drugset / Trial / NCT04160767

Celiac Disease and Vitamin Status: Evaluation of the Effect of Supplementation With a Probiotic (VIVOMIXX®) in a Cohoort of Celiac Patients

NCT04160767

Phase 4 Unknown 90 enrolled University of Milan
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2019-01-30
Primary completion
2021-07
Completion
2021-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vivomixx Other / unclassified 4.5e+11 cells

Indications