LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema)
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: Lactobacillus Paracasei LPB27, Maltodextrin.
- Кому может быть актуально
- Состояния в реестре: Eczema, Allergy. Базовые параметры: 3 мес. — 3 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
- Австралия
- 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
Lactobacillus Paracasei LPB27 On Early Childhood Eczema
Обзор
The LaCE study is a double-blind, randomised, placebo-controlled trial examining the effectiveness of the probiotic Lactobacillus paracasei LPB27 in treating eczema in young children.
Подробное описание
Childhood eczema is a common and chronic, relapsing disease of the skin which affects up to 20% of the paediatric population. Eczema has significant impact on the quality of life of those affected. Its main symptoms are dry skin and intense itching.
There is currently no cure for eczema but there are treatments that try to relieve symptoms. These commonly include topical moisturisers and topical corticosteroids.
Although topical corticosteroids are effective in minimising symptoms, there is a prevailing and universal fear of using topical corticosteroids which is one of the main reasons for poor treatment compliance.
There have been emerging interests in prevention and treatment of eczema through modulation of the gut microbiome. The gut microbiome is a key regulator for the immune system and there is evidence that the composition of gut microbiome may reduce allergies by driving maturation of the immune system. It was shown that people with eczema have different bacteria in their gut compared to people without eczema. Therefore, this study's hypothesis is that administration of oral probiotics will benefit young children with eczema by improving their gut microbiome and quality of life.
Вмешательства
- Пищевая добавка Lactobacillus Paracasei LPB27
Probiotic - Другое Maltodextrin
Placebo
Первичные конечные точки
- Proportion of patients achieving treatment success [Срок оценки: Between baseline and 12 weeks]
Вторичные конечные точки (11)
- Mean change in SCORAD index [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- First use of rescue medication [Срок оценки: From baseline to time of starting rescue medication (up to 12 weeks)]
- Mean change in RECAP [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in IDQOL [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in EASI [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in IGA [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in POEM [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Use of topical corticosteroids [Срок оценки: From baseline to 12 weeks]
- Mean change in TOPICOP score [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in gut microbiota [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
- Mean change in skin microbiota [Срок оценки: From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier)]
Критерии участия
Критерии включения
- Age: 3 months to 3 years old
- Diagnosis: Eczema (atopic dermatitis) diagnosed clinically by a paediatric dermatologist or immunologist.
- Severity: Investigator Global Assessment for Atopic Dermatitis (IGA) severity of 1-3 (almost clear, mild, moderate) and a SCORAD score greater than 8.7.
- Willingness and ability of the subject to comply with the protocol requirements.
Критерии исключения
- Patients on systemic immunosuppression and/or biologic agents (participants who start systemic immunosuppression and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).
- Mothers who are breastfeeding and on probiotics but not willing to stop probiotics.
- Child already on probiotics and parents not willing to stop during the entire study period (washout period of 4 weeks; including formulas that contains probiotics).
- Eczema complicated by active skin infection e.g. impetigo/cellulitis/ eczema herpeticum (can be considered once active infection resolved).
- Child currently on oral or IV antibiotics (washout period of 4 weeks allowable once antibiotics completed). Participants who require antibiotics after being enrolled in the study may continue on the study as usual.
- Immunodeficient disorders.
- Chronic disorder involving the gastrointestinal tract (e.g., inflammatory bowel disease, short gut syndrome, cystic fibrosis).
- Known hypersensitivity to components contained in study product.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Австралия · 1 центр
- Sydney Children's Hospital — Randwick
Идентификаторы
NCT: NCT06584552 · 2024001_LaCE