Clinical trials: sponsored by Federico II University
Arrhythmogenic Cardiomyopathy
Statin Effect on Arrhythmogenic Cardiomyopathy Disease Progression (SEARCH)
The goal of this clinical trial is to learn if Atorvastatin 80 mg is effective to avoid functional right ventricular deterioration in patients affected by Arrhythmogenic Cardiomyopathy.
- Trial name
- SEARCH (NCT06922994)
- Testing
- Atorvastatin 80 mg/day
- Where
- 5 sites in Italy
- Volunteers
- 102 people
- Sponsor
- Centro Cardiologico Monzino
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
Cystic Fibrosis (CF)
A Precision Medicine Approach to Assess Protein Function Loss and the Potential for CFTR Function Restoration in Cystic Fibrosis and Related Disorders
This multicenter translational research study integrates diagnostic analyses and ex-vivo functional testing to support future clinical trials evaluating the safety and efficacy of CFTR modulator treatments in individuals with…
- Trial name
- VALPERPRO-CFTR (NCT07889973)
- Where
- 3 sites in Italy
- Volunteers
- 165 people
- Sponsor
- Istituto Giannina Gaslini
Kidney Cancers, Prostate Cancer
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
The COMFORT study will evaluate an artificial intelligence-based platform developed to support the clinical assessment of kidney and prostate cancer.
- Trial name
- COMFORT (NCT07888322)
- Testing
- Medical Reading, AI assisted Medical reading
- Where
- 6 sites in Germany, Greece and 2 more
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Aristotle University Of Thessaloniki
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
Right Ventricular Dysfunction, Cardiopulmonary Diseases
Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
RIGHT-NET 2.0 is a multicenter observational study with a retrospective-prospective design that builds on the original RIGHT-NET study.
- Conditions
- Right Ventricular Dysfunction, Cardiopulmonary Diseases, Pulmonary Hypertension
- Trial name
- RIGHT-NET 2 (NCT07851610)
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- IRCCS SYNLAB SDN
Crohn Disease
Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
This is a three-arm, non-interventional observational study designed to investigate the relationship between Crohn's disease (CD), the microbiome, and diet in children.
- Trial name
- NCT04283864
- Testing
- endoscopy examination
- Where
- 8 sites in Canada, Croatia and 5 more
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Weizmann Institute of Science
Contraception
Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device With a Follow-up of 3 Years.
Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement.
- Trial name
- ReLARC - REL-0 (NCT05702281)
- Testing
- ReLARC
- Where
- Belgium
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University Hospital, Ghent
Chronic Kidney Disease on Hemodialysis, Physical Exercise Behavior (Liking/Aversion)
Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD)
The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis.
- Trial name
- Pehedal-ESKD (NCT07820514)
- Testing
- Intradialytic aerobic exercise using a cycle ergometer, Intradialytic elastic-band resistance exercise
- Where
- Italy
- Volunteers
- 312 people
- Sponsor
- Ricerca Nefrocenter
Obesity (BMI > 35) and Diabetes Mellitus, Obesity (BMI > 35) and Dyslipemia
Preoperative Optimization With Tirzepatide, Ketogenic Diet, or Standard Care Before One Anastomosis Gastric Bypass Surgery
This study compares three preoperative strategies before one anastomosis gastric bypass(OAGB) for severe obesity. Participants will be assigned to receive either tirzepatide medication for 60 days, a ketogenic diet for 4 weeks…
- Conditions
- Obesity (BMI > 35) and Diabetes Mellitus, Obesity (BMI > 35) and Dyslipemia, Obesity (BMI > 35) and High Blood Pressure
- Trial name
- OPTI-OAGB (NCT07622992)
- Where
- Italy
- Volunteers
- 96 people
- Sponsor
- Mario Musella MD
IgE-Mediated Cow Milk Allergy
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy.
- Trial name
- NCT07197814
- Testing
- Rice formula (New formula based on hydrolysed rice proteins)
- Where
- Italy
- Volunteers
- 29 people
- Sponsor
- Health and Happiness Research Limited
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