Objectives: This study aims to determine the effect of probiotic yoghurt on constipation in pregnancy period. Design: Two parallel arm Randomized Controlled Trial. Setting and conduct: This study will be conducted in obstetrics clinic of Alzahra and Taleghani hospitals in Tabriz city. Eligible women will be randomly assigned into two groups of 30 subjects with block sizes of 4 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment. Participants including major eligibility criteria: 60 healthy pregnant women aged up to 18 years old who suffering from constipation. Interventions: The intervention group will receive probiotic yoghurt 100 grams daily in addition to advice about exercise, High-fiber diet and Magnesium hydroxide syrup. The control group will receive ordinary yoghurt 100 grams daily in addition to advice about exercise, High-fiber diet and Magnesium hydroxide syrup. Main outcome measures: The variables of frequency of bowel movements, straining during bowel movements, stool consistency, sensation of incomplete evacuation during defecation, feeling of blockage in the path of defecation, need to be manipulated to facilitate defecation and stool color will be assessed by the constipation questionnaire, respectively at one week before intervention and during the first, second, third, fourth and sixth weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070110324N18
Registration date:2014-12-30, 1393/10/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-30, 1393/10/09
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-03-30, 1394/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic yoghurt on constipation in pregnancy period: a double-blind randomized controlled trial.
Public title
The effect of probiotic yoghurt on constipation in pregnancy period
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy pregnant women who suffering from constipation; Up to 18 years old, Singleton pregnancy; Gestational age between 24-28; Having literacy; Willingness to participate in the study
Exclusion criteria: Receiving medication for constipation in less than a week before the study; Having brain problems (e.g. epilepsy) according to the individual expression; Having metabolic disease (hyporthyroidism), Hirschsprung's disease, spinal injuries, anorectal malformations, inflammatory bowel disease and pervious gastrointestinal surgery according to the individual expression; Using Fermented dairy products containing probiotics 2 weeks before the study; Use of antibiotics within 2 weeks prior to the study.
Age
From 18 years old to 49 years old
Gender
Female
Phase
2-3
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 Tabriz University of Medical Sciences
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
9343
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Frequency of bowel movements
Timepoint
A week before the intervention and within weeks of the first, second , third , fourth and sixth postintervention
Method of measurement
Constipation Questionnaire
2
Description
Straining during bowel movements
Timepoint
A week before the intervention and within weeks of the first, second , third , fourth and sixth postintervention
Method of measurement
Constipation Questionnaire
3
Description
Stool consistency
Timepoint
A week before the intervention and within weeks of the first, second , third , fourth and sixth postintervention
Method of measurement
Constipation Questionnaire
4
Description
Sensation of incomplete evacuation during defecation
Timepoint
A week before the intervention and within weeks of the first, second , third , fourth and sixth postintervention
Method of measurement
Constipation Questionnaire
5
Description
Feeling of blockage in the path of defecation
Timepoint
A week before the intervention and within weeks of the first, second , third , fourth and sixth postintervention
Method of measurement
Constipation Questionnaire
6
Description
Need to be manipulated to facilitate defecation
Timepoint
A week before the intervention and within weeks of the first, second , third , fourth and sixth postintervention
Method of measurement
Constipation Questionnaire
7
Description
Stool color
Timepoint
A week before the intervention and within weeks of the first, second , third , fourth and sixth postintervention
Method of measurement
Constipation Questionnaire
Secondary outcomes
1
Description
The first time of eliminating the symptoms and improvement in constipation
Timepoint
Before intervention, 1, 2 , 3, 4 and 6 weeks after intervention
Method of measurement
Questionnaire
2
Description
Quality of life score
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Quality of Life Questionnaire
3
Description
Side Effects
Timepoint
1, 2 , 3, 4 and 6 weeks after intervention
Method of measurement
Questionnaire
4
Description
Patients satisfaction from treatment
Timepoint
1, 2 , 3, 4 and 6 weeks after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group will receive probiotic yogurt 100 gram daily
Category
Treatment - Other
2
Description
The control group will receive ordinary yoghurt 100 grams daily.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospitals
Full name of responsible person
Kolsoum Shokri
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Kolsoum Shokri
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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, 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 Sciences
Full name of responsible person
Kolsoum Shokri Gezeljeh
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street