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

Constipation - Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05191810
• Other study ID #: ZAPWUM11/2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2022
• Source: Medical University of Warsaw
• Contact: Piotr Dziechciarz, MD PhD
• Phone: +48223179539
• Email: piotr.dziechciarz[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

References & Publications (7)

Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15. pii: S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. [Epub ahead of print] — View 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. Review. — View Citation

Hyams JS, Di Lorenzo C, Saps M, Shulman RJ, Staiano A, van Tilburg M. Functional Disorders: Children and Adolescents. Gastroenterology. 2016 Feb 15. pii: S0016-5085(16)00181-5. doi: 10.1053/j.gastro.2016.02.015. [Epub ahead of print] — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	8 weeks
Secondary	Frequency (number per week) of bowel movements during the fourth and last weeks of intervention	One of the Rome IV constipation criteria	8 weeks
Secondary	Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention	One of the Rome IV constipation criteria	8 weeks
Secondary	Painful bowel movements (number per week) during the fourth and last weeks of intervention	One of the Rome IV constipation criteria	8 weeks
Secondary	Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention	Symptoms related to constipation	8 weeks
Secondary	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).	8 weeks
Secondary	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.	8 weeks
Secondary	Time (days) from the start of intervention needed to achieve treatment success.	Time needed to no longer fulfill the Rome IV constipation criteria	8 weeks
Secondary	Adverse events during intervention (number and type of reported adverse events)	Any adverse events reported by the patient or caregiver	8 weeks