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| Name | Class |
|---|---|
| Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna | OTHER |
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The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation
Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation.
Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools.
It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-only | Experimental | Polyethylene glycol 4000 only (PEG-only). |
|
| PEG-EL | Active Comparator | Polyethylene glycol 3350 with electrolytes (PEG-EL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol with electrolytes | Drug | Constipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks. Faecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card | 4 weeks of observation |
| Efficacy | Feacal impaction resolution | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical tolerability | Recording of all Adverse Events (AEs) occurred during the study | 4 weeks of observation |
| Acceptability | Palatability and easy of taking the solution evaluated by a 5-points scale |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23152962 | Derived | Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D005244 | Fecal Impaction |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007415 | Intestinal Obstruction |
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| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D004573 | Electrolytes |
| ID | Term |
|---|---|
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
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| Polyethylene glycol | Device | Constipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children > 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks. Faecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days. |
|
|
| 4 weeks of observation |
| Compliance | Percentage of patients who took more than 80% of the prescribed dose | 4 weeks |
| Efficacy | Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card | 4 weeks |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011108 |
| Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D007287 | Inorganic Chemicals |