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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 14 Years
Gender Male
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04160767
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Milan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

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.
At each time point clinic evaluation, nutritional assessment and blood testing will be made. Data collection will include:
  • - Systemic arterial blood pressure; - Anthropometric measures (height, weight, body mass index, waist circumference, triceps skinfold) - Clinical evaluation including presence/absence of oral aphtous stomatitis - Measure of chinolinic acid, serotonin, ghrelin (analysis will be made at Istituto Malattie Infettive, Università La Sapienza, Roma).
  • - Dosing of inflammatory markers (analysis will be made at Health Sciences Department, San Paolo Hospital).
  • - Metabolomics on stool samples (analysis will be made at Bologna University, Dipartimento di Scienze e Tecnologie Agro-Alimentari, Cesena, with a financial fund by MENDES S.
A.
  • - Lugano Switzerland).
  • - Routine blood testing including complete blood cell count, vitamin B6, acid folic, vitamin B12, vitamin D 25'OH, fasting glucose, fasting insulin, total cholesterol, LDL and HDL cholesterol, Apolipoprotein A1 and Apolipoprotein B, triglycerides, homocistein, auto-antibody anti endomisium and anti-transglutaminase, - Genetic testing for MTHFR gene - ESR, highly sensitive CRP, IL6, TNFalfa, fibrinogen - Fecal calprotectin.

Arms & Interventions

Arms

Active Comparator: Probiotic

Placebo Comparator: Placebo

Interventions

Drug: - Probiotic Vivomixx

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.

Behavioral: - Gluten free diet

Gluten free diet will be encouraged in both arms

Other: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ospedale San Paolo, Milan, Italy

Status

Recruiting

Address

Ospedale San Paolo

Milan, , 20142

Site Contact

Elvira Verduci, MD PhD Assistant Professor

elvira.verduci@unimi.it

+39 0281844508

The content provided by the Celiac Disease Foundation on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to: Privacy Policy and Terms of Use.