Comparison of effect of probiotic with polyethylene glycol,with polyethylene glycol alone in the treatment of functional constipation in children

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138812222434N3

Enrollment

Registered

2015-05-10

Start date

2013-09-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

constipation. Retention,retained-fecal

Interventions

Intervention 1: PEG solution 40% : 0.5gr/kg/dose TID Cap probiotic: 1.5*109 CFU TID. Intervention 2: PEG solution 40% : 0.5gr/kg/dose TID for 6 week.

Treatment - Drugs

PEG solution 40% : 0.5gr/kg/dose TID Cap probiotic: 1.5*109 CFU TID

PEG solution 40% : 0.5gr/kg/dose TID for 6 week

Eligibility

Sex/Gender

All

Age

1 Months to 18 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Stool frequency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Stool incontinence. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Stool consistency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Abdominal pain. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Pain on defecation. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.	—

Measure

Time frame

Stool frequency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Stool incontinence. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Stool consistency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Abdominal pain. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.;Pain on defecation. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires.

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Secondary

Measure	Time frame
Drug adverse effects and clinical response. Timepoint: 6th week and 12th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on stool frequency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on Fecal incontinence. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on stool Consistency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of clinical response of pain during defecation. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on abdominal pain. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.	—

Measure

Time frame

Drug adverse effects and clinical response. Timepoint: 6th week and 12th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on stool frequency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on Fecal incontinence. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on stool Consistency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of clinical response of pain during defecation. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.;Evaluation of Clinical response on abdominal pain. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Keshtkari

Shiraz University of Medical Sciences

keshtkari@sums.ac.ir00

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026