IRCT | The effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on Quality of life (physical and mental health status) in women with polycystic ovarian syndrome.

Protocol summary

Study aim: Determining the effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on the life quality (physical and mental health status) of women with polycystic ovary syndrome.
Design: A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 60 patients. Block randomization method is used for randomization.
Settings and conduct: 60 women over 18 years old with PCOS will be invited to participate. Then patients are asked to fill PCOSQ-26, SF-12 and PSS-10 questionnaires. Then the patients are randomly assigned to two groups, treatment or control. At the begining, the set of sachets containing synbiotic supplements or placebo are coded by the factory as A and B so that the researcher, statistical analyst and patients will stay uninformed.
Participants/Inclusion and exclusion criteria: inclusion criteria: Having polycystic ovary syndrome according to Rotterdam criteria, At least 2 weeks have passed since the diagnosis and treatment of PCOS, age range of over 18 years, BMI range of 18-5-35 Exclution criteria: pregnancy, suffering from liver diseases, suffering from kidney failure and heart failure, infectious or inflammatory diseases, suffering from thyroid disorders, diabetes, cancer, hyperprolactinemin, synbiotics or probiotics products in the last month, Use of antibiotics in the last three months, Adherence to special diets or weight loss diets during the last three months and Use of corticosteroids, omega-3
Intervention groups: The intervention will be carried out for 12 months on two treatment and control groups, who will receive 2 grams of synbiotic sachets containing Bacillus coagulans and fructooligosaccharide or 2 grams of placebo sachets, respectively.
Main outcome variables: Emotional, Hirsotism, weight, Infertility and menstrual scores of PCOSQ-26 Physical and mental performance scores (SF12) PSS-10 score

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20211108053007N1

Registration date: 2023-02-14, 1401/11/25

Registration timing: prospective

Last update: 2023-02-14, 1401/11/25

Update count: 0
Registration date: 2023-02-14, 1401/11/25

Registrant information: Name

Zahra Hariri

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 21 2235 7483

Email address

hariri.nut@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-02-19, 1401/11/30
Expected recruitment end date: 2023-05-21, 1402/02/31
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on Quality of life (physical and mental health status) in women with polycystic ovarian syndrome.

Public title: The effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on Quality of life (physical and mental health status) in women with polycystic ovarian syndrome.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria At least 2 weeks have passed since the diagnosis and treatment of PCOS Being in the age range of 18-45 years Being in the BMI range of 18.5-35 Willingness to cooperate

Exclusion criteria:

pregnancy Having liver diseases, kidney failure and heart failure, infectious or inflammatory diseases, thyroid gland disorders, diabetes, types of cancer and hyperprolactinemia. Consuming supplements or products containing synbiotics or probiotics in the last month Adherence to special diets or weight loss diets during the last three months Taking corticosteroids or omega-3
Age: From 18 years old to 45 years old
Gender: Female

Phase

3

Groups that have been masked

Participant
Investigator
Data analyser

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

In order to randomly assign women, stratified block randomization method is used based on BMI, the use of hormonal drugs that regulate the menstrual cycle, and metformin.

Blinding (investigator's opinion)

Triple blinded

Blinding description

Placebo sachets are completely similar in appearance to synbiotic sachets. In order to carry out this research in a three-blind manner, at the time of the start of the study, the set of sachets containing synbiotic or placebo supplements are coded as A and B by the factory so that the researcher, statistical analyst and patients are not informed about the type of supplements received by each group.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of vice-chancellor in Research Affairs - Shahd Beheshti University of Med

Street address

Ground floor, Building No. 2, Aarabi St,. Daneshjoo Blvd., Yaman St., Chamran Hwy.

City

Tehran

Province

Tehran

Postal code

1998743664
Approval date: 2023-02-12, 1401/11/23
Ethics committee reference number: IR.SBMU.RETECH.REC.1401.703

Health conditions studied

1

Description of health condition studied: Polycystic Ovary Syndrome
ICD-10 code: E28.2
ICD-10 code description: Polycystic ovarian syndrome

Primary outcomes

1

Description: Emotional domain score of PCOSQ-26
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: PCOSQ-26 form

2

Description: Hirsotism domain score of PCOSQ-26
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: PCOSQ-26 form

3

Description: Weight domain score of PCOSQ-26
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: PCOSQ-26 form

4

Description: Infertility Problems domain score of PCOSQ-26
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: PCOSQ-26 form

5

Description: Menstrual Problems domain score of PCOSQ-26
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: PCOSQ-26 form

6

Description: Physical functioning score
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: SF-12 form

7

Description: Physical functioning score
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: SF-12 form

8

Description: Perceived Stress scale (PSS-10) score
Timepoint: At the beginning and 12 weeks after the start of the intervention
Method of measurement: PSS-10 form

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: For 12 weeks, they will receive daily one 2 gram sachet of synbiotic containing 10 to the power of 11 CFU/g of Bacillus coagulans, 10 to the power of 10 CFU/g Lactobacillus rhamnus, 10 to the power of 10 CFU/g Lactobacillus heloticus, 500 mg fructo-oligosaccharide and 0.7% orange flavor.
Category: Treatment - Drugs

2

Description: Control group: They will receive a placebo sachet daily containing 2 grams of starch and 0.7% orange flavoring.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Women's and pcos clinic of Ayatollah Taleghani Hospital

Full name of responsible person

Zahra Hariri

Street address

Shahid Aarabi St., Yaman St., Chamran Hwy.

City

Tehran

Province

Tehran

Postal code

1998743664

Phone

+98 21 2243 2560

Email

taleghani@sbmu.ac.ir

Web page address

https://taleghani.sbmu.ac.ir/

1

Sponsor: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Maryam Rezvani Fard

Street address

Ground floor, buliding No. 2, Shahid Aarabi St., Yemen St., Chamran Hwy.

City

Tehran

Province

Tehran

Postal code

1998743664

Phone

+98 21 23871

Email

info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shahid Beheshti 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

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Zahra Hariri

Position

MCS Student

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town

City

Tehran

Province

Tehran

Postal code

1998743664

Phone

+98 21 2676 4689

Email

nutrition@sbmu.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Zahra Hariri

Position

MCS Student

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town

City

Tehran

Province

Tehran

Postal code

1998743664

Phone

002126764689

Email

hariri.nut@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Zahra Hariri

Position

MCS student

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town

City

Tehran

Province

Tehran

Postal code

1998743664

Phone

+98 21 2676 4689

Email

hariri.nut@gmail.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: Only part of the data, such as the main results, will be shared.
When the data will become available and for how long: The beginning of the access period is 12 months after the publication of the results
To whom data/document is available: It will be available for researchers working in academic and scientific institutions and industry.
Under which criteria data/document could be used: The documentation can only be used for more complete studies in this field.
From where data/document is obtainable: Zahra Hariri
What processes are involved for a request to access data/document: Communication will be possible through the email given in the previous section
Comments

The effects of synbiotic supplement containing Bacillus coagulans and fructooligosaccharide on Quality of life (physical and mental health status) in women with polycystic ovarian syndrome.