The effect of probiotic yogurt and conventional yogurt in control blood glucose and outcomes of pregnancy in women with gestational diabetes who were referred to Alzahra and Taleghani hospitals in tabriz
Design
A randomized clinical trial was conducted in two groups of control and intervention, blinded,84 patients using randomized tables in two intervention groups (probiotic yoghurt recipients) and control group (receiving yogurt recipient).
Settings and conduct
The double-blind, randomized clinical trial was carried out on diabetic patients who refered the diabetes clinic of Alzahra and Talegani hospital Tabriz, Iran. The type of received intervention will be will be written given on paper and will be numbered in matt envelopes.
Participants/Inclusion and exclusion criteria
Pregnant women 24-24 weeks of gestational diabetes mellitus will be included in the study and will not be included, if they have a history of diabetes in previous pregnancy or abnormal fetal
Intervention groups
The subjects in the intervention group consume 300 g/d probiotic yogurt containing 106 colony of both Lactobacillus acidophilus and Bifidobacterium lactis bacteria.(Production of the Iranian milk company Pegah) for 8 weeks
Subjects in the control group consume 300g/d conventional yogurt.
Main outcome variables
Hemoglobin A1c؛ Fasting Blood Sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121224011862N2
Registration date:2018-05-19, 1397/02/29
Registration timing:registered_while_recruiting
Last update:2018-05-19, 1397/02/29
Update count:0
Registration date
2018-05-19, 1397/02/29
Registrant information
Name
Farnaz Sahaf
Name of organization / entity
Women's Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
sahaf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-06, 1397/02/16
Expected recruitment end date
2019-07-07, 1398/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic yogurt and conventional yogurt in blood glucose control and outcomes of pregnancy in women with gestational diabetes
Public title
The effect of probiotic yogurt and conventional yogurt in controlblood glucose and outcomes of pregnancy in women with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women with gestational diabetes
Gestational age 24-28 weeks
singleton pregnancy
Provision of written informed consent
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Random block
Blinding (investigator's opinion)
Double blinded
Blinding description
Yoghurts will be delivered from the factory without specification insertion, encoded, and distributed between the two groups of 42 who received them without any knowledge
Placebo
Not 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
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2018-04-10, 1397/01/21
Ethics committee reference number
IR.TBZMED.REC.1397.013
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
Before and after 8 weeks
Method of measurement
Chromatography
2
Description
Fasting Blood Sugar
Timepoint
Befor and after 8 weeks
Method of measurement
spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
The subjects in the intervention group consume 300 g/d probiotic yogurt containing 106 colony of both Lactobacillus acidophilus and Bifidobacterium lactis bacteria.(Production of the Iranian milk company Pegah) for 8 weeks
Category
Treatment - Other
2
Description
Subjects in the control group consume 300g/d conventional yogurt.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
فرناز صحاف
Street address
Alzahra Hospital, South Artesh St
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
2
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Farnaz Sahaf
Street address
Taleghani hospital, Rah Ahan, Tabriz, East Azerbaijan Province
City
Tabriz
Province
East Azarbaijan
Postal code
34424882
Phone
+98 41 3442 4421
Email
lahroudin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
33357313
Phone
+98 41 3554 1221
Email
lahroudin@gmail.com
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
Dr.Farnaz Sahaf
Position
Associte proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793 41 1553
Phone
+98 41135539161
Email
lahroudin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farnaz Sahaf
Position
Associte proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 35519161
Email
lahroudin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Farnaz Sahaf
Position
Associte proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
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