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Effects of Psyllium seed husk powder vs. Polyethylene glycol on constipation in children

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013021112437N1
Enrollment
160
Registered
2017-08-25
Start date
2017-08-23
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 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. Interventi
Treatment - Drugs
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.
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.
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.
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.

Sponsors

Vice chancellor for research of Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Defecation frequency. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Defecation without pain. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Drug admission. Timepoint: 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Defecation incontinency. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.;Adverse effects of drugs. Timepoint: 8 weeks after intervention. Method of measurement: Recorded through questionnaires filled by parents.

Secondary

MeasureTime frame
Early constipation relapse discontinue medication. Timepoint: 4 weeks after end of treatment. Method of measurement: Questionnaire that filling with parents.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Sharif

Kashan University of Medical Sciences

mrsharifmd@yahoo.com+98 31 5554 0026

Outcome results

None listed

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