Home » Trials » SLCTR/2025/016
Effectiveness of probiotics as an adjunct to standard treatment among newly diagnosed patients requiring treatment for depression : A double blind randomized control trial
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SLCTR Registration Number
SLCTR/2025/016
Date of Registration
The date of last modification
Apr 23, 2025
Scientific Title of Trial
Effectiveness of probiotics as an adjunct to standard treatment among newly diagnosed patients requiring treatment for depression : A double blind randomized control trial
Public Title of Trial
The effectiveness of probiotics versus placebo as an add on treatment to standard treatment in out patients with newly diagnosed depressive episodes at the psychiatry out patients clinics at Teaching Hospital Peradeniya
Disease or Health Condition(s) Studied
Depression
Scientific Acronym
None
Public Acronym
None
Brief title
Effectiveness of probiotics in the treatment of depression
Universal Trial Number
U1111-1320-3291
Any other number(s) assigned to the trial and issuing authority
2024/EC/35 (ERC, Faculty of Medicine, Peradeniya)
What is the research question being addressed?
What is the effectiveness of the addition of a probiotic vs a placebo to standard treatment for patients with newly diagnosed depression?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Data analysts, Healthcare providers, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study setting: Out Patients Department at Teaching Hospital Peradeniya
Randomization method: Block randomization
Intervention: Participants will receive the probiotic in capsule form to be taken once daily, 30 minutes before breakfast for 6 months. The capsule contains Lactobacillus helveticus, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium brevis). Probiotic strength is 60 billion per gram which amounts to 21 billion CFU per capsule.
Control arm: Participants will receive a matching starch containing placebo, identical to the probiotic capsule, manufactured by the Department of Pharmacy, Faculty of Allied Health Sciences, University of Peradeniya. This is to be taken once daily, 30 minutes before breakfast for 6 months.
Blinding details Block randomization will be carried out with a block size of 12. Participants will be allocated to 3 groups according to the severity as mild, moderate and severe depression depending on the score on the depression measurement tool . All the patients in each of the 3 groups will then be randomly allocated to one of two arms- treatment as usual arm or treatment as usual with the additional probiotic arm. Allocation to each arm will be done by one investigator who will maintain a electronic log of which patient was allocated to each arm.
Allocation concealment will be done by a central coordinator who will use sequentially numbered, opaque, sealed envelopes for each patient. The 3 categories of depression will be in 3 different colors assigned by the treating consultant. None of the research assistants will be aware as to which level of depression each color represents.
Inclusion criteria
Exclusion criteria
1.History of a past episode of depression at any point of time 2.History of a single manic episode or bipolar disorder 3.History of, or current eating disorders 4.Personality disorders 5.Serious medical illness, gastrointestinal disease or surgery 6 Current or regular gastrointestinal medication 7. Pregnancy or breastfeeding 8. Co morbid substance use disorder amounting to dependence 9. Co morbid diagnosis of schizophrenia or dementia 10. Being on probiotics at the time of the study or the past 12 weeks 11. Being on antibiotics at the time of the study 12. Adverse reactions to products containing probiotics in the past
Primary outcome(s)
|
1.
Clinical severity of depression as scored on the Becks Depression Inventory |
[ On day one and monthly for a total of 6 months ] |
Secondary outcome(s)
|
1.
Score on the Life Change Index Scale (The Stress Test) |
[ On day one and monthly for a total of 6 months ] |
Target number/sample size
144 (72 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2025-04-28
Anticipated end date
2026-02-16
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University Research Grant
Regulatory approvals
Not Applicable
Status
Approved
Date of Approval
2025-01-17
Approval number
2024/EC/35
Details of Ethics Review Committee
| Name: | Ethics Review Committee |
| Institutional Address: | Faculty of Medicine, University of Peradeniya |
| Telephone: | 0812389106 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr Sayuri Perera
Senior Lecturer and Consultant Psychiatrist
Department of Psychiatry, Faculty of Medicine, University of Peradeniya
0812396000
0777214399
sayuperera@yahoo.com
Contact Person for Public Queries
Dr Sayuri Perera
Senior Lecturer and Consultant Psychiatrist
Department of Psychiatry, Faculty of Medicine, University of Peradeniya
0812396000
0777214399
sayuperera@yahoo.com
Primary study sponsor/organization
University Research Committee
University of Peradeniya, Sri Lanka
0812392000
secretaryurc@gs.pdn.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All the de-identified individual participant data, statistical analysis plan and consent forms will be made available on request to anyone who wishes to access the data. Requests can be directed to the Principal Investigator.
Study protocol available
Yes
Protocol version and date
Version 3.0 (Uploaded)
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
