The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Local PEG4000, Commercial PEG4000.
- Кому может быть актуально
- Состояния в реестре: Functional Constipation. Базовые параметры: 6 мес. — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Таиланд
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Faculty of Medicine, Chulalongkorn University
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Local PEG4000
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. - Препарат Commercial PEG4000
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.
Первичные конечные точки
- The frequency of stool [Срок оценки: At 7 days, 14 days, 28 days and 56 days]
- Stool consistency assessed by Bristol stool chart [Срок оценки: At 7 days, 14 days, 28 days and 56 days]
Вторичные конечные точки (6)
- Fecal incontinence [Срок оценки: At 7 days, 14 days, 28 days and 56 days]
- Rectal diameter measured by transabdominal ultrasonography [Срок оценки: At 7 days, 14 days, 28 days, 56 days and 2 years]
- Anterior wall thickness measured by transabdominal ultrasonography [Срок оценки: At 7 days, 14 days, 28 days, 56 days and 2 years]
- Adverse events [Срок оценки: At 7 days, 14 days, 28 days and 56 days]
- Palatability of medication assessed by facial Hedonic scale [Срок оценки: At 7 days, 14 days, 28 days and 56 days]
- Change of gut microbiota before and after treatment [Срок оценки: At baseline and 56 days]
Критерии участия
Критерии включения
Children will be enrolled in this study when they meet 2 criteria:
- Age from 6 months to 18 years old
- Children are diagnosed with FC according to ROME IV criteria
Критерии исключения
Children will be excluded from the study if they meet any of the following criteria:
- Having an organic cause of constipation such as anorectal malformations, Hirschsprung disease, myelomeningocele, hypothyroidism, etc.
- Suspected GI obstruction
- Receiving medication affecting bowel movement
- Having a history of allergy to PEG and stevia.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Таиланд · 1 центр
- Faculty of Medicine, Chulalongkorn University — Bangkok
Идентификаторы
NCT: NCT06357897 · 0093/67