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

NCT04160767 | Unknown Phase 4

• 1 other identifier: 2015/ST/135-3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Celiac Disease

Keywords

Celiac disease; Gut microbiota

Outcome Measures

Primary Outcomes (9)

• 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

Secondary Outcomes (21)

• 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

• 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

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Drug: Probiotic Vivomixx; Behavioral: Gluten free diet

Placebo

PLACEBO COMPARATOR

Behavioral: Gluten free diet; Other: Placebo

Interventions

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.

Probiotic

Gluten free diet BEHAVIORAL

Gluten free diet will be encouraged in both arms

Placebo; Probiotic

Placebo OTHER

Placebo with same taste than VIVOMIXX, containing maltose and silicon dioxide once a day for 4 months.

Placebo

Eligibility Criteria

• Age: Up to 14 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Ospedale San Paolo

Milan, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Paediatrician, University of Milan Researcher

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 13, 2019
• Study Start: January 30, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)