Treatment of functional constipation

The effect of adding probiotic to poly ethylene glycol in shortening the duration of treatment and prevention of early recurrency in pediatric functional constipation.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015072723363N1

Enrollment

Registered

2015-12-13

Start date

2015-08-23

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. Other functional intestinal disordes

Interventions

Intervention 1: Intervention Group: Received Polyethylene Glycol with generic Name Pidrolax manufactored by Sepidaj and in 70 gr package that soluted in 100 cc water, 0.6 gr/kg/day with mix of probiot

Treatment - Drugs

Intervention Group: Received Polyethylene Glycol with generic Name Pidrolax manufactored by Sepidaj and in 70 gr package that soluted in 100 cc water, 0.6 gr/kg/day with mix of probiotics with generic

Control group: Received Polyethylene Glycol with generic Name Pidrolax manufactored by Sepidaj and in 70 gr package that soluted in 100 cc water, 0.6 gr/kg/day for 8 weeks.Then fallow up for 8 weeks.

Eligibility

Sex/Gender

All

Age

2 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 2 to 10 years old children who refer to Amirkola children's Hospital with functional constipation based on ROME III criteria. Exclusion criteria: children beyond 2 years and over 10 years; organic constipation; use other drug induced constipation or diarrhea; or history of use pidrolax and probiotic in 1 years later.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The evaluation response to treatment within 8 weeks according ROME III by evaluation of frequency of defecation in week. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Defecation without pain 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Defecation incontinency 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Drug admission in two group 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Adverse effect of drugs in two group 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.	—

Measure

Time frame

The evaluation response to treatment within 8 weeks according ROME III by evaluation of frequency of defecation in week. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Defecation without pain 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Defecation incontinency 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Drug admission in two group 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Adverse effect of drugs in two group 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.

—

Secondary

Measure	Time frame
Early relapse of constipation according ROME III criteria after off of drug or need to beginning Pidrolax over 4 weeks up to end of drug. Timepoint: 4 weeks after end of treatment. Method of measurement: Questionnaire that filling with parents.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohadese Mahdavi

Amirkola Children's Hospital

Mahdavi.m.dr@gmail.com+98 11 3235 4951

Outcome results

None listed

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