Protocol summary
-
Study aim
-
The aim of this study is to determine the effects of probiotic supplementation on biomarkers of inflammation and oxidative stress in patients with gestational diabetes.
-
Design
-
Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
-
Settings and conduct
-
Population and sample size: Among patients with gestational diabetes referred to Akbarabadi Clinic affiliated to Iran University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Placenta abruption, pre-eclampsia, eclampsia, hypo and hyperthyroidism, urinary tract infection, smokers, kidney or liver diseases and insulin therapy during intervention
-
Intervention groups
-
Intervention: Patients will be assigned into two groups to receive probiotic (n=30) or placebo (n=30) per day. Probiotic and placebos capsules are similar in shape and size.
-
Main outcome variables
-
Outcomes: Inflammatory markers (primary outcomes), and biomarkers of oxidative stress and pregnancy outcomes (secondry outcomes) signaling pathway will be quantified at study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201611115623N91
Registration date:
2016-11-23, 1395/09/03
Registration timing:
retrospective
Last update:
2019-09-25, 1398/07/03
Update count:
1
-
Registration date
-
2016-11-23, 1395/09/03
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Iran University of Medical Sciences
-
Expected recruitment start date
-
2016-04-07, 1395/01/19
-
Expected recruitment end date
-
2016-05-08, 1395/02/19
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Clinical trial of the effect of probiotic supplementation compared with the placebo on pregnancy outcomes in women with gestational diabetes
-
Public title
-
Effect of supplementation in treatment of women with gestational diabetes
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients with gestational diabetes
Aged 18 to 40 years.
Exclusion criteria:
Placenta abruption
Pre-eclampsia
Eclampsia
Hypo and hyperthyroidism
Urinary tract infection
Smokers
Kidney or liver diseases
Insulin therapy during intervention
-
Age
-
From 18 years old to 40 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization will be done by the use of computer-generated random numbers.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-04-06, 1395/01/18
-
Ethics committee reference number
-
IR.IUMS.REC 1394.9111290001
Health conditions studied
1
-
Description of health condition studied
-
Gestational diabetes
-
ICD-10 code
-
E28.2
-
ICD-10 code description
-
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
-
Description
-
hs-CRP
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Elisa kit
2
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
Secondary outcomes
1
-
Description
-
Total antioxidant
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
2
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
3
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 6 weeks of intervention
-
Method of measurement
-
Spectrophotometry
4
-
Description
-
Newborns' weight
-
Timepoint
-
The first 24 h after birth
-
Method of measurement
-
Scale
5
-
Description
-
Newborns' length
-
Timepoint
-
The first 24 h after birth
-
Method of measurement
-
Girth measuring tape
6
-
Description
-
Newborns' head circumference
-
Timepoint
-
The first 24 h after birth
-
Method of measurement
-
Girth measuring tape
7
-
Description
-
Polyhydramnios
-
Timepoint
-
Post-intervention
-
Method of measurement
-
Sonography
8
-
Description
-
Newborn's head circumference
-
Timepoint
-
Delivery time
-
Method of measurement
-
Tape
9
-
Description
-
Newborn's bilirubin
-
Timepoint
-
Delivery time
-
Method of measurement
-
Enzymatic kit
10
-
Description
-
Apgar score
-
Timepoint
-
Delivery time
-
Method of measurement
-
Clinical observation
11
-
Description
-
Newborns' hypoglycemia
-
Timepoint
-
After delivery
-
Method of measurement
-
Enzymatic kit
12
-
Description
-
Preterm delivery
-
Timepoint
-
After delivery
-
Method of measurement
-
Medical record
13
-
Description
-
Maternal pre-eclampsia
-
Timepoint
-
After delivery
-
Method of measurement
-
Medical record
14
-
Description
-
Newborns' hospitalization
-
Timepoint
-
After delivery
-
Method of measurement
-
Medical record
Intervention groups
1
-
Description
-
Intervention group: Probiotic capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (Tak Gen Zist, Tehran, Iran), daily, for 6 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo (Tak Gen Zist, Tehran, Iran), daily, for 6 weeks orally.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Vice chancellor for research, Iran 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
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