Clinical trials: sponsored by Federico II University
Atopic Dermatitis
Probiotic Lactobacillus Rhamnosus GG for Pediatric Atopic Dermatitis
Atopic dermatitis (AD) is a multifactorial, chronic inflammatory skin disorder that results in areas of dry, itchy skin. AD affects up to 20% of children in Western societies and represents a prevalent, burdensome, and…
- Trial name
- PROPAD (NCT03863418)
- Testing
- Lactobacillus rhamnosus GG
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Cow Milk Allergy
Microbiota as Potential Target for Food Allergy
Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development.
- Trial name
- MATFA (NCT02087930)
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- Federico II University
Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy
Non-Immunoglobulin E-mediated Food Allergies in Children
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food…
- Conditions
- Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome
- Trial name
- NIGEFA (NCT04462978)
- Testing
- Non IgE-mediated food allergy
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Federico II University
Autism Spectrum Disorder
Impact of Nutritional Counselling in Children With Autism
Autism Spectrum Disorder (ASD) is a complex group of behavioral disorders characterized by defects in social interaction and communication associated with restricted and repetitive behaviors and activities.
- Trial name
- NCT04652388
- Testing
- Nutritional counseling
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
Obesity, Morbid, Metabolic Syndrome
The UFO (Ultra Processed Foods in Obesity) Project
The childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide.
- Trial name
- UFO Project (NCT05554016)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Federico II University
Peri-implant Mucositis, Mucositis Oral
Treatment of Peri-implant Mucositis by Application of a Spermidine-based Gel
The aim of the study is to evaluate the potential of a spermidine-based topical gel as an adjuvant to non-surgical treatment of peri-implant mucositis.
- Trial name
- NCT05926557
- Testing
- Spermidine gel, NSMD
- Where
- Italy
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Federico II University
Child Malnutrition, Child Allergy
The UFIM (Ultraprocessed Foods In Breast Milk) Project
In last decades, a change in dietary habits has been observed in industrialized countries characterized by a drastic increase in the consumption of ultra-processed foods (UPF, Ultra-Processed Foods).
- Conditions
- Child Malnutrition, Child Allergy, Maternal Exposure
- Trial name
- UFIM (NCT05889520)
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Federico II University
Food Allergy in Children
The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study
Non-specific lipid transfer proteins (nsLTPs) are currently recognized as the most prevalent cause of primary IgE-mediated food allergy in Mediterranean populations and constitute a leading trigger of anaphylactic reactions.
- Trial name
- NCT07105865
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Malnutrition
The SAM Project: Science Against Malnutrition Project
The latest data from the World Health Organization (WHO) shows that malnutrition in all its forms affects over 2.5 billion people globally.
- Trial name
- NCT06152848
- Testing
- Data and samples collection
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Federico II University
Atopic Dermatitis
The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis of Atopic Dermatitis in Pediatric Age
Atopic dermatitis (AD) is a common chronic inflammatory skin condition, primarily affecting children in urban and high-income areas.
- Trial name
- UPAD Project (NCT06996327)
- Testing
- Evaluation of dietary consumption of UPFs
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Allergy
Effects of the Direct Interaction Between Streptococcus Salivarius 24SMBc and Streptococcus Oralis 89a and the Respiratory Epithelium in Children
Allergic rhinoconjunctivitis is a pathology of the nasal and conjunctival mucosa induced by Immunoglobulin E (IgE) mediated inflammation following allergic exposure.
- Trial name
- NCT03449836
- Testing
- Streptococcus salivarius 24SMBc + Strept. oralis 89a, fluticasone + mometasone
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
Esophagitis, Eosinophilic
The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE) is a chronic antigen-mediated inflammatory disease of the esophagus that affects both children and adults.
- Trial name
- NCT06093204
- Testing
- Dietary evaluation
- Where
- 2 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Breastfeeding
The BuKoBc Project: Building a Deeper Knowledge on Breast Milk Composition
Breast milk is considered the gold standard for infant nutrition thanks to its ability to provide adequate nutrition and a high amount of protective factors for the baby's health.
- Trial name
- NCT06152835
- Testing
- Data and breast milk samples collection
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Allergies, Obesity
Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring
Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for…
- Conditions
- Allergies, Obesity, Gestational Complications, Gestational Weight Gain
- Trial name
- PREMEDI (NCT05119868)
- Testing
- Nutritional intervention based on Mediterranean Diet
- Where
- 2 sites in Italy
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Federico II University
Autism Spectrum Disorder
Probiotics for Autism Spectrum Disorders: a Randomized Controlled Trial (The PASD Study)
Autism spectrum disorders (ASD) are a group of severe neurodevelopmental conditions characterized by impaired communication and social interaction, as well as repetitive/stereotyped behaviors deriving from a combination of…
- Trial name
- PASD (NCT07345585)
- Testing
- Lactobacillus rhamnosus GG
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Federico II University
Blepharitis
Sterile Plant-Based Gauze for Eyelid Hygiene in Anterior Blepharitis
The goal of this clinical trial is to learn whether a sterile gauze containing natural plant extracts can lower the number of bacteria on the eyelid margin in people with bilateral anterior blepharitis.
- Trial name
- BLEPH-GAUZE (NCT07759180)
- Testing
- Plant-Based Sterile Eyelid Gauze, Sterile Cotton Gauze Moistened with Saline Solution
- Where
- Italy
- Volunteers
- 38 people
- Sponsor
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Peridontitis
This Study Evaluates the Clinical Effect of Adding Spermidine Gel to Minimally Invasive Non-surgical Periodontal Therapy (MINST) to Improve Periodontal Health.
This study investigates the effectiveness of using a spermidine-based gel as an adjunct to minimally invasive non-surgical periodontal therapy (MINST) for treating periodontitis.
- Trial name
- NCT06792916
- Testing
- spermidine and minimally invasive non surgical tecnique, peridontal therapy (minimally invasive non surgical tecnique)
- Where
- Italy
- Volunteers
- 13 people
- Sponsor
- Luca Ramaglia
Breast Cancer, Triple Negative Breast Cancer (TNBC)
Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer
The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2 + Breast Cancer
- Trial name
- NEOSHED (NCT07662252)
- Volunteers
- 186 people
- Sponsor
- Federico II University
Overweight and Obesity
Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status
This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut…
- Trial name
- ProPas (NCT04962633)
- Testing
- Probiotic Pasta, Control Pasta
- Where
- Italy
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Federico II University
Lifestyle-related Condition
Effects of Pulses Through the Gut Microbiome and Bioavailability of Bioactive Compounds
The goal of this clinical trial is to investigate the effects of replacing red meat with pulses, on cardiometabolic health and gut microbiome in individuals with unhealthy habits and sedentary lifestyles at high risk for…
- Trial name
- LEGUMINIBUS (NCT05999136)
- Testing
- Pulses diet, Plant proteins diet, Habitual diet
- Where
- Italy
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Paola Vitaglione