Other diseases of intestines. Constipation
Conditions
Interventions
Intervention 1: 1.5 ml/kg/day oral liquid paraffin plus placebo (placebo sachet with the same shape and color to synbiotic). Intervention 2: 1 sachet of synbiotic per day (Restore 1 billion CFU/1 sach
Treatment - Drugs
1.5 ml/kg/day oral liquid paraffin plus placebo (placebo sachet with the same shape and color to synbiotic)
1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L.
1.5 ml/kg/day oral liquid paraffin and 1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. r
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
4 Years to 12 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age 4-12 years, diagnosis based on Room III criteria as two months of at least 2 or more of the following: less than 2 defecation in the toilet per week, more than 1 episode of fecal incontinence per week, history of retentive posturing or excessive volitional stool retention, history of painful or hard bowel movements, presence of a large fecal mass in the rectum, history of large diameter stools that may obstruct the toilet. Exclusion criteria: presence of organic causes for constipation; including Hirschsprung’s disease, spina bifida occulta, hypothyroidism, cystic fibrosis, neurologic abnormalities and intestinal pseudo-obstruction
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of bowel movements per week. Timepoint: 4 weeks. Method of measurement: Questionnarie.;Stool consistency. Timepoint: 4 Weeks. Method of measurement: Questionnarie.;Frequency of stool incontinence per week. Timepoint: 4 Weeks. Method of measurement: questionnarie.;Abdominal pain. Timepoint: 4 weeks. Method of measurement: questionnarie.;Painful defecation. Timepoint: 4 weeks. Method of measurement: Questionnarie. | — |
Secondary
| Measure | Time frame |
|---|---|
| Success treatment. Timepoint: 4 weeks. Method of measurement: Success treatment defined as = 3 Bowel Movements per week,= 2 incontinence per month and no abdominal pain.;Adverse effects. Timepoint: 4 weeks. Method of measurement: Questionnarie. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Manijh Khalili
Tehran University of Medical Sciences
Outcome results
None listed