Comparison between the laxa plus barij and Polyethylene glycol in the pediatric constipation

Comparative evaluation between the laxa plus barij and Polyethylene glycol (4000) in the pediatric functional constipation in chidren 2 to 15 years old

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190410043224N3

Enrollment

Registered

2020-06-21

Start date

2020-06-21

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

Functional constipation. Other constipation

Interventions

Intervention 1: 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

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Constipation improvement. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Clinical Examination; Questionnaire of Constipation Evaluation.	—

Secondary

Measure	Time frame
Treatment side effects. Timepoint: During the study and 8 weeks after the intervention. Method of measurement: Clinical Examination; Questionnaire of Constipation Evaluation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShima Saeidi

Esfahan University of Medical Sciences

shimasaeidi369@gmail.com+98 31 3386 6266

Outcome results

None listed

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