Objective: The aim of this study is to determine the effects of synbiotic supplementation on biomarkers of inflammation and oxidative stress in patients with gestational diabetes. Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with gestational diabetes aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate. 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. Intervention: Patients will be assigned into two groups to receive synbiotic (n=30) or placebo (n=30) per day. Synbiotic and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and end of the intervention: 6 weeks. Outcomes: Biomarkeres of inflammation and oxidative stress will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704205623N108
Registration date:2017-04-27, 1396/02/07
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-04-27, 1396/02/07
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of synbiotic supplementation compared with the placebo on pregnancy outcomes in women with gestational diabetes
Public title
Effect of supplementation therapy 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: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
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
Ethics committee of Iran University of Medical Sciences
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2016-04-18, 1395/01/30
Ethics committee reference number
IR.IUMS.REC.1395.9311290004
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
Newborn length
Timepoint
The first 24 h after birth
Method of measurement
Girth measuring tape
2
Description
Newborns' weight
Timepoint
The first 24 h after birth
Method of measurement
Scale
3
Description
Polyhydramnios
Timepoint
After the intervention
Method of measurement
Sonography
4
Description
Total antioxidant
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
Intervention groups
1
Description
Control group: Placebo oral capsule (Barij Essence, Kashan, Iran), daily, for 6 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Synbiotic oral 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), 0.8 g inulin, daily, for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Clinic
Full name of responsible person
Maryam Karamali
Street address
Akbarabadi Hospital, Mowlavi Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Vice chancellor for research, Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
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
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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)