Protocol summary

Study aim
Determination and comparison of the effect of Laxaplus and Polyethylene Glycol powder 4000 in the treatment of constipation in patients 2 to 15 years old
Design
A simple randomized clinical trial (not blinded) using simple random table (phase 3), with control group (parallel groups) that 60 patients with functional constipation are randomly allocated to 2 groups (Intervention and control groups).
Settings and conduct
60 patients aged 2 to 15 years old referred to Imam Hossein Hospital, whose functional constipation was confirmed by Rome 4 criteria, (after obtaining written consent) are randomly allocated to 2 groups (receiving Laxaplus 1 cc/kg daily divided in 3 times, in the children with body weight less than 30 kg and 10 cc 3 times daily, in body weight more than 30 kg orally half an hour before meals and receiving PEG (4000) Powder 0.7 gr/kg 3 times daily). Both groups will be evaluated for 8 weeks after intervention. (Not blinded)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Functional constipation confirmed by ROME 4 criteria; Exclusion criteria: Patients with stractural causes of constipation; chronic illness who need special care; History of the gastrointestinal tract surgery except for appendectomy; allergy or drug sensitivity; Autism and major psychotic disorders;Using some drugs; Weight loss more than 5 percent in the past 3 months; Using drugs that have an unknown effect on the GI tract.
Intervention groups
Intervention group: Laxaplus 1cc/kg daily divided in 3 times , in the children with body weight less than 30 kg and 10 cc 3 times daily, in the children with body weight more than 30 kg orally half an hour before meals for 8 weeks; Control group: PEG(4000)Powder 0.7 g /kg orally 3 times daily for 8 weeks.
Main outcome variables
Constipation improvement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190410043224N3
Registration date: 2020-06-21, 1399/04/01
Registration timing: registered_while_recruiting

Last update: 2020-06-21, 1399/04/01
Update count: 0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
Peiman Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 6331
Email address
peiman.nasri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation between the laxa plus barij and Polyethylene glycol (4000) in the pediatric functional constipation in chidren 2 to 15 years old
Public title
Comparison between the laxa plus barij and Polyethylene glycol in the pediatric constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Functional constipation confirmed by ROME 4 criteria Defecation twice a week or less; History of stool retention; history of painful defecation; History of large stool diameter; History of large stool mass in rectum;
Exclusion criteria:
Patients with stractural causes of constipation such as celiac disease; pseudo-obstruction; hypothyroidism; spina bifida, anorectal malformation; hirschsprung's disease; Patients with chronic illness who need special care such as: renal stone; sickle cell anemia; cerebral palsy; hepatitis; hematologic diseases; gastrointestinal bleeding; recurrent fever or fever without locolized sign; Pregnanccy; History of gastrointestinal tract surgery exept for appendectomy; History of allergy or Drug sensitivity; autism; major psychotic disorder such as bipolar disorder; schizophrenia; Children who had experienced physical abuse and sexual abuse; Use of medication such as Metoclopramide, Erythromycin, Bethanechol, CoAmoxiclav, Azithromycin, Domperidone, Amitriptyline, Hyoscyamine, Clonidine, Baclofen, Dicyclomine, Scopolamine; Weight loss more than five percent in the past three monthes; Using drugs that have an unknown effect on the gastrointestinal tract
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
The samples are selected among the target community according to the entry and exit criteria by convenience non probability method ,then they are randomly allocated into intervention and control groups by Random allocation software developed by Dr.Mahmoud Saghaei.
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
Ethics committee of Esfahan University of Medical Sciences
Street address
Imam Khomeini/ children hospital Imam hossein
City
Esfahan
Province
Isfehan
Postal code
8195163381
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.MUI.MED.REC.1399.082

Health conditions studied

1

Description of health condition studied
Functional constipation
ICD-10 code
K59.09
ICD-10 code description
Other constipation

Primary outcomes

1

Description
Constipation improvement
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Clinical Examination; Questionnaire of Constipation Evaluation

Secondary outcomes

1

Description
Treatment side effects
Timepoint
During the study and 8 weeks after the intervention
Method of measurement
Clinical Examination; Questionnaire of Constipation Evaluation

Intervention groups

1

Description
Intervention group: Laxa plus barij 1cc/kg daily divided in 3 times ,in the children with body weight less than 30 kg and 10cc 3 times daily,in the children with body weight more than 30 kg orally half an hour before meals for 8 weeks
Category
Treatment - Drugs

2

Description
Control group: Polyethylene glycol (4000) Powder (Sepidaj Pharmaceutical Company) 0.7 g / kg orally three times daily for eight weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hosein Children's Hospital
Full name of responsible person
Nasri Peiman
Street address
Imam Hosein Children's Hospital, Imam Khomeini Ave
City
ISFAHAN
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Email
peiman94157@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Research and Technology Deputy of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3061
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Barij Medicinal Plant Research Center
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shima Saeidi
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
shimasaeidi369@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Peiman Nasri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan City
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Peiman94157@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Peiman Nasri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Hossein Hospital, Imam Khomeini Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
Peiman94157@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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