Protocol summary

Summary
The aim of this randomized controlled trial is to determine the effect of probiotic yoghurt (containing Lactobacillus Acidophilus LA5 and Bifidobacterium Lactis BB12) on maternal blood glucose (primary outcome), as well as maternal and neonatal outcomes (secondary outcomes). After signing written informed consent, 130 pregnant women at about 20 weeks of gestation, covered by health center in Tabriz-Iran, with BMI≥25 and normal fasting blood sugar level will be recruited and allocated into two groups using stratified (overweight or obese) block randomization with allocation ratio of 1:1. Consequently numbered opaque sealed envelopes containing a paper with a unique group code will be used to conceal the allocation. The allocation sequence and envelops will be prepared by a person not involved in data collection. Participants will be asked not to consume any probiotic products for two weeks and consume 100 g probiotic or placebo yogurt daily, identified with the group code, from 24th weeks of gestation until delivery. At 28 weeks of pregnancy, fasting blood glucose and glucose tolerance test; at 37 weeks of pregnancy, medical complications like preterm delivery, preeclampsia, as well as maternal physical activity; and following delivery, maternal (preterm delivery, preeclampsia, pregnancy weight gain and gestational diabetes) and neonatal (birth weight, hyperbilirubinemia and neonatal death) outcomes will be examined. Compliance rate, satisfaction and side effects of probiotics will also be determined.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604013706N31
Registration date: 2016-04-12, 1395/01/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-04-12, 1395/01/24
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2016-11-10, 1395/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic yoghurt on level of blood glucose in obese and overweight pregnant women: a randomized controlled trial
Public title
Effect of probiotic yoghurt on level of blood glucose in obese and overweight pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 20-22 weeks of pregnancy; FBS<92 mg/dl; BMI≥25; age≥ 18 years; able to read and write Exclusion criteria: multiple pregnancy; prior history of GDM; taking any medication likely to influence metabolism of glucose (in particular metformin, glucocorticoids or immunosuppressants); medical condition associated with altered glucose metabolism (in particular Cushing's syndrom/disease and hepatic cirrhosis); known major fetal abnormality; known regular ingestion of other probiotics; smoking; antibiotic intake during current pregnancy
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 130
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
Research deputy of Tabriz University of Medical Sciences
Street address
3rd floor, Centeral Building No 2, Tabriz University of Medical Science, Golgasht st., Tabriz
City
Tabriz
Postal code
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
TBZMED.REC.1394.1208

Health conditions studied

1

Description of health condition studied
impaired blood glucose
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test

Primary outcomes

1

Description
Fasting blood glucose
Timepoint
Before the intervention, 4 weeks after intervention
Method of measurement
labratory assessment

2

Description
blood glucose level 1 hour after intaking 75g oral glucose
Timepoint
4 weeks after intervention
Method of measurement
labratory assessment

3

Description
blood glucose level 2 hours after intaking 75g oral glucose
Timepoint
4 weeks after intervention
Method of measurement
labratory assessment

Secondary outcomes

1

Description
Gestational diabetes
Timepoint
4 weeks after intervention and after delivery
Method of measurement
Labratory Assessment

2

Description
Peeclampsia
Timepoint
37th weeks of pregnancy and after delivery
Method of measurement
clinical (blood preassure) & labratory (proteinuria) assessment

3

Description
Preterm delivery
Timepoint
after delivery
Method of measurement
medical record assessment

4

Description
Birth weight
Timepoint
at birth, 10 days after birth
Method of measurement
medical record assessment, measurment of weight 10-12 days after birth by the researcher

5

Description
Macrosomia or Large for gestational age
Timepoint
after delivery
Method of measurement
based on birth weight

6

Description
Neonatal death
Timepoint
30 days after birth
Method of measurement
asking from participant (woman) via calling

7

Description
Neonatal billirubine level
Timepoint
3-5 days after delivery
Method of measurement
labratory assessment

Intervention groups

1

Description
Intervention group: Probiotic yogurt (containing 109 Cfu Lactobacillus Acidophilus LA5 and Bifidobacterium Lactis BB12), 100g daily, from 24th weeks of gestation until delivery
Category
Prevention

2

Description
Control group: conventional yogurt, 100g daily, from 24th weeks of gestation until delivery
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers
Full name of responsible person
Hanieh Asgharian
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad-Reza Rashidi
Street address
Research Deputy, 3rd floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht st., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz 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
Nursing & Midwifery Faculty, Tabriz University of medical science
Full name of responsible person
Hanieh Asgharian
Position
MSc student in midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South shariatie Ave
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6969
Fax
Email
haniehasgh1367@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South shariati street,Tabriz
City
Tabriz
Postal code
5138947977
Phone
+98 414796969
Fax
Email
alizades@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing & Midwifery, Tabriz University of Medical Science
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6969
Fax
alizades@tbzmed.ac.ir
Email
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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