Investigating the effect of probiotic supplementation in improving symptoms of depression, anxiety, insomnia, anorexia and cognitive impairment in HIV-positive patients, a three-blind randomized clinical trial with placebo control.
Evaluation the effect of probiotic supplementation on the symptoms of psychiatric disorders such as anxiety and depression, sleep disorder and cognitive disorder in HIV patients and improving their personal and social function.
Design
After the eligibility of the patient is recognized and written informed consent is received, the patients will be assigned to intervention and (placebo) groups by block randomization method with unequal block sizes of 2, 4, and 6. A randomization list is prepared.
Settings and conduct
This is a triple-blind randomized study (patient, outcome measurement researcher, and data analyst). The population is HIV-positive people who meet the inclusion criteria are among outpatients referred to Sabzeh Parvar Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria
No past history of treating psychotic disease
Over 18 years of age
IQ above 70
No ECT in the last two weeks
No alcohol ,stimulants and drugs abuse
CD4 level above 350
HIV positive patients who refer as outpatients
willingness to participate
In case of depression disorder, anxiety disorder, sleep disorder, and cognitive disorder start drug treatment
Exclusion criteria
Prominent neurological or organic disease and cardiovascular disease
Another diagnosis in Axis I based on DSM-V
IQ less than 70 based
Abusing of other substances (except nicotine and caffeine)
Taking oral antipsychotics in the past week or long-acting antipsychotics in the past month
Receiving ECT in the last two weeks
Women will not be accepted without adequate methods of contraception
CHF and liver disease
Intervention groups
25 people in the intervention group are treated with one capsule of acidophilus-bifidum and plantarum probiotics (twice a day) and 25 people in the control group are given 1 placebo capsule of starch twice a day.
Investigating the effect of probiotic supplementation in improving symptoms of depression, anxiety, insomnia, anorexia and cognitive impairment in HIV-positive patients, a three-blind randomized clinical trial with placebo control.
Public title
The effect of probiotics in improving symptoms of anxiety, depression and appetite in HIV positive patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years of age
IQ above 70
No consumption of alcohol, drugs and stimulants in the last three months based on the result of the urine test
CD4 level above 350 in the last three months
HIV-positive patients are outpatients and not hospitalized and in controlled physical conditions with the approval of an infectious disease specialist
Voluntary willingness of the individual to participate in the plan
Exclusion criteria:
prominent neurological or organic disease and cardiovascular disease and history of cardiac surgery or any cardiovascular procedure clinical and laboratory examinations and family history
Another diagnosis in Axis I based on DSM-V
abusing of other substances (except nicotine and caffeine)
taking oral antipsychotics in the past week or long-acting antipsychotics in the past month
receiving ECT in the last two weeks
women of childbearing age will not be accepted without adequate methods of contraception
CHF and liver disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After the eligibility of the patient is recognized and written informed consent is received, the patients will be assigned to one of two intervention and comparison (placebo) groups by block randomization method with unequal block sizes of 2, 4, and 6. Prepare a randomization list becomes To prepare the randomization list, from the web-based software to the address
https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used.
Allocation concealment In order to hide the allocation, the sequence of allocation will be hidden by choosing the size of non-matching blocks. Also, the specific group of each patient will be placed in envelopes and the number of the envelope will match the order of sequence and the order of identification of the patient. At the time of identification of each patient, one of these envelopes will be opened.
Blinding (investigator's opinion)
Triple blinded
Blinding description
A placebo will be used to blind the patient. In this way, materials similar to probiotics in terms of color, taste, shape, and size are sold with the help of the pharmaceutical company.
The researcher investigating the outcome and analyzing the data: He is not aware of the patient's random allocation group, and only the researcher who has the random list is aware of this issue.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics Committee Office, 2nd floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Gol-shahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.ABZUMS.REC.1402.013
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus [HIV] disease
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
2
Description of health condition studied
depressive disorder
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
3
Description of health condition studied
Insomnia
ICD-10 code
F51.0
ICD-10 code description
Insomnia not due to a substance or known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study, 4th ,8th ,and 12th weeks
Method of measurement
The Beck Anxiety Inventory (BAI)
2
Description
Anorexia
Timepoint
At the beginning of the study, 4th ,8th ,and 12th weeks
Method of measurement
Simple appetite questionnaire
3
Description
sleep quality
Timepoint
At the beginning of the study, 4th ,8th ,and 12th weeks
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
4
Description
cognitive impairment
Timepoint
At the beginning of the study, 4th ,8th ,and 12th weeks
Method of measurement
Montreal cognitive assessment(MoCA)
Secondary outcomes
1
Description
Mild gastrointestinal discomfort
Timepoint
At the beginning of this study, 4th ,8th and 12th weeks
Method of measurement
Medical history
Intervention groups
1
Description
Intervention group: lactobacillus acidophilus capsule twice per day 10 exponent 8 unit daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Starch placebo tablets exactly the same with probiotic capsules for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sabze Parvar Health Care Center
Full name of responsible person
Amirhossein Hajialigol
Street address
Shahid Sabze Paror Health Care Center , Takhti Street,45-meter Kaj (Azeimieh) Street,, Azadegan Square
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3252 2415
Email
Ah.hajialigol@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hatam Godini
Street address
Safarian St , Golshahr Ave, Karaj
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Atefe Zandifar
Position
Assistant professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Ali hospital, beginning of Kaj blvd., Karaj
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3250 0123
Email
emamali@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Atefe Zandifar
Position
Assistant professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Ali hospital, beginning of Kaj blvd., Karaj
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3250 0123
Email
emamali@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Atefe Zandifar
Position
Assistant professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Ali hospital, beginning of Kaj blvd., Karaj
City
karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3250 0123
Email
emamali@abzums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
We are going to share required data
When the data will become available and for how long
available on March 2023
To whom data/document is available
Public article
Under which criteria data/document could be used
Unconditional
From where data/document is obtainable
Publisher journal or please sent massage to ah.hajialigol@gmail.com
What processes are involved for a request to access data/document