Protocol summary

Study aim
Effect of oral probiotic lactofem on metabolic parameters in overweight pregnant women referred to prenatal clinics of the shiraz hospitals in 2016
Design
Effect of oral probiotic capsules Lactofem on metabolic parameters: this research is a double blinded placebo-controlled trial. fasting glucose, lipid profiles, diastolic and systolic blood pressure in pregnant women 18 to 35 years who were overweight and at weeks 16 and 20 of pregnancy on the basis of the questionnaire and randomly selected configuration block design is divided into two groups: placebo and intervention. Each group of 64 people divided into two lactofem capsules daily or placebo until the end of pregnancy. the intervention done at 20 weeks and at the end of 28 weeks and 36 weeks of pregnancy, systolic and diastolic blood pressure and fasting blood samples to assess the lipid profile and glucose, and samples blood sugar 2 hours after breakfast, evaluating.Data evaluation done with placebo and intervention groups then results will be compared with statistical methods.
Settings and conduct
This study is an interventional study of double-blind, controlled clinical trial that studied the effect of lactobacillus probiotic capsule on metabolic parameters of overweight Pregnant women.This research is done in selected hospitals in Shiraz.
Participants/Inclusion and exclusion criteria
Pregnant women aged 18 to 35 years and the gestational age of 20 to 24 weeks, with a BMI of over 25, If they have criteria for entering the study, they will be selected.
Intervention groups
An interventional study is a double-blind clinical controlled trial in which to study the effect of lactofem probiotic capsule on Metabolic Indicators of Overweight Pregnant Women in two groups, oral probiotic capsule (test) and placebo (control) are checked.
Main outcome variables
Comparison of fasting blood sugar level before intervention at 20 weeks, and after the intervention at weeks 28 and 36 pregnancy in in test and control groups. Comparison of 2hpp level before intervention at 20 weeks, and after the intervention at weeks 28 and 36 pregnancy in in test and control groups. Comparison of mean lipid profile before intervention at 20 weeks, and after the intervention at weeks 28 and 36 pregnancy in in test and control groups. Comparison of systolic and diastolic blood pressure, before intervention at 20 weeks, and after the intervention at weeks 28 and 36 pregnancy in in test and control groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161025030502N2
Registration date: 2018-02-04, 1396/11/15
Registration timing: retrospective

Last update: 2018-02-04, 1396/11/15
Update count: 0
Registration date
2018-02-04, 1396/11/15
Registrant information
Name
Elnaz Gharib
Name of organization / entity
School of Nursing and Midwifery, Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 32357764
Email address
stud2452166723@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical science budget
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-01-20, 1395/11/01
Trial completion date
empty
Scientific title
Effect of oral probiotic lactofem on metabolic parameters in overweight pregnant women referred to prenatal clinics of the shiraz hospitals in 2016
Public title
Effect of oral probiotic lactofem on metabolic parameters in overweight pregnant women referred to prenatal clinics of the shiraz hospitals in 2016
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to participate in research pre-pregnancy body mass index between 25 > BMI> 30 (which is selected by questionnaire) 20 to 24 weeks gestational age The lack of any disease, including diabetes, high blood pressure, liver disease, kidney, adrenal and thyroid, Hypercholesterolemia and bleeding Do not use medications that affect glucose metabolism and fat and blood pressure normal diet (based on questionnaires is selected) non-smoking
Exclusion criteria:
No proper use of probiotics any allergies to medication or placebo The occurrence of acute bleeding pre-eclampsia
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 144
Actual sample size reached: 144
Randomization (investigator's opinion)
Randomized
Randomization description
A permutation block design will be used after selecting each sample, we assign it to the treatments B, A using the random numbers table. Let's put the number from 0 to 4 in AB's permutation, and 5 to 9 in the BA reversal.
Blinding (investigator's opinion)
Double blinded
Blinding description
Probiotics are given blindly. probiotic capsule and placebo are completely prepared by the pharmaceutical company. After encoding, they are randomly assigned to groups a and b. After completing sampling and collecting information, the group code is given to the researcher. At the beginning of the study, the patient is described as being in the A or B group Which may include oral probiotic capsules or placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz - Zand Street - Next to the Red Crescent - Sakhtmtn Central University - Class 7 - Research Shiraz
City
Shiraz
Province
Fars
Postal code
1978 -71345
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.SUMS.REC.1395.126

Health conditions studied

1

Description of health condition studied
Certain conditions originating in the perinatal period
ICD-10 code
P96.8
ICD-10 code description
Other specified conditions originating in the perinatal period

Primary outcomes

1

Description
Fasting blood sugar-Fasting glucose and blood sugar 2 hours after breakfast
Timepoint
20 week before intervention,28 and 36 week, after intervention
Method of measurement
Blood sample

2

Description
systolic and diastolic blood pressure
Timepoint
20 week before intervention,28 and 36 week, after intervention
Method of measurement
Blood sample

3

Description
plasma lipids
Timepoint
20 week before intervention,28 and 36 week, after intervention
Method of measurement
Blood sample

Secondary outcomes

1

Description
Reduce the blood sugar
Timepoint
20 week before intervention,28 -36 week after intervention
Method of measurement
نمونه خون

2

Description
Reduce the blood pressure
Timepoint
20 week before intervention,28 -36 week after intervention
Method of measurement
mercury manometer

3

Description
Reduce the serum lipids
Timepoint
20 week before intervention,28 -36 week after intervention
Method of measurement
نمونه خون

Intervention groups

1

Description
In the intervention group one probiotic capsule every 12 hours be administered Of the week 20 to 36 of pregnancy.
Category
Prevention

2

Description
Case-control study. In the control group one placebo capsule every 12 hours be administered Of the week 20 to 36 of pregnancy.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Hafez hospital
Full name of responsible person
ِDr. Fateme Poordast
Street address
School of medicine, Emam hossein square, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 21 3230 5645
Email
ta.poordast@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vice President of Research Shiraz University of Medical Siences-Dr.Hashemi Basir
Street address
7th floor,Central building of Shira Universityof Medical Siences,Next to the Red Crescen ,Zand Street
City
Shiraz
Province
Fars
Postal code
71345- 1978
Phone
+98 71 3212 2389
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
School of Nursing and Midwifery, Shiraz University of Medical Siences
Full name of responsible person
Sara Azima
Position
Masters of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Namazi Squar,Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 917 300 9450
Fax
Email
azimas@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
school of Nursing and Medwifery, Shiraz University
Full name of responsible person
Sara Azima
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Street address
Namazi Squar,Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
Email
azimas@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The School of Nursing and Midwifery of Shiraz
Full name of responsible person
Elnaz Gharib
Position
Master student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
West Moshir street, Shiraz
City
Shiraz
Province
Fars
Postal code
7133618176
Phone
+98 71 3235 7764
Fax
Email
elnazgharib5932@gmail.com
Web page address

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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