Clinical trial NCT05191810: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation - Functional
Keywords: fluid intake
functional constipation
children
PEG
macrogol
educational intervention
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants who no longer fulfill the Rome IV constipation criteria
timeFrame: last week of intervention
Secondary outcomes:
measure: Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention
timeFrame: 8 weeks
measure: Frequency (number per week) of bowel movements during the fourth and last weeks of intervention
timeFrame: 8 weeks
measure: Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention
timeFrame: 8 weeks
measure: Painful bowel movements (number per week) during the fourth and last weeks of intervention
timeFrame: 8 weeks
measure: Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention
timeFrame: 8 weeks
measure: Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention
timeFrame: 8 weeks
measure: Need for rescue laxative treatment during the intervention (number of cases)
timeFrame: 8 weeks
measure: Time (days) from the start of intervention needed to achieve treatment success.
timeFrame: 8 weeks
measure: Adverse events during intervention (number and type of reported adverse events)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Pediatrics of the Medical University of Warsaw
name: Piotr Dziechciarz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.