Clinical Research


Large populations of healthy subjects or affected by various conditions facilitate the conduct of several clinical studies. Starting from the evidence obtained in basic science studies an experienced multidisciplinary team composed by pediatricians, immunologists, allergists, dietitians, nutritionists, research nurses, and biostatisticians is involved in numerous studies focused on several topics, including:

  • Nutrition in the first 1000 days
  • Food allergies and Intolerances
  • Obesity and obesity-related conditions
  • Gut microbiome composition and function in physiological conditions and in human diseases
  • Impact of lifestyles, dietary habits, and gut microbiome on immune system and metabolism
  • Effects and mechanisms of action of pre-, pro-, sin- and post-biotics for the prevention and treatment of human diseases


Some ongoing clinical studies:

PREgnancy Mediterranean DIet (PREMEDI) trial
Mediterranean Diet (MD) is a pattern based on eating less red meat, sugar and saturated fat while incorporating more produce, nuts and whole grains in the daily regimen. In adult, adherence to MD has been inversely associated with multifactorial etiology pathologies. We aim to investigate the association between adherence to Mediterranean diet in pregnancy and offspring gene expression involved in the pathogenesis of obesity and allergy in two pregnancy cohorts. Our other objetives are the evaluation of the adherence to MD; the impact of nutritional counseling on eating habits and on adherence to DM; the effects of MD on weight gain and maternal complications (gestational hypertension, infections, gestational diabetes, pre-eclampsia, cesarean section), and on state-weight growth trend, onset of allergies and obesity, use of antibiotics, IQ and fetal complications (natality risk, intrauterine growth retardation, preterm birth, early abortion, shoulder dystocia, fetal macrosomia); the effects of MD on structure (shogun analysis) and function (HPLC, GC / MS, MALDI-TOF) of the intestinal microbiota of mother and child and the dosage of short chain fatty acids in fecal saples of mothers and children; the effects of MD on breastfeeding duration and composition of breast milk (short chain fatty acids, bacterial DNA, adipokines). The PREMEDI is a monocentric, pilot study, controlled-case clinical trial. Pregnant women aged 20-35 years old, in first trimester of pregnancy are assigned through a randomization table to two intervention groups: Group 1: gynecological obstetric follow up + a personalized diet based on MD; Group 2: gynecological obstetric follow up.
https://clinicaltrials.gov/ct2/show/NCT03337802?term=PREMEDI&draw=2&rank=1



 

Gut microbiota as target of intervention against obesity (MATO Study)
The gut microbiota has emerged as an environmental factor that modulates the host's metabolism. Data on gut microbiota composition and function of children affected by obesity and metabolic syndrome are still scantly. We collect fecal samples from pediatric patients (aged 5-18 years) affected by obesity (Group 1), obesity with metabolic syndrome (Group 2) and healthy controls (Group 3) to investigate gut microbiota metagenomic and metabolomic features. The inclusion criteria of subjects involved in MATO study are: Group 1: BMI at or greater than 95th percentile for age and sex; Group 2: BMI at or greater than 95th percentile for age and sex with metabolic syndrome defined by concomitant presence of fasting blood glucose ≥ 100 mg/dl, triglyceride ≥ 150 mg/dl, HDL cholesterol < 40 mg/dl, blood pressure ≥ 130/85 mmHg, abdominal circumference ≥ 90th percentile for age and sex; Group 3: otherwise healthy with BMI < 85th percentile for age and sex. Our hypotesis is that the gut microbiota could be targeted to prevent or treat obesity and metabolic syndrome.



 

The Butyrate Against Obesity (BAO Trial)
The prevalence of overweight and obesity among children is a major problem in public health and it is associated with emergence of comorbidities previously considered to be "adult" diseases including type 2 diabetes mellitus, hypertension, nonalcoholic fatty liver disease, obstructive sleep apnea, and dyslipidemia. The BAO trial is a randomized, double-blinded, placebo-controlled of 6-months trial. Paediatric patients (7-16 years of age) with obesity (BMI at or greater than 95th percentile for age and sex) are randomly assigned in two group: Group 1: hypocaloric diet + butyrate; Group 2: hypocaloric diet + placebo. Fecal samples, fasting blood samples, indirect calorimetry and body composition are taken at baseline and after 6 months. Anthropometry, dietary habits and waist circumference were taken at baseline and every month until the sixth. Preclinical data suggests the role of butyrate, a short chain fatty acid produced by gut fermentation of dietary fiber, in the treatment/prevention of obesity and metabolic diseases. Our central hypothesis is that the butyrate intervention it is more effective in decreasing children’ BMI SD-score, improving eating and feeding behaviors and preventing metabolic disorders compared to standard care. Objectives The primary outcome is change in body mass index (BMI) z-score after 6-months and secondary outcomes include: waist circumference, HOMA-IR, fasting insulin, plasma triglycerides, total cholesterol, LDL cholesterol and HDL cholesterol, epigenetic (miRNA-221) and fecal SCFA/microbiota composition.
https://clinicaltrials.gov/ct2/show/NCT02721953?term=Roberto+Berni+Canani&draw=3&rank=15



 

Microbiota as target against food allergy (The MATFA study)
Study of the structure of the gut microbiome (shotgun gene sequencing) and of the function (complete metabolomic evaluation) for the development of new strategies for the prevention and treatment of allergy, starting from the understanding of the possible influence of the epigenetic mechanism.
https://clinicaltrials.gov/ct2/show/NCT02087930?term=MATFA&draw=2&rank=1



 

How junk food can contribute to the food allergy epidemic
Food allergy (FA) prevalence has dramatically increased in the last two decades. Based on current knowledge, the complex interaction between genetic and environmental factors may induce FA development in predisposed individuals. Among dietary factors, it has been hypothesized that advanced glycation endproducts (AGEs), present at high level in junk food, could be involved in FA pathogenesis. AGEs are a heterogeneous group of compounds deriving from sugars (sweets and beverages), autoclaved/processed foods, more roasted/barbecued meat. AGEs are ligands to the RAGE receptor and, mimicking signals provoked by tissue damage, are capable to activate mast cells and histamine release. The aim of our project is to evaluate the subcutaneous AGEs levels through the AGE reader and the correlation with dietary habit (foods-frequency questionnaires) in paediatric patients with challenge-proven FA, children with respiratory allergy (RA) and age and sex-matched healthy controls. Current hypotheses and models of FA do not adequately explain the dramatic increase observed in the last years. Dietary AGEs from junk food might be the missing link, and our data support this hypothesis.



 

Therapeutic effects of Bifidobacterium BB-12 in infants with infantile colic
https://clinicaltrials.gov/ct2/show/NCT03434249?term=Roberto+Berni+Canani&draw=2&rank=30



 

The preventive effects of postbiotic approach against infectious diseases in early childhood
https://clinicaltrials.gov/ct2/show/NCT02367612?term=Roberto+Berni+Canani&draw=2&rank=7



 

Effects of S.salivarius 24SMB and S.oralis 89a in allergic rhinitis
https://clinicaltrials.gov/ct2/show/NCT03449836?term=Roberto+Berni+Canani&draw=2&rank=20



 

PROPAD project: Probiotic Lactobacillus rhamnosus GG for Pediatric Atopic Dermatitis
https://clinicaltrials.gov/ct2/show/NCT03863418?term=Roberto+Berni+Canani&draw=2&rank=19



 

ATMA II study: Dietary Choice for the Management of Cow's Milk Allergy Influences Other Allergic Manifestations
https://clinicaltrials.gov/ct2/show/NCT03861910?term=Roberto+Berni+Canani&draw=2&rank=12



 

Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy
https://clinicaltrials.gov/ct2/show/NCT02081651?term=Roberto+Berni+Canani&draw=2&rank=17



 

Deciphering the protective role of Maternal Milk against Food Allergy: the pivotal role of Butyric Acid -in vivo and in vitro study
https://clinicaltrials.gov/ct2/show/NCT02301728?term=Roberto+Berni+Canani&draw=2&rank=31



 

EPICMA: Diet, gut microbiome and epigenetics as targets of intervention against cow’s milk allergy
https://clinicaltrials.gov/ct2/show/NCT04184700?term=Roberto+Berni+Canani&draw=2&rank=14



 

Diet, gut microbiome and epigenetics as targets of intervention against cow’s milk allergy



 

Diet and gut microbiome in pediatric autism spectrum disorders