Clinical trials: sponsored by Federico II University
Infantile Colic
The Effect of Probiotics in Infantile Colic
Academic, independent, non-commercial, multicenter study sponsored by the Department of Translational Medical Sciences (DISMET), University of Naples Federico II.
- Trial name
- CSUB0214 (NCT07894445)
- Testing
- Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Federico II University
Gastrointestinal Health
The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
This study aimed to evaluate whether daily postbiotic supplementation could improve gastrointestinal well-being and influence physiological and metabolic parameters in healthy young adults.
- Trial name
- PIProBaTo-II (NCT07893301)
- Testing
- Postbiotic Supplement
- Where
- Italy
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Federico II University
Kidney Transplantation, Kidney Transplantation Recipients
Effect of Probiotics on Immunosuppressant Therapy in Kidney Transplant Recipients
People who receive a donor kidney must take drugs to prevent their bodies from attacking the new organ. These drugs are called immunosuppressants. Probiotics are beneficial microbes that support gut health.
- Trial name
- PITON (NCT07884084)
- Testing
- Probiotic formulation
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Federico II University
Overweight Adults
Effects of a Sugar-Based Synbiotic Product on Cardiometabolic and Intestinal Health (SUGAR-SYN BC3O)
This randomized, double-blind, controlled, crossover study investigates the effects of a sugar-based synbiotic product containing inulin and Bacillus coagulans BC30™ spores in healthy overweight individuals.
- Trial name
- SUGAR-SYN BC3O (NCT07806383)
- Testing
- Sugar-Based Synbiotic Product, Inulin-Containing Sugar Product
- Where
- Italy
- Volunteers
- 20 people, healthy volunteers welcome
- 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
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
Cow's Milk Allergy
Epigenetic Effects Elicited By Lactobacillus GG In Children With Cow's Milk Allergy
Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic disorders. We have shown that Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk allergy (CMA).
- Trial name
- NCT02062476
- Testing
- Lactobacillus GG
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Federico II University
Oral Leukoplakia, Autofluorescence
Identification of Oral Lesions Through an Autofluorescence System
The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa.
- Conditions
- Oral Leukoplakia, Autofluorescence, Secondary Prevention, Keratosis
- Trial name
- NCT05942794
- Testing
- Screening examination
- Where
- Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Federico II University
Food Allergy
The Quality of Life of Mothers of Children With Food Allergy
Food allergy (FA) derives from an abnormal immunological response to dietary antigens. On the basis of the immunological mechanism, FA are divided into the following forms: IgE-mediated, non-IgE-mediated and mixed.
- Trial name
- NCT04740632
- Testing
- Personalized Nutritional Counseling by a multidisciplinary team
- 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
Periodontal Bone Loss
Application of Hyaluronic Acid in the Treatment of Periodontitis
The aim of the present investigation will be evaluated the healing of suprabony defects following surgical flap elevation and hyaluronic acid application respect to surgical flap elevation alone.
- Trial name
- NCT05073575
- Testing
- Hyaluronic acid, No-hyaluronic acid
- Where
- Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- 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
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
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
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
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