Intervention on New Onset-T1D Children
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: Probiotic Vivomixx®, Placebo.
- Кому может быть актуально
- Состояния в реестре: Type 1 Diabetes. Базовые параметры: 7 лет — 17 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
- Италия
- 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
Assessing the Role of the Gut Microbiome and of the Intestinal Barrier Integrity in the Immune Pathogenesis of Type 1 Diabetes
Обзор
A pilot proof of concept clinical trial will be performed to demonstrate the restoration of gut barrier integrity by administration of beneficial anti-inflammatory gut microbial strains (Lactobacilli-enriched Vivomixx® probiotic) to new onset Type 1 Diabetes Children.
Подробное описание
This is an interventional randomized, 2-arm, single-blind, single-center, placebo-controlled mechanistic clinical trial (1:1).
One sachet of probiotic for children \< 10 years old or two sachets for subjects \> 10 years old dissolved into water or noncarbonated drinks will be administered every day for 90 consecutive days.The primary end point of the study will be the preservation of the residual insulin-producing beta-cell mass measured as the change in C-peptide values at 12 months after the beginning of treatment. Moreover, the investigators will collect blood samples for serological analysis (autoantibodies detection, measurement of biomarkers of gut barrier integrity) and immunological profiling; fecal samples for microbiome and metabolomic analysis. Finally the investigators will assess whether the response to Vivomixx® probiotic remains stable over a long-term period, that is in the absence of active treatment.
Вмешательства
- Пищевая добавка Probiotic Vivomixx®
The correct number of Vivomixx® sachets are given to parents with the indication to administer the dietary supplement as dissolved in drinking water or non-carbonated drinks. - Пищевая добавка Placebo
The correct number of Placebo sachets are given to parents with the indication to administer the dietary supplement as dissolved in drinking water or non-carbonated drinks.
Первичные конечные точки
- Preservation of the residual insulin-producing beta cell mass [Срок оценки: through study completion, an average of 1 year]
- Glycemic control by Time-in-Range (TIR) monitoring [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (5)
- Gut barrier integrity [Срок оценки: through study completion, an average of 1 year]
- Gut microbiome profile [Срок оценки: through study completion, an average of 1 year]
- Measurement by flow cytometry of differences in the percentages of regulatory and inflammatory CD4 T cells [Срок оценки: through study completion, an average of 1 year]
- Measurement by flow cytometry of differences in the percentages of MAIT cells and TCR gamma Delta T cells [Срок оценки: through study completion, an average of 1 year]
- Measurement by flow cytometry of differences in the percentages of innate lymphoid cells [Срок оценки: through study completion, an average of 1 year]
Критерии участия
Критерии включения
- Clinical diagnosis of insulin-dependent type 1 diabetes
- Positive for at least one islet autoantibody (ICA, GADA, IA-2, IAA, ZnT8)
- No more than 3 months from first insulin injection
- ≥ 7 to < 18 year old
Критерии исключения
- Diagnosed with celiac disease, IBD or other intestinal inflammatory pathologies
- Diagnosed with tuberculosis, hepatitis B or C, HIV, or active EBV or CMV infection; significant cardiac disease; conditions associated with immune dysfunction or hematologic dyscrasia (including malignancy, lymphopenia, thrombocytopenia, or anemia); liver or renal dysfunction.
- Ongoing use of systemic medications other than insulin.
- Recent administration of antibiotics (1 months prior to treatment)
- Deemed unlikely or unable to comply with the protocol or have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Autoimmune Pathogenesis Unit — Milan
Публикации
- Dolpady J, Sorini C, Di Pietro C, Cosorich I, Ferrarese R, Saita D, Clementi M, Canducci F, Falcone M. Oral Probiotic VSL#3 Prevents Autoimmune Diabetes by Modulating Microbiota and Promoting Indoleamine 2,3-Dioxygenase-Enriched Tolerogenic Intestinal Environment. J Diabetes Res. 2016;2016:7569431. doi: 10.1155/2016/7569431. Epub 2015 Dec 8. PMID 26779542
- Caballero-Franco C, Keller K, De Simone C, Chadee K. The VSL#3 probiotic formula induces mucin gene expression and secretion in colonic epithelial cells. Am J Physiol Gastrointest Liver Physiol. 2007 Jan;292(1):G315-22. doi: 10.1152/ajpgi.00265.2006. Epub 2006 Sep 14. PMID 16973917
- Korpela R, Niittynen L. Probiotics and irritable bowel syndrome. Microb Ecol Health Dis. 2012 Jun 18;23. doi: 10.3402/mehd.v23i0.18573. eCollection 2012. PMID 23990830
Идентификаторы
NCT: NCT05767450 · RF-2019-123-70721