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This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.
Total 52 children age 6 months to 18 years old diagnosed with functional constipation will be enrolled in this study. They will be randomised in Group A or Group B.
Children in group A will receive PEG-Chula at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
Children in group B will receive the standard PEG formula (Forlax) at a dose of 0.5 - 1 g/kg/day for a duration of 56 days.
PEG-Chula and standard PEG will be prepared in sachets with similar packaging and appearance labelled A, B, C, D.
Children in both groups will also receive counseling on toilet training, water intake, and fiber intake in the same manner.
Parents will be advised to record symptoms, dietary intake, and dose of medication in a logbook.
Children will visit the researchers on days 7, 14, 28, and 56 to collect data on symptoms, stool diameter, bowel size measured by ultrasound, side effects, and medication compliance. Children with poor compliance will be excluded from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-Chula | Experimental | PEG-Chula is developed from local PEG 4000 used at King Chulalongkorn Memorial Hospital (KCMH) with the addition of sweetener and flavours and prepared into sachets labelled A, B, C and D. |
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| Standard PEG | Other | Standard PEG (Forlax) is prepared into the sachets labelled A, B, C and D with similar packaging and appearance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local PEG4000 | Drug | PEG-Chula is developed from PEG 4000 used at King Chulalongkorn Memorial Hospital with added sweetener and flavours. Children will be given PEG-Chula at a dose of 0.5 - 1 g/kg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of stool | The frequency of stool per day | At 7 days, 14 days, 28 days and 56 days |
| Stool consistency assessed by Bristol stool chart | The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool | At 7 days, 14 days, 28 days and 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal incontinence | Number of fecal incontinence occurs per day | At 7 days, 14 days, 28 days and 56 days |
| Rectal diameter measured by transabdominal ultrasonography | Rectal diameter in centimeters is measured by transabdominal ultrasonography. |
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Inclusion Criteria:
Children will be enrolled in this study when they meet 2 criteria:
Exclusion Criteria:
Children will be excluded from the study if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duc Long Tran, M.D. | Contact | +66916668748 | tdlong@ctump.edu.vn |
| Name | Affiliation | Role |
|---|---|---|
| Palittiya Sintusek, Ph.D. | Chulalongkorn University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
The data were collected anonymous.
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Intervention group received PEG-Chula Control group received Forlax
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The intervention and control were prepared in the similar sachet and was blinded to investigatiors, participants and guardians
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| Commercial PEG4000 | Drug | For commercial PEG, We use Forlax as the control group. Children will be given Forlax at a dose of 0.5 - 1 g/kg/day. |
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| At 7 days, 14 days, 28 days, 56 days and 2 years |
| Anterior wall thickness measured by transabdominal ultrasonography | Anterior wall thickness in centimeters is measured by transabdominal ultrasonography. | At 7 days, 14 days, 28 days, 56 days and 2 years |
| Adverse events | Adverse events (i.e diarrhea, abdominal pain, bloating, nausea or vomiting) | At 7 days, 14 days, 28 days and 56 days |
| Palatability of medication assessed by facial Hedonic scale | The facial Hedonic scale contains 5 pictures of facial expression and number 1 mean dislike very much while number 5 means like very much | At 7 days, 14 days, 28 days and 56 days |
| Change of gut microbiota before and after treatment | Stools is collected before treatment at baseline and at the end of treatment. Gut microbiota was analyzed by Nanopore technique. | At baseline and 56 days |