Evaluating The Effects of Lactobacillus Sporogenes in Combination with Mineral Oil Compared with Mineral Oil Alone on Symptoms of Constipation in Children aged 2 to 15 Years with Functional Constipation
We aimed to evaluate the effects of a Probiotic containing Lactobacillus Sporogenes in combination with mineral oil compared with mineral oil alone on symptoms of constipation in children. This controlled trial was conducted in 2010-2011 in Isfahan on 60 children (aged 2 to 15 years) with functional constipation (based on the Rome III criteria) referred to a pediatric gastroenterology clinic. Those with immunocompromised conditions and those receiving antibiotics were not included. Children randomly (based on random table numbers) received the Probiotic (Lactol®, composed of Lactobacillus Sporogenes, 1 Tab/20kg/d) plus mineral oil (Paraffin 1 ml/kg/d) or the mineral oil alone (Paraffin 1 ml/kg/d) for two months. Symptoms of constipation were the primary measures including defecation frequency, stool form, strain and pain at defecation, incomplete evacuation and soiling which were assessed by the Rome III questionnaire and compared before and 2 months after the intervention. After the treatment period, the two groups were also compared with regards to global improvement as the secondary measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207311579N1
Registration date:2012-09-11, 1391/06/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-11, 1391/06/21
Registrant information
Name
Ali Gholamrezaei
Name of organization / entity
Medical Students' Research Center, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 8675
Email address
gholamrezaei@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Islamic Azad University, Najafabad Branch
Expected recruitment start date
2010-01-05, 1388/10/15
Expected recruitment end date
2011-02-04, 1389/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating The Effects of Lactobacillus Sporogenes in Combination with Mineral Oil Compared with Mineral Oil Alone on Symptoms of Constipation in Children aged 2 to 15 Years with Functional Constipation
Public title
Efficacy of Probiotic in the Treatment of Childhood Functional Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1- Children 2 to 15 years of age,
2- Having functional constipation based on the Rome III criteria,
3- Parents' Consent for Participation.
Exclusion Criteria:
1- Those with immunocompromised condition or other severe diseases,
2- Those receiving antibiotic in the previous four weeks,
3- Experiencing severe side effects, gastroenteritis, or receiving antibiotic for any reason during the study period.
Age
From 2 years old to 15 years old
Gender
Both
Phase
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Islamic Azad University, Najafabad Branch
Street address
University Ave.
City
Najafabad
Postal code
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
150101018772055
Health conditions studied
1
Description of health condition studied
Childhood Functional Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Symptoms of constipation
Timepoint
Before and 2 months after treatment
Method of measurement
Rome III questionnaire
Secondary outcomes
1
Description
Global improvement
Timepoint
Two months after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Controls:
Mineral oil (Paraffin 1 ml/kg/d) for 8 weeks
Category
Treatment - Drugs
2
Description
All children:
Toilet training and dietary advices
Category
Behavior
3
Description
Intervention:
Synbiotic (Lactol®, Bioplus Life Sciences Pvt. 1 Tab/20kg/d) plus mineral oil (Paraffin 1 ml/kg/d) for 8 weeks.
The synbiotic used in this study composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Dr. Hossein Saneian
Street address
Department of Pediatric Gastroenterology, Alzahra University Hospital, Soffeh Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University, Najafabad Branch
Full name of responsible person
Dr. Reza Ebrahimi
Street address
University Ave.
City
Najafabad
Grant name
بررسي اثر سين بيوتيك در درمان يبوست فانكشنال كودكان مراجعه کننده به بیمارستان الزهرا (س) اصفهان سال 1388-1389
Grant code / Reference number
15010101872055
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Islamic Azad University, Najafabad Branch
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
Medical Students' Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ali Gholamrezaei
Position
MD, Research Assistant
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 1669 8675
Fax
+98 31 1668 0168
Email
ali.gholamrezaei.63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Hossein Saneian
Position
MD, Associate Prof. Pediatric Gastroenterology
Other areas of specialty/work
Street address
Department of Pediatrics, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
+98 31 1668 0168
Email
saneian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Students' Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ali Gholamrezaei
Position
MD, Research Assistant
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 1669 8675
Fax
+98 31 1668 0168
Email
ali.gholamrezaei.63@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)