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

NCT05191810 | Unknown

• 1 other identifier: ZAPWUM11/2021
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation - Functional

Keywords

fluid intake; functional constipation; children; PEG; macrogol; educational intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  last week of intervention

Secondary Outcomes (9)

• Average daily fluid intake (ml) before 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

  8 weeks

• Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention

  8 weeks

• Painful bowel movements (number per week) during the fourth and last weeks of intervention

  8 weeks

• Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention

  8 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Educational information BEHAVIORAL

Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake

Study Group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with functional constipation diagnosed based on Rome IV criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Related Publications (7)

• 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.

  PMID: 29656863 BACKGROUND

• 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.

  PMID: 27144631 BACKGROUND

• 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.

  PMID: 27144632 BACKGROUND

• 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.

  PMID: 24345831 BACKGROUND

• 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.

  PMID: 28450053 BACKGROUND

• 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.

  PMID: 33737146 BACKGROUND

• 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.

  PMID: 29380480 BACKGROUND

Study Officials

• Piotr Dziechciarz, MD PhD

  Department of Pediatrics of the Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Dziechciarz, MD PhD

CONTACT

+48223179539; piotr.dziechciarz@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 14, 2022
• Study Start: March 7, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1.01.2022-31.12.2024
• 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