Protocol summary

Summary
Abstract : The purpose was to compare the effect of probiotic with polyethylene glycol and polyethylene glycol alone for the treatment of functional constipation in children. Design: In this study children with functional constipation randomly allocated into two groups. To the first group was given polyethylene glycol and second group was given probiotic and polyethylene glycol. After 6 weeks, probiotic was added to group1 and removed from group2 medication. The study fallowed for more six weeks. The results of 4th week were compared with 1th week, and the results of 10th week were compared with 7th week in each groups. The data of 4th and 10th weeks were also compared between both groups. How do: Number of 80 children with functional constipation were enrolled in the study (40 for each group). Before treatment, basic information (stool frequency, stool consistency, fecal incontinence, abdominal pain, pain during defecation) were recorded. During the study, daily symptoms were recorded by the standard form. The data collected during the study were analyzed by SPSS software. Participants including major eligibility criteria: Inclusion criteria: children with functional constipation (Rome III criteria) Exclusion criteria: use of other medication for functional constipation except polyethylene glycol in 1 last month; The presence of organic cause; Dissatisfaction of parents or Patient Intervention: Use of probiotic of Bacillus Coagulans as adjuvant treatment of functional constipation by adding to polyethylene glycol The main outcome variable: The mean stool frequency, stool consistency, fecal incontinence, abdominal pain, pain during defecation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812222434N3
Registration date: 2015-05-10, 1394/02/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Mohammad Hadi Imanieh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4298
Email address
imaniehm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research shiraz university of medical sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-04-17, 1393/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between effect polyethylene glycol (PEG) Along with Bacillus coagulans (probiotic) with effect polyethylene glycol (PEG) in treatment of functional constipation in Childrens referred to pediatric gastroenterology clinic of Shiraz University of Medical Sciences
Public title
Comparison of effect of probiotic with polyethylene glycol,with polyethylene glycol alone in the treatment of functional constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:All pediatric patient with constipation that fulfilled Rome III criteria for functional constipation without any treatment;All pediatric patient with constipation that fulfilled Rome III criteria for functional constipation without clinical response to polyethylene glycol (PEG) Exclusion criteria:patients received other drugs for constipation except polyethylene glycol (PEG); The presence of organic cause; Dissatisfaction of parents or Patient
Age
From 1 month old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Medical Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences(central building), Zand Street, Shiraz, Fars
City
Shiraz
Postal code
Approval date
2013-09-28, 1392/07/06
Ethics committee reference number
ct-p-9355-5585

Health conditions studied

1

Description of health condition studied
constipation
ICD-10 code
k59.0
ICD-10 code description
Retention,retained-fecal

Primary outcomes

1

Description
stool frequency
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recorded through questionnaires

2

Description
stool incontinence
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recorded through questionnaires

3

Description
stool consistency
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recorded through questionnaires

4

Description
abdominal pain
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recorded through questionnaires

5

Description
pain on defecation
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recorded through questionnaires

Secondary outcomes

1

Description
drug adverse effects and clinical response
Timepoint
6th week and 12th week
Method of measurement
recoded through questionnaires

2

Description
Evaluation of Clinical response on stool frequency
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recoded through questionnaires

3

Description
Evaluation of Clinical response on Fecal incontinence
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recoded through questionnaires

4

Description
Evaluation of Clinical response on stool Consistency
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recoded through questionnaires

5

Description
Evaluation of clinical response of pain during defecation
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recoded through questionnaires

6

Description
Evaluation of Clinical response on abdominal pain
Timepoint
1th week.4thweek.7thweek and 10th week
Method of measurement
recoded through questionnaires

Intervention groups

1

Description
PEG solution 40% : 0.5gr/kg/dose TID Cap probiotic: 1.5*109 CFU TID
Category
Treatment - Drugs

2

Description
PEG solution 40% : 0.5gr/kg/dose TID for 6 week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pediatric GI clinic, Imam Reza clinic
Full name of responsible person
Ali keshtkari
Street address
Imam Reza clinic, Namazi Square, Zand street, Shiraz, Fars
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, vice chancellor for research
Full name of responsible person
Dr Basir Hashemi
Street address
Shiraz university of medical sciences(central building), Zand Street, Shiraz, Fars
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, vice chancellor for research
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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Keshtkari
Position
Fellowship of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Pediatric GI ward, Nammazi Hospital, Shiraz, Fars
City
Shiraz
Postal code
Phone
00
Fax
Email
keshtkari@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadi Imanieh
Position
Professor of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Pediatric GI ward, Department of Pediatric, Nammazi Hospital, Shiraz, Fars
City
Shiraz
Postal code
Phone
+98 71136474298
Fax
Email
imaniehm@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Keshtkari
Position
Fellowship of Pediatric Gastroenterology
Other areas of specialty/work
Street address
Pediatric GI ward, Nammazi Hospital, Shiraz, Fars
City
Shiraz
Postal code
Phone
00
Fax
Email
keshtkari@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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