Effects of probiotic supplementation on preventing abortion,inflammatory factors and biomarkers of oxidative stress in women with spontaneously abortion history
Objective: The aim of this study is to determine the effects of probiotic supplementation on preventing abortion, inflammatory factors and biomarkers of oxidative stress in pregnant women with spontaneously abortion. Study design: Double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with spontaneously abortion will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with spontaneously abortion among pregnant women of eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either probiotic supplement containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei(2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (intervention group: n=30) or placebo (control group: n=30). Aborthion rate will be determined after 16-wk intervention. Fasting blood samples will be taken at baseline and after 16-wk intervention to measure inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 16 weeks (March 20, 2015-July 21, 2015). Outcomes: Inflammatory factors and biomarkers of oxidative stress will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503035623N38
Registration date:2015-03-10, 1393/12/19
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-03-10, 1393/12/19
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
Arak University of Medical Sciences
Expected recruitment start date
2015-03-14, 1393/12/23
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic supplementation on preventing abortion,inflammatory factors and biomarkers of oxidative stress in women with spontaneously abortion history
Public title
Effect of probiotic in the prevention of spontaneously abortion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women aged 18-40 years; diagnosed with spontaneously abortion.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with pre-eclampsia; complete bed rest (CBR); intra uterine fetal death (IUFD); placenta abruption; preterm delivery.
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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Postal code
Approval date
2014-09-08, 1393/06/17
Ethics committee reference number
19-167-93
Health conditions studied
1
Description of health condition studied
Spontaneously abortion
ICD-10 code
N96
ICD-10 code description
Habitual aborter
Primary outcomes
1
Description
Abortion rate
Timepoint
20 weeks of gestation
Method of measurement
Sonography
2
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
3
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
4
Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
5
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Probiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei(2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 16 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule, daily, for 16 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kossar Clinic
Full name of responsible person
Mehri Jamilian
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, 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
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
City
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)