Comparison the effects of Psyllium seed husk powder Vs. Polyethylene glycol with and without probiotics in functional constipation of 2 to 10 year-old children
Objective: To compare the effects of Psyllium vs Polyethylene glycol with and without probiotics in pediatric functional constipation. Study design: Parallel triple-blind randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Two to ten-year-old children with functional constipation, diagnosed based on the ROME III criteria, refered to children's clinic of Shahid Beheshti hospital. Exclusion criteria: Children beyond 2 and over 10 years old; use of other drugs that can cause constipation or diarrhea; or history of using pidrolax and probiotic in the last year. The subjects of the study: Children refered to children's clinic of Shahid Beheshti hospital. The sample size: 160 subjects will be divided into four groups of 40. The study duration: July 2017 to July 2018. Intervention of the study: Patients after receiving testimonial from their parents will be divided into 4 groups. Group one will receive polyethylene glycol, group two polyethylene glycol with probiotics, group three Psyllium and group four Psyllium with probiotics, all manufactured in the same sachets by Takgene zist company, 0.7 gr/kg in the form of water solution daily for 8 weeks. The patients will be fallowed up for 8 weeks. Primary outcomes: Assessing response to treatment with filling ROME III criteria based questionnaire by parents after 8 weeks of intervention, including frequency of defecation, defecation without pain and hardness, frequency of incontinence and drug admission in four groups. Secondary outcomes: Early relapse of constipation, according to ROME III criteria, after the end of intervention by filling the questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021112437N1
Registration date:2017-08-25, 1396/06/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-25, 1396/06/03
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh-m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Takgene zist pharmacy company
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of Psyllium seed husk powder Vs. Polyethylene glycol with and without probiotics in functional constipation of 2 to 10 year-old children
Public title
Effects of Psyllium seed husk powder vs. Polyethylene glycol on constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Two to ten years old children who refer to children's clinic of Shahid Beheshti hospital with functional constipation, diagnosed based on the ROME III criteria. Exclusion criteria: Children beyond 2 and over 10 years old; use of other drugs that can cause constipation or diarrhea; or history of using pidrolax and probiotic in the last year.
Age
From 2 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Study design: Parallel triple-blind randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2017-01-18, 1395/10/29
Ethics committee reference number
IR.KAUMS.REC.1395.113
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
k59.0
ICD-10 code description
Other functional intestinal disordes
Primary outcomes
1
Description
Defecation frequency
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Recorded through questionnaires filled by parents
2
Description
Defecation without pain
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Recorded through questionnaires filled by parents
3
Description
Drug admission
Timepoint
8 weeks after intervention
Method of measurement
Recorded through questionnaires filled by parents
4
Description
Defecation incontinency
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Recorded through questionnaires filled by parents
5
Description
Adverse effects of drugs
Timepoint
8 weeks after intervention
Method of measurement
Recorded through questionnaires filled by parents
Secondary outcomes
1
Description
Early constipation relapse discontinue medication
Timepoint
4 weeks after end of treatment
Method of measurement
Questionnaire that filling with parents
Intervention groups
1
Description
Intervention group 1: This group will receive one 7 gr sachet of polyethylene glycol, manufactured by Takgene zist, 0.7 gr/kg/day soled in 150 cc water, orally, for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: This group will receive one 7 gr sachet of polyethylene glycol with probiotics, manufactured by Takgene zist, 0.7 gr/kg/day soled in 150 cc water, orally, for 8 weeks.
Category
Treatment - Drugs
3
Description
Intervention group 3: This group will receive one 7 gr sachet of Psyllium, manufactured by Takgene zist, 0.7 gr/kg/day soled in 150 cc water, orally, for 8 weeks.
Category
Treatment - Drugs
4
Description
Intervention group 4: This group will receive one 7 gr sachet of Psyllium with probiotics, manufactured by Takgene zist, 0.7 gr/kg/day soled in 150 cc water, orally, for 8 weeks.