NCT06207721

Brief Summary

Children diagnosed with functional constipation are subjected to physical therapy combined with conventional treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

January 5, 2024

Last Update Submit

March 28, 2024

Conditions

Physical Therapy in Pediatric Functional Constipation

Outcome Measures

Primary Outcomes (1)

  • Rome-III criteria

    assessment for functional constipation symptoms

    after 6 months of interventions

Secondary Outcomes (1)

  • short form 36 questionnaire

    after 6 months of interventions

Study Arms (2)

Control group (A)

EXPERIMENTAL

conventional treatment by diet regimen and laxatives

Drug: Polyethylene Glycols

study Group (B)

EXPERIMENTAL

physical therapy program in addition to conventional treatment by diet regimen and laxatives

Drug: Polyethylene GlycolsOther: Physical therapy program

Interventions

Polyethylene GlycolsDRUG

Polyethylene Glycols syrup (0.7 g/kg daily)

Control group (A)study Group (B)
Physical therapy programOTHER

The physical therapy program includes exercises and massage

study Group (B)

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children diagnosed as functional constipation.
  • aged from 4 to 18 years old
  • from both sex

You may not qualify if:

  • children diagnosed as constipation caused by medicine Bowel surgery, Endocrine and metabolic disorders , Neurological and psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

Related Publications (1)

  • Soliman A, AboAli SEM, Abdel Karim AE, Elsamahy SA, Hasan J, Hassan BA, Mohammed AH. Effect of adding telerehabilitation home program to pharmaceutical treatment on the symptoms and the quality of life in children with functional constipation: a randomized controlled trial. Eur J Pediatr. 2024 Sep;183(9):3943-3958. doi: 10.1007/s00431-024-05639-8. Epub 2024 Jun 26.

    PMID: 38922435DERIVED

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor at faculty of physical therapy

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

October 1, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations

EG(1)