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Effects of probiotic supplements on clinical, endocrine and immunological parameters in woman with polycystic ovarian syndrome (PCOS)

Protocol summary

Summary
The aims of study is to investigate the effects of probiotic supplement on clinical, endocrine, and immunological profile in women with poly cystic ovary syndrome Study design: Randomized, double-blind, placebo- controlled trial, single-center Inclusion criteria: age between 18 to 45 years ild; not using any kind of medication or supplements except Cyproterone acetate compound; no history of any chronic disease (diabetes, thyroid disease, autoimmune, cancer,..) during trial; not being professional athlete; no desire for following up an infertility treatment for the next months. Exclusion criteria: smoking; pregnancy; lactation; tend to pregnancy for next three months; getting common cold or flu more than 5 days during trial; no desire for cooperation; making the major change in diet or physical activity during trial; using any immune-oppressive medication. Sample size: 60. Intervention: probiotic supplement (lactoBacillus 1000000000 CFU) 2 times per day, and maltodextrin capsule as a placebo. Duration of intervention: 3 months. Study outcomes: measuring hormones profile (LH, FSH, DHEA, and Testestrone), serum glucose, insulin, IL-6, IL-10, hs_CRP, dominant follicle, ovary size in the middle of cycle Second outcomes: Lipid profile, weight, BMI, waist circumstance, HOMA-IR, The number of days of the menstrual cycle.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081429362N1
Registration date: 2016-09-08, 1395/06/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-08, 1395/06/18
Registrant information
Name
Nila Ghanei
Name of organization / entity
National nutrition and food technology institute, school of nutrition and food sciences, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 0656
Email address
nilaghanei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
National Nutrition and Food Technology Institute of Iran, Shahid Beheshty University of Medical Science
Expected recruitment start date
2016-07-09, 1395/04/19
Expected recruitment end date
2016-09-09, 1395/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic supplements on clinical, endocrine and immunological parameters in woman with polycystic ovarian syndrome (PCOS)
Public title
The effects of Lacatobacillus on poly cystic onarian syndrom (PCOS)
Purpose
Treatment
Inclusion/Exclusion criteria
Target population sample of women with poly cystic ovary syndrome in women with poly cystic ovary syndrome referred to Ebne Sina hospital, Tehran, Iran. Inclusion criteria: age between 18 to 45 years ild; not using any kind of medication or supplements except Cyproterone acetate compound; no history of any chronic disease (diabetes, thyroid disease, autoimmune, cancer,..) during trial; not being professional athlete; no desire for following up an infertility treatment for the next months. Exclusion criteria: smoking; pregnancy; lactation; tend to pregnancy for next three months; getting common cold or flu more than 5 days during trial; no desire for cooperation; making the major change in diet or physical activity during trial; using any immune-oppressive medication.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Nutrition Sciences and Food Technology , Shahid Beheshti University of Medical SciencesSci
Street address
West Arghavan St, Farahzadi Blv, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-06-25, 1395/04/05
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1395.54

Health conditions studied

1

Description of health condition studied
poly cystic ovary syndrome (PCOS)
ICD-10 code
IV
ICD-10 code description
E28.2

Primary outcomes

1

Description
hs-CRP
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

2

Description
IL-6
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

3

Description
IL-10
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

4

Description
LH
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

5

Description
FSH
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

6

Description
DHEA
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

7

Description
TESTOSTERONE
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

8

Description
serum insulin
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
Eliza

9

Description
serum glucose
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
enzymatic method

10

Description
dominant follicle
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
ultrasound (sonography)

11

Description
ovary size
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
ultrasound (sonography)

Secondary outcomes

1

Description
TG
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
enzymatic

2

Description
weight
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
weight scale

3

Description
LDL
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
enzymatic

4

Description
waist circumstance
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
meter

5

Description
BMI
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
weight(kg)/height2(m2) (Metric Units)

6

Description
HOMA-IR
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
{[fasting insulin (µU/ml)] × [fasting glucose (mmol/l)]}/22.5

7

Description
The number of days of the menstrual cycle
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
questioner

8

Description
HDL
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
enzymatic

9

Description
total cholesterol
Timepoint
beginning of trial/ end of trial (3 months later)
Method of measurement
enzymatic

Intervention groups

1

Description
probiotic Lactobacillus/109 CFU/ 2 times per day/ for 3 months/ keep in the refrigerator/ Lactobacillus acidophilus Lactobacillus plantarum Lactobacillus fermentum Lactobacillus gasseri Fructooligosaccharides
Category
Treatment - Drugs

2

Description
placebo: maltodextrin/ made by same company with exact shape, size, color/ 2 times per day/ for 3 months/ keep in the refrigerator
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebne Sina clinic
Full name of responsible person
Dr Ali Amiri (OB,GYN)
Street address
5th floor, Ebne Sina Clinic, Sadeghieh second SQ, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Nutrition and Food Sciences Institute Iran, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Esmat Naseri
Street address
National Nutrition and Food Sciences Institute, West Arghavan, Farahzadi Blvd.Teh, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Sciences Institute Iran, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nila Ghanei
Position
PhD student of nutrition
Other areas of specialty/work
Street address
National Nutrition and Food Technology Institute of IRAN. Shahid Beheshti University of Medical Sciences, West Arghavan, Farahzadi Blvd.
City
Tehran
Postal code
Phone
+98 21 2236 0656
Fax
Email
nilaghanei@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Esmat Nasseri
Position
PhD in Nutriton Sciences
Other areas of specialty/work
Street address
National Nutrition and Food Technology Institute of IRAN. Shahid Beheshti University of Medical Sciences, West Arghavan, Farahzadi Blvd.
City
Tehran
Postal code
Phone
+98 21 2236 0656
Fax
Email
nasseri_esm@hotmail.com; esm_nasseri@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nila Ghanei
Position
PhD student
Other areas of specialty/work
Street address
National Nutrition and Food Technology Institute of IRAN. Shahid Beheshti University of Medical Sciences, West Arghavan, Farahzadi Blvd.
City
Tehran
Postal code
Phone
+98 21 2236 0656
Fax
Email
nillagh@yahoo.com; nilaghanei@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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