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

Primary Purpose

Constipation - Functional

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational information
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional focused on measuring fluid intake, functional constipation, children, PEG, macrogol, educational intervention

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study Group

    Control Group

    Arm Description

    Macrogol (PEG 3350, PEG 4000), standard dosage Educational intervention: Recommendation of adequate for age fluid intake plus standard information about non-pharmacological supporting treatment

    Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment

    Outcomes

    Primary Outcome Measures

    Number of Participants who no longer fulfill the Rome IV constipation criteria
    Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention.

    Secondary Outcome Measures

    Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention
    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
    Frequency (number per week) of bowel movements during the fourth and last weeks of intervention
    One of the Rome IV constipation criteria
    Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention
    One of the Rome IV constipation criteria
    Painful bowel movements (number per week) during the fourth and last weeks of intervention
    One of the Rome IV constipation criteria
    Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention
    Symptoms related to constipation
    Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention
    Macrogol dose needed to achieve treatment success (no longer fulfilling the Rome IV constipation criteria).
    Need for rescue laxative treatment during the intervention (number of cases)
    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.
    Time (days) from the start of intervention needed to achieve treatment success.
    Time needed to no longer fulfill the Rome IV constipation criteria
    Adverse events during intervention (number and type of reported adverse events)
    Any adverse events reported by the patient or caregiver

    Full Information

    First Posted
    December 29, 2021
    Last Updated
    March 2, 2022
    Sponsor
    Medical University of Warsaw
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05191810
    Brief Title
    Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children
    Official Title
    Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 7, 2022 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Warsaw

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation - Functional
    Keywords
    fluid intake, functional constipation, children, PEG, macrogol, educational intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study Group
    Arm Type
    Experimental
    Arm Description
    Macrogol (PEG 3350, PEG 4000), standard dosage Educational intervention: Recommendation of adequate for age fluid intake plus standard information about non-pharmacological supporting treatment
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational information
    Intervention Description
    Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake
    Primary Outcome Measure Information:
    Title
    Number of Participants who no longer fulfill the Rome IV constipation criteria
    Description
    Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention.
    Time Frame
    last week of intervention
    Secondary Outcome Measure Information:
    Title
    Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention
    Description
    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
    Time Frame
    8 weeks
    Title
    Frequency (number per week) of bowel movements during the fourth and last weeks of intervention
    Description
    One of the Rome IV constipation criteria
    Time Frame
    8 weeks
    Title
    Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention
    Description
    One of the Rome IV constipation criteria
    Time Frame
    8 weeks
    Title
    Painful bowel movements (number per week) during the fourth and last weeks of intervention
    Description
    One of the Rome IV constipation criteria
    Time Frame
    8 weeks
    Title
    Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention
    Description
    Symptoms related to constipation
    Time Frame
    8 weeks
    Title
    Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention
    Description
    Macrogol dose needed to achieve treatment success (no longer fulfilling the Rome IV constipation criteria).
    Time Frame
    8 weeks
    Title
    Need for rescue laxative treatment during the intervention (number of cases)
    Description
    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.
    Time Frame
    8 weeks
    Title
    Time (days) from the start of intervention needed to achieve treatment success.
    Description
    Time needed to no longer fulfill the Rome IV constipation criteria
    Time Frame
    8 weeks
    Title
    Adverse events during intervention (number and type of reported adverse events)
    Description
    Any adverse events reported by the patient or caregiver
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children with functional constipation diagnosed based on Rome IV criteria Exclusion Criteria: Children with organic causes of constipation; eg, anorectal malformations, or Hirschsprung's disease Children who fulfil the criteria of Irritable Bowel Syndrome Significant, unstabilised chronic health conditions requiring major drug adjustment during the last 3 months. Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months Recurrent or unexplained fevers History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy, or hernia repairs Concomitant use of drugs that are known to affect gastrointestinal motility Established diagnoses of autism spectrum disorders Mental retardation Children who are exclusively breastfed Non-retentive faecal incontinence
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Piotr Dziechciarz, MD PhD
    Phone
    +48223179539
    Email
    piotr.dziechciarz@wum.edu.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Piotr Dziechciarz, MD PhD
    Organizational Affiliation
    Department of Pediatrics of the Medical University of Warsaw
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    29656863
    Citation
    Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, Di Lorenzo C, Benninga MA, Tabbers MM. Prevalence of Functional Defecation Disorders in Children: A Systematic Review and Meta-Analysis. J Pediatr. 2018 Jul;198:121-130.e6. doi: 10.1016/j.jpeds.2018.02.029. Epub 2018 Apr 12.
    Results Reference
    background
    PubMed Identifier
    27144631
    Citation
    Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.
    Results Reference
    background
    PubMed Identifier
    27144632
    Citation
    Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15:S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. Online ahead of print.
    Results Reference
    background
    PubMed Identifier
    24345831
    Citation
    Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.
    Results Reference
    background
    PubMed Identifier
    28450053
    Citation
    Boilesen SN, Tahan S, Dias FC, Melli LCFL, de Morais MB. Water and fluid intake in the prevention and treatment of functional constipation in children and adolescents: is there evidence? J Pediatr (Rio J). 2017 Jul-Aug;93(4):320-327. doi: 10.1016/j.jped.2017.01.005. Epub 2017 Apr 25.
    Results Reference
    background
    PubMed Identifier
    33737146
    Citation
    Santucci NR, Chogle A, Leiby A, Mascarenhas M, Borlack RE, Lee A, Perez M, Russell A, Yeh AM. Non-pharmacologic approach to pediatric constipation. Complement Ther Med. 2021 Jun;59:102711. doi: 10.1016/j.ctim.2021.102711. Epub 2021 Mar 15.
    Results Reference
    background
    PubMed Identifier
    29380480
    Citation
    Koppen IJN, Saps M, Lavigne JV, Nurko S, Taminiau JAJM, Di Lorenzo C, Benninga MA. Recommendations for pharmacological clinical trials in children with functional constipation: The Rome foundation pediatric subcommittee on clinical trials. Neurogastroenterol Motil. 2018 Apr;30(4):e13294. doi: 10.1111/nmo.13294. Epub 2018 Jan 30.
    Results Reference
    background

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