@aucklanduni.ac.nz
Contact person for scientific queries
Name 107468 0
Dr Venkat Krishnamurthy Naga
Address 107468 0
Honorary
Faculty of Medical and Health Sciences
University of Auckland
Grafton
Auckland 1010
Country 107468 0
New Zealand
Phone 107468 0
+64 2040783021
Fax 107468 0
Email 107468 0
vkri010@aucklanduni.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual raw data will be shared only with Health care provider of that person, if needed. Otherwise it will remain confidential.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10033Informed consent form    381102-(Uploaded-14-12-2020-10-25-57)-Study-related document.docx
10034Study protocol    381102-(Uploaded-14-12-2020-10-25-18)-Study-related document.docx


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10033Informed consent form    381102-(Uploaded-09-08-2021-19-07-04)-Study-related document.docx
10034Study protocol    381102-(Uploaded-09-08-2021-19-08-06)-Study-related document.docx

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.