Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||N/A - 14 Years|
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Milan|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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).
- - Lugano Switzerland.
- - 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.
- - 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.
Active Comparator: Probiotic
Placebo Comparator: Placebo
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.