Research institution
Federico II University Clinical Trials
Studies where Federico II University is the lead sponsor: what is enrolling now, by phase, condition and country.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 40Infantile 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
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
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
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
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
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
Sacroiliitis, Low Back Pain
Neurolyser XR for the Treatment of Sacroiliitis
Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis.
- Trial name
- NCT07647757
- Testing
- Patients treated with high intensity focused ultrasound
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Federico II University
Glycogen Storage Disease Type I
Use of Continuous Glucose Monitoring to Evaluate Postprandial Response to Raw Cornstarch Supplementation in Adult Glycogen Storage Disease Type I
The aim of this observational study is to evaluate the impact of raw cornstarch supplementation on postprandial glycemic response in adult patients with Glycogen Storage Disease type I (GSD I), using continuous glucose monitoring…
- Trial name
- NCT07645898
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Federico II University
Breast Cancer, HER2 Negative Breast Cancer
Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)
Background and Purpose: Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life.
- Conditions
- Breast Cancer, HER2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- SDM-01 (NCT07578415)
- Testing
- Shared Decision Making (SDM) Support Program
- Volunteers
- 120 people
- Sponsor
- Federico II University
Type 2 Diabetes
Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy
CardioMET is an observational, multicenter, real-life registry, intending to collect data on patients with Type 2 Diabetes Mellitus, attending internal medicine and cardiology outpatient clinics.
- Trial name
- CardioMET (NCT07375069)
- Testing
- data collection
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Federico II University
Completed, with results posted
All 5Infantile Colics
Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics
A multicenter prospective, randomized comparative study will be conducted in infants with colic, according to Rome III criteria. Enrolled infants will be assigned at random to receive Chamomilla L., Melissa Officinalis L.
- Trial name
- NCT02708238
- Testing
- Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), Lactobacillus reuteri DSM 17938 (108 CFU), Simethicone
- Volunteers
- 180 people
- Sponsor
- Federico II University
Metabolic Syndrome
Wholegrain Cereal Diet and Insulin Sensitivity
A diet with the multiple beneficial characteristics of whole grains and, more in general, of "healthy cereals" favorably influences glucose and insulin metabolism in subjects with metabolic syndrome.
- Trial name
- NCT00945854
- Testing
- Wholegrain cereal diet, Refined cereal diet
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
Heart Failure, Growth Hormone Deficiency
Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.
- Conditions
- Heart Failure, Growth Hormone Deficiency, Ischemic Heart Disease
- Trial name
- NCT00591760
- Testing
- Somatotropin
- Volunteers
- 56 people
- Sponsor
- Federico II University
Healthy
Physiological Effects of New Polyphenol-enriched Foods in Humans
Polyphenolic compounds exert several health benefits depending on bioavailability. Encapsulation may improve bioavailability of these compounds.This study will evaluate bioavailability of some polyphenols (curcumin and cocoa…
- Trial name
- NCT01288859
- Testing
- free curcumin, encapsulated curcumin, encapsulated curcumin + PQG
- Where
- Italy
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Federico II University
Acute Myocardial Infarction
Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
This purpose of this study is to examine the relationship between HMGB-1 and postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based cardiac…
- Trial name
- NCT00755131
- Testing
- Exercise-based Cardiac Rehabilitation program
- Where
- Italy
- Volunteers
- 75 people
- Sponsor
- Federico II University