This study aimed to investigate the therapeutic effect of probiotic Bacillus Plyatylnglykvl and Prhbyvtyk Kvagvlans and Bifidobacterium probiotics is designed to stimulate growth.
In this double blind clinical trial , 120 children 2-16 years old with functional chronic constipation referred to Amir Kabir hospital of Arak according to inclusion criteria : no other cell disease and exclusion criteria : children with a diagnosis of IBS ; mentally retarded children or metabolic disease , or spinal anomalies in children with Hirschsprung's disease or anorectal pathology , children with a history of stomach or intestinal surgery were enrolled and received at least 2-3 days to constipation enema liquid paraffin as the primary fixed and randomly divided into three groups ethylene Polyphlore glycol + placebo (n = 40 ) , and the prebiotics + placebo (n = 40 ) and polyethylene glycol (PEG) + probiotic (n = 40 ) at a dose of gr / kg / day 7/0 are divided .Treatment will continue for 6 weeks. Defecation frequency per week, stool consistency, frequency of having abdominal pain and painful defecation, constipation side effects such as nausea and vomiting, headache baseline and after it is recorded. These variables as well as possible side effects of drugs used in the study and treatment success rates are compared between the three groups before and after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112415511N1
Registration date:2013-12-13, 1392/09/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-13, 1392/09/22
Registrant information
Name
Dr. Mojtaba Hashemi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 863134719
Email address
s.hashemi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Arak University of Medical Sciences
Expected recruitment start date
2013-08-21, 1392/05/30
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeotic effect of probiotic with PEG in children functional constipation.
Public title
Comparison of therapeotic effect of probiotic with PEG in children functional constipation.
Purpose
Treatment
Inclusion/Exclusion criteria
nclusion criteria: children 2-16 years of age with chronic functional constipation associated with any disease.Exclusion criteria: Children diagnosed with IBS criteria ROME III;Treatment of constipation in the two weeks prior to study entry; Children with mental retardation or metabolic diseases (eg, hypothyroidism); Children with Hirschsprung's disease or anorectal anomalies injury or pathology; Children with a history of stomach or intestinal surgery; Children under medical treatment affecting the GI such as cisapride; Motilium, erythromycin and loperamide
Age
From 2 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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 Medical Sciences
Street address
Hoda Elm Street, Amirkabir, Arak
City
Arak
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
14- 151 - 92
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Defecation frequency per week
Timepoint
Baseline and then
Method of measurement
Questionnaire
2
Description
Stool consistency
Timepoint
Baseline and then
Method of measurement
Questionnaire
3
Description
Read Ndad having abdominal pain and painful defecation
Timepoint
Baseline and then
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Headache
Timepoint
Baseline and then
Method of measurement
Checklist
2
Description
Nausea and vomiting
Timepoint
Baseline and then
Method of measurement
Checklist
Intervention groups
1
Description
Group 1: Polyethylene glycol (PEG) + placebo (n = 40)
Category
Placebo
2
Description
Group 2: Probiotic + placebo (n = 40)
Category
Treatment - Drugs
3
Description
Group 3: polyethylene glycol (PEG) + probiotic (40)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital Arak
Full name of responsible person
Dr. Hashemi Mojtaba
Street address
Aamirkabir hospital - arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Hekmatpoo Davood
Street address
Hoda Elm Street, Hospital Amirkabir, 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
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marjan Habibi
Position
Resident of General Pediatric Diseases
Other areas of specialty/work
Street address
Hoda Elm Street, Hospital Amirkabir, Arak
City
Arak
Postal code
Phone
+86 33134716
Fax
Email
mary_jane612000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojtaba Hashemi
Position
Specialty of Pediatric Cardiology
Other areas of specialty/work
Street address
Amirkabir Hospital- Hoda elm street- Arak
City
Arak
Postal code
Phone
+98 86 3313 4716
Fax
Email
mojtaba53hashemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Marjan Habibi
Position
Resident of General Pediatric Diseases
Other areas of specialty/work
Street address
Hoda Elm Street,Hospital Amirkabir, Arak
City
Arak
Postal code
Phone
+86 33134716
Fax
Email
mary_jane612000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)