The effect of probiotic consumption on fatigue and sexual function in postmenopausal women
Design
Control group: placebo will be prescribed in the form of Oral Capsule contain ُof Starch 200 mg Once a day for 6 weeks. The placebo is made in Hamadan University of Medical Sciences.
Settings and conduct
comprehensive health centers in Hamedan city
Participants/Inclusion and exclusion criteria
age between 45-55, not using cigarette or alcohol, not having physical or mental diseases, not using of relaxation techniques, not using of hormonal or herbal therapies, at least 1 to 5 years have passed since menopause
Intervention groups
Intervention group: Probiotic supplement will be prescribed in the form of Oral Capsule 200 mg, Once a day for 6 weeks. Including Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnusos,Bifidobacterium Lactis, Bifidobacterium longum, Bifidobacterium breve and with dose CFU 3×109.This drug Will be Producted by Company of Zist Takhmir.
Main outcome variables
Fatigue severity; Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040370N11
Registration date:2024-08-16, 1403/05/26
Registration timing:prospective
Last update:2024-08-16, 1403/05/26
Update count:0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic consumption on fatigue and sexual function in postmenopausal women
Public title
The effect of probiotic consumption on fatigue and sexual function in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 45-55
not using cigarette or alcohol
not having physical or mental diseases
not using of relaxation techniques
not using of hormonal or herbal therapies
at least 1 to 5 years have passed since menopause
Exclusion criteria:
Age
From 45 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly selected by random.org computer program that are assigned to the two groups of 40 recipients of capsule Probiotic and placebo. The allocation of the participants to the groups is performed by method of allocation concealment. In this way, using the random block 4, the allocation sequence is specified. Then, in the sealed envelopes, the intervention name is written in sequential order, and is numbered accordingly.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug packages are similar and were given to menopausal women by other person. This person does not inform about the package contents. therefore, neither the researcher nor the menopausal women and the analyzer knows the contents of the package and double triple blinding will be performed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی همدان
Street address
Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan
City
همدان
Province
Hamadan
Postal code
6517838678
Approval date
2024-08-03, 1403/05/13
Ethics committee reference number
IR.UMSHA.REC.1403.273
Health conditions studied
1
Description of health condition studied
fatigue severity and sexual function in postmenopausal women
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Fatigue severity
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Fatigue Severity Scale (ّFFS)
2
Description
Sexual function
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Female Sexual Function Index
Secondary outcomes
1
Description
Menopausal quality of life
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Menopause-Specific Quality of Life (MENQOL)
Intervention groups
1
Description
Intervention group: Probiotic supplement will be prescribed in the form of Oral Capsule 200 mg, Once a day for 6 weeks. Including Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnusos,Bifidobacterium Lactis, Bifidobacterium longum, Bifidobacterium breve and with dose CFU 3×109.This drug Will be Producted by Company of Zist Takhmir.
Category
Treatment - Drugs
2
Description
Control group: Control group: placebo will be prescribed in the form of Oral Capsule contain ُof Starch 200 mg Once a day for 6 weeks. The placebo is made in Hamadan University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Service Center of Shohada
Full name of responsible person
Ensiyeh Jenabi
Street address
Comprehensive Health Service Center of Shohada., Takhti Ave., Hamadan
City
همدان
Province
Hamadan
Postal code
6517838344
Phone
+98 81 3252 4321
Email
Shohada.health@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Av
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3131 4058
Email
R_shokouhi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1938
Email
en.jenabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1938
Email
en.jenabi@yahoo.cim
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1938
Email
en.jenabi@yahoo.com
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
A portion of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data analysis is permitted with the author's permission.
From where data/document is obtainable
Hamadan ،Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Responsible person: Ensiyeh Jenabi Postal code: 6517838695 Phone number: +98 81 38381938 Email: en.jenabi@yahoo.com
What processes are involved for a request to access data/document
Requests should be submitted to the corresponding author via email. He will follow up with the inquiry.