Determining the effect of probiotic supplementation on the sexual function of perimenopausal and menopausal women
Design
A controlled clinical trial with two parallel groups, double blinded, randomized with blocking method, phase three on 64 participants. The random.org website will be used for randomization.
Settings and conduct
This study will be performed in health Centers of Tabriz.
Eligible people will be classified by random block method with block sizes of 4 and 6 and with allocation ratio of 1:1 into two groups.
Participants will take one 250 mg capsule daily at lunch with a glass of water for eight weeks.
Participants, researcher, data analyst and outcome assessor will be blinded. Medicine and placebo will be identical in appearance and in similar bottles.
Participants/Inclusion and exclusion criteria
Entry: married women 40 to 60 years old
Having sex at least twice a month
Her husband's monogamy
Women's sexual function index questionnaire score FSFI>28 in the initial evaluation
A minimum of 12 months and a maximum of 10 years have passed since menopause
Exclusion: Use of immunosuppressive drugs
Use of drugs affecting sexual performance
History of hormonal treatment during the last two weeks
Bleeding or spotting after intercourse, vaginal infection
The presence of chronic diseases such as heart disease, diabetes, lupus, mental disorders, etc.
History of complete hysterectomy
Anatomical deformity of the external genitalia
History of pelvic chemotherapy and radiation therapy
Severe emotional stress during the 3 months before
Use of herbal medicines
Urinary incontinence
Couple's addiction
Intervention groups
The intervention group will use a 250 mg probiotic capsule daily in lunch with a glass of water for eight weeks, and the control group will receive a placebo capsule similar to the treatment group.
Main outcome variables
Average score of sexual performance and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N83
Registration date:2024-05-11, 1403/02/22
Registration timing:prospective
Last update:2024-05-11, 1403/02/22
Update count:0
Registration date
2024-05-11, 1403/02/22
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic supplementation on sexual function in perimenopausal and menopausal women: A randomized controlled clinical trial
Public title
The effect of probiotic supplementation on sexual performance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 40 to 60 years with menstrual irregularity or menopause
Having sex at least twice a month
Her husband being monogamous
Women's sexual function index questionnaire score FSFI<28 in the initial assessment
A minimum of 12 months and a maximum of 10 years have passed since menopause in menopausal people
Occurrence of natural menopause in menopausal people and not following hysterectomy surgery or GnRH receptor agonist drugs
Exclusion criteria:
Allergy to any of the products containing probiotics
Use of any immunosuppressive drugs
Use of drugs that affect sexual performance by the person himself or his wife
History of hormonal treatment due to sexual dysfunction during the last two weeks
Bleeding or spotting after intercourse, vaginal infection
Women who use sexual performance enhancing drugs
Addiction of spouses to drugs or alcohol
The presence of chronic diseases such as heart disease, diabetes, lupus, mental disorders, etc.
History of complete hysterectomy
Anatomical deformity of the external genitalia
History of pelvic chemotherapy and radiotherapy
Severe emotional stress during the 3 months before the start of the study
Use of phytoestrogens and other herbal medicines
Urinary incontinence
Age
From 40 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible people were classified by random block method (according to menopausal status, perimenopause or menopause) with block size of 4 and 6 and with allocation ratio of 1:1 into two intervention (probiotic capsule) and control (placebo) groups. will be allocated.
Blinding (investigator's opinion)
Double blinded
Blinding description
For allocation concealment and blinding, probiotic and placebo capsules will be placed in exactly the same opaque bottles numbered consecutively. Allocation sequence concealment will be done by someone other than the person involved in sampling and data collection. The bottles will be given to the participants in the order of entering the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2024-04-17, 1403/01/29
Ethics committee reference number
IR.TBZMED.REC.1403.034
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
sexual dys
ICD-10 code description
F52
Primary outcomes
1
Description
Average sexual performance score
Timepoint
At the beginning of the study and eight weeks after the start of the intervention
Method of measurement
Female Sexual Function Index (FSFI) questionnaire
Secondary outcomes
1
Description
Average quality of life score
Timepoint
At the beginning of the study and eight weeks after the start of the study
Method of measurement
Menopause-Specific Quality of Life questionnaire
Intervention groups
1
Description
Intervention group: Participants (32 people) will take one 250 mg probiotic capsule daily at lunch, before or between meals with a full glass of water for eight weeks.
Category
Treatment - Drugs
2
Description
Control group: Participants (32 people) will take one 250 mg placebo capsule daily at lunch, shortly before or between meals with a full glass of water for eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Community health centers of Tabriz
Full name of responsible person
Roghayyeh Valizadeh
Street address
Community health centers of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5143814998
Phone
+98 41 3444 0057
Email
iro@tbzmed.ac.ir
Web page address
http://tabriz-phc.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
dabirkhanecent@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Roghayyeh Valizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5135963777
Phone
+98 41 3523 0741
Email
r.valizadeh31@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available