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| ID | Type | Description | Link |
|---|---|---|---|
| 2/2013 | Other Grant/Funding Number | The Medical University of Warsaw |
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Background:
Aim:
Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children.
Study design:
Randomized, open-label trial.
Randomized, double-blind, placebo controlled trial.
Children will be randomly assigned into 2 groups receiving polyethylene glycol 4000 (Forlax) with an initial dose of either 0.3g/kg, or 0.7 g / kg.
In case of ineffectiveness the dose of medication will be increased every two weeks with 0.2 g/kg. The indication for the increase in dose will be less than 3 bowel movements per week. For children with diarrhea defined as more than 3 loose stools for minimum 2 days or/and severe abdominal pain the macrogol dose of will be reduced every two weeks by 0.2 g/kg. The intervention will last 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyethylene glycol small dose | Experimental | Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks |
|
| Polyethylene glycol high dose | Active Comparator | Polyethylene glycol 4000: 0.7g/kg for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol 4000 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| therapeutic success (passing ≥ 3 stools per week, with no loosening of stool). | the number and consistency of the stool will be recorded at 6th week of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| the number of stools delivered at 6th week of intervention | the number of the stools will be recorded at the 6th week of intervention | |
| the number of incontinence episodes | the number of the incontinence episodes will be recorded at the 6th week of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Horvath, MD | Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt of Pediatrics The Medical University of Warsaw | Warsaw | 01-184 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25162362 | Derived | Dziechciarz P, Horvath A, Szajewska H. Polyethylene glycol 4000 for treatment of functional constipation in children. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):65-8. doi: 10.1097/MPG.0000000000000543. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595214 | polyethylene glycol 4000 |
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| the number of painful defecation | the number of painful defecation will be recorded at the 6th week of intervention |
| the number of episodes of abdominal pain | the number of the episodes of abdominal pain will be recorded at the 6th week of intervention |
| the number of patients needed laxatives during treatment | the number patiens needed laxatives will be recorded for six weeks of intervention |
| side effects | the number and character of the sides effects will be recorded by the patient at the diary during the 6 weeks of the intervention | the number and the character of the side effects will be recorded for six weeks of intervention |