Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children

March 2, 2022 updated by: Piotr Dziechciarz, MD, Medical University of Warsaw
The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Constipation is a common condition in children which affects around 10% of the paediatric population. In 95 % cases it is a functional disorder of the digestive tract, without any organic cause. Recommendations of lifestyle modifications accompanying pharmacological treatment of constipation are very popular among healthcare providers, although there is limited data concerning non-pharmacological treatment methods of this condition. Adequate for age fluid intake is now recommended for patients with constipation. Further research is needed to form stronger recommendations in the future. The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in children.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Children with functional constipation diagnosed based on Rome IV criteria

Exclusion Criteria:

  1. Children with organic causes of constipation; eg, anorectal malformations, or Hirschsprung's disease
  2. Children who fulfil the criteria of Irritable Bowel Syndrome
  3. Significant, unstabilised chronic health conditions requiring major drug adjustment during the last 3 months.
  4. Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months
  5. Recurrent or unexplained fevers
  6. History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy, or hernia repairs
  7. Concomitant use of drugs that are known to affect gastrointestinal motility
  8. Established diagnoses of autism spectrum disorders
  9. Mental retardation
  10. Children who are exclusively breastfed
  11. Non-retentive faecal incontinence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study Group
Macrogol (PEG 3350, PEG 4000), standard dosage Educational intervention: Recommendation of adequate for age fluid intake plus standard information about non-pharmacological supporting treatment
Behavioral: Educational information
Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake
NO_INTERVENTION: Control Group
Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who no longer fulfill the Rome IV constipation criteria
Time Frame: last week of intervention
Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention.
last week of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention
Time Frame: 8 weeks
Assessed by a 2-day food and fluid intake diary made by patient and/or caregiver at the beginning of the intervention and during the last week of intervention
8 weeks
Frequency (number per week) of bowel movements during the fourth and last weeks of intervention
Time Frame: 8 weeks
One of the Rome IV constipation criteria
8 weeks
Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention
Time Frame: 8 weeks
One of the Rome IV constipation criteria
8 weeks
Painful bowel movements (number per week) during the fourth and last weeks of intervention
Time Frame: 8 weeks
One of the Rome IV constipation criteria
8 weeks
Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention
Time Frame: 8 weeks
Symptoms related to constipation
8 weeks
Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention
Time Frame: 8 weeks
Macrogol dose needed to achieve treatment success (no longer fulfilling the Rome IV constipation criteria).
8 weeks
Need for rescue laxative treatment during the intervention (number of cases)
Time Frame: 8 weeks
In case of lack of bowel movements for three consecutive days, the macrogol dose will be augmented to 1-1.5g/kg/day until a bowel movement occurs.
8 weeks
Time (days) from the start of intervention needed to achieve treatment success.
Time Frame: 8 weeks
Time needed to no longer fulfill the Rome IV constipation criteria
8 weeks
Adverse events during intervention (number and type of reported adverse events)
Time Frame: 8 weeks
Any adverse events reported by the patient or caregiver
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Piotr Dziechciarz, MD PhD, Department of Pediatrics of the Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 7, 2022

Primary Completion (ANTICIPATED)

December 30, 2024

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (ACTUAL)

January 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZAPWUM11/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share data on request via e-mail

IPD Sharing Time Frame

1.01.2022-31.12.2024

IPD Sharing Access Criteria

we plan to share all individual patients data on every outcome measure on request from any other researcher after completion of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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