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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control Group | No Intervention | Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational information | Behavioral | Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Frequency (number per week) of bowel movements during the fourth and last weeks of intervention |
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Inclusion Criteria:
Children with functional constipation diagnosed based on Rome IV criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Dziechciarz, MD PhD | Contact | +48223179539 | piotr.dziechciarz@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Piotr Dziechciarz, MD PhD | Department of Pediatrics of the Medical University of Warsaw | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29656863 | Background | 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. | |
| 27144631 | Background |
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Plan to share data on request via e-mail
1.01.2022-31.12.2024
we plan to share all individual patients data on every outcome measure on request from any other researcher after completion of the study
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One of the Rome IV constipation criteria |
| 8 weeks |
| Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention | One of the Rome IV constipation criteria | 8 weeks |
| Painful bowel movements (number per week) during the fourth and last weeks of intervention | 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 | Symptoms related to constipation | 8 weeks |
| 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 |
| 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 |
| 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 |
| Adverse events during intervention (number and type of reported adverse events) | Any adverse events reported by the patient or caregiver | 8 weeks |
| 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. |
| 27144632 | 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. |
| 24345831 | 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. |
| 28450053 | 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. |
| 33737146 | 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. |
| 29380480 | 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. |