Protocol summary
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Study aim
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The aim of this study is to determine the effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram.
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Design
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Among patients with major depressive referred to the Kargarneghad Clinic affiliated to Kashan Medical Sciences University, Kashan, Iran, 40 patients will be selected. The study will be double blind in which participants and investigators/the assessors of the outcomes are unaware of the study groups and drug and placebo are similar. Fasting blood samples will be taken at baseline and end of the intervention. Intervention period: 8 weeks.
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Settings and conduct
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40 patients with major depressive disorder of eligible and referred to Karganejad hospital to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with major depressive, aged between 20 to 55 years.
Exclusion criteria: Age <20 y or >55 y; a history of coronary infarction, angina pectoris, pregnancy or lactation, substance abuse; taking dietary supplements or probiotic supplements during the previous 2 months
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Intervention groups
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Patients will be assigned to receive either the probiotic capsule (intervention group: n=20) or placebo capsule (control group: n=20).
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Main outcome variables
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Beck Depression Inventory (primary outcome), and glycemic control, lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes)
General information
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Reason for update
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Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2014060717993N1
Registration date:
2014-11-04, 1393/08/13
Registration timing:
retrospective
Last update:
2020-10-12, 1399/07/21
Update count:
1
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Registration date
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2014-11-04, 1393/08/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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TAK GENE ZIST Co , Tehran , Iran. Kashan University of Medical Sciences.
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Expected recruitment start date
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2014-07-01, 1393/04/10
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Expected recruitment end date
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2014-07-15, 1393/04/24
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of probiotic capsule supplementation on severity depression among patients with major depressive disorder under treatment with citalopram
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Public title
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The effect of probiotic capsule supplementation on severity depression
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with major depressive
Aged between 20 to 55 years
Exclusion criteria:
Age <20 y or >55 years
A history of coronary infarction
Angina pectoris
Pregnancy or lactation
Substance abuse
Taking dietary supplements or probiotic supplements during the previous 2 months
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Age
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From 20 years old to 55 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 40 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic, who is not involved in the trial and not aware of random sequences, will assign the participants to the numbered bottles of drugs. Supplements and placebos are in the same packaging at the Tak Gen Zist pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of intervention. After analyzing the data, pocket codes will be decoded. Participants and investigators/the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-06-09, 1393/03/19
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Ethics committee reference number
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93044
Health conditions studied
1
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Description of health condition studied
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Depression
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ICD-10 code
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F32
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ICD-10 code description
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Depressive episode
Primary outcomes
1
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Description
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Severity depression
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Questionnaire Beck
Secondary outcomes
1
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Calculation using the Homeostasis Model Assessment (HOMA) formula
2
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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ELISA kit
3
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
6
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Description
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High-density lipoprotein (HDL)
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
7
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Description
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Low-density lipoprotein (LDL)
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Enzymatic kit
8
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Description
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High-sensitivity C-reactive Protein (hs-CRP)
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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ELISA kit
9
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Spectrophotometry
Intervention groups
1
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Description
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Multi species probiotic capsules containing Lactobacillus acidophilus 2× 109 CFU, Lactobacillus casei 2× 109 CFU, Bifidbacterium bifidum 2 × 109 CFU.
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Category
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Placebo
2
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Description
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Control group: Placebo capsule, daily, for 8 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Research Department of Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable