Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
90 patients with celiac disease who follow gluten free diet will be enrolled. INCLUSION CRITERIA
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.
At each time point clinic evaluation, nutritional assessment and blood testing will be made. Data collection will include:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Vivomixx | Drug | VIVOMIXX 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vitamin B6, folic acid, vitamin B12 and 25'OH vitamin D levels in blood | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in homocysteine levels in blood | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in ghrelin, chinolinic acid and serotonin levels | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in fecal metabolomics (including production of short chain fatty acids verified by gas-chromatography) | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in highly sensitive C reactive protein levels | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in erythrocite sedimentation rate | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in fibrinogen blood levels | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in IL-6 blood levels | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in Tumor Necrosis Factor alfa blood levels | Time point 0: day 0 Time point 1: after 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body mass index | Time point 0: day 0 Time point 1: after 4 months | |
| Changes in systemic arterial systolic and diastolic blood pressure | Time point 0: day 0 Time point 1: after 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Paolo | Recruiting | Milan | 20142 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Gluten free diet | Behavioral | Gluten free diet will be encouraged in both arms |
|
| Placebo | Other | Placebo with same taste than VIVOMIXX, containing maltose and silicon dioxide once a day for 4 months. |
|
| Changes in height | Time point 0: day 0 Time point 1: after 4 months |
| Changes in weight | Time point 0: day 0 Time point 1: after 4 months |
| Changes in waist circumference | Time point 0: day 0 Time point 1: after 4 months |
| Entity of reduction of triceps skinfold thickness | Time point 0: day 0 Time point 1: after 4 months |
| Changes in prevalence of aphtous stomatitis | Time point 0: day 0 Time point 1: after 4 months |
| Changes in chinolinic acid, serotonin, ghrelin levels in blood | Time point 0: day 0 Time point 1: after 4 months |
| Changes in complete cell blood count | Time point 0: day 0 Time point 1: after 4 months |
| Changes in total cholesterol levels | Time point 0: day 0 Time point 1: after 4 months |
| Changes in HDL cholesterol levels | Time point 0: day 0 Time point 1: after 4 months |
| Changes in LDL cholesterol levels | Time point 0: day 0 Time point 1: after 4 months |
| Changes in triglycerides levels | Time point 0: day 0 Time point 1: after 4 months |
| Changes in Apolipoprotein A1 levels | Time point 0: day 0 Time point 1: after 4 months |
| Changes in Apolipoprotein B levels | Time point 0: day 0 Time point 1: after 4 months |
| Changes in fasting glucose levels | T0 T1 (+4 months) |
| Changes in fasting insulin levels | Time point 0: day 0 Time point 1: after 4 months |
| Changes in auto-antibody anti endomisium titer | Time point 0: day 0 Time point 1: after 4 months |
| Changes in auto-antibody anti-transglutaminase titer | Time point 0: day 0 Time point 1: after 4 months |
| Changes in fecal calprotectin levels | Time point 0: day 0 Time point 1: after 4 months |
| Prevalence of wildtype allele of MTHFR gene by gene sequencing | Time point 0: day 0 (at the enrollement) |
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055050 | Diet, Gluten-Free |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided