Celiac Disease and Vitamin Status: Evaluation of the Effect of Supplementation With a Probiotic (VIVOMIXX®) on Vitamin B6, B12, 25'OH D, Folic Acid and Omocystein Levels, Metabolic and Inflammatory Status, and Gut Microbiota Metabolomics in a Cohoort of Celiac Patients

University of Milan1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2019年1月30日最近更新: 2021年2月10日

适应症

干预措施

试验速览

阶段: 4 期
发起方: University of Milan
入组人数: 90
试验地点: 1
主要终点: Changes in homocysteine levels in blood

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Celiac disease is a disorder caused by a disregulation of the immune system which leads to immune response to gluten. Diet therapy is the gold standard of treatment, and the only effective one. Macronutrients and micronutrients deficiency (vitamin D, folic acid, vitamin B12, vitamin B6, iron and zinc), which is in any case far more common in patients who don't follow gluten free diet, can persist in a subset of patients who follow gluten-free diet. Supplementation of vitamins in these patients may have a beneficial role. A recent study in a murine model showed that supplementation with probiotic VIVOMIXX® leads to an increase in expression of vitamin D receptors in proximal and distal colon.

This is an interventional controlled randomized double blind study, which evaluates the effect of VIVOMIXX® on vitamin status.

详细描述

90 patients with celiac disease who follow gluten free diet will be enrolled. INCLUSION CRITERIA

Celiac disease (diagnosis made according to ESPGHAN criteria) EXCLUSION CRITERIA
Supplementation with pre/probiotics in the previous 3 months;
Antibiotic therapy in the previous 3 months;
Comorbidity with other acute (in the previous 3 months) or chronic gastrointestinal disorders
Supplementation with group B vitamins for any reason

Patients enrolled will be referred to Paediatric Gastroenterology Service in San Paolo Hospital at the time of enrollement (T0) and after intervention therapy (T1, + 4 months).

Patients will be randomized in one of the two arms of intervention (VIVOMIXX once a day for 4 months versus placebo once a day for 4 months).

VIVOMIXX® is a probiotic containing 8 differenct strains of bacteria: Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) lactobacilli (L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, L. delbrueckii subsp. bulgaricus DSM 24734). Every sachet contains 450 billions of bacteria, maltose and silicon dioxide. VIVOMIXX® will be freely given by the society MENDES S.A. - Lugano Switzerland.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: — 至 14 Years（Child）
性别: Male
接受健康志愿者: 否

入选标准

•Celiac disease (diagnosis made according to European Society for Paediatric Gastroenterology Hepatology and Nutrition)

排除标准

•Supplementation with pre/probiotics in the previous 3 months;
•Antibiotic therapy in the previous 3 months;
•Comorbidity with other acute (in the previous 3 months) or chronic gastrointestinal disorders
•Supplementation with group B vitamins for any reason

研究组 & 干预措施

Probiotic

Active Comparator

干预措施: Probiotic Vivomixx (Drug)

Probiotic

Active Comparator

干预措施: Gluten free diet (Behavioral)

Placebo

Placebo Comparator

干预措施: Gluten free diet (Behavioral)

Placebo

Placebo Comparator

干预措施: Placebo (Other)