Clinical trials: sponsored by 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
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
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
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
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
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
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
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
Sebum Production, Acne Scars
SMosE Safety and Efficacy Evaluation as a Skin Adaptogen
This study evaluates the biological activity, safety, and clinical efficacy of SMosE (Shiitake Mushroom Oil-Soluble Extract), a topical cosmetic ingredient developed to support skin barrier function, adaptogenic responses, and…
- Conditions
- Sebum Production, Acne Scars, Skin Barrier to Water Loss
- Trial name
- SMosE (NCT06338046)
- Testing
- Corthellus Shiitake(Mushroom) Extract
- Where
- Italy
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Federico II University
Diabetic Retinopathy, DR
Epivascular Glia Regression and Macular Pigment Restoration After Faricimab in Diabetic Retinopathy
The aim of the study is to evaluate in diabetic patients affected by diabetic retinopathy epivascular glia regression and macular pigment restoration after faricimab injection in diabetic retinopathy in a 1 year follow up
- Trial name
- GLIA-MAC (NCT07526857)
- Testing
- Faricimab Injection [Vabysmo], Aflibercept (2.0 mg)
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Federico II University
Peri-implant Mucositis, Mucositis Oral
Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis…
- Trial name
- NCT05926297
- Testing
- Application NaOCl gel + HA gel, Non-surgical mechanical debridement
- Where
- 2 sites in Hungary, Italy
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Federico II University
Glycemic and Insulinemic Response, Type 1 Diabetes (T1D)
Glycemic Response to Carbob-Enriched Pasta in Healthy and With Type 1 Diabetes People
Carob (Ceratonia siliqua) is a fruit traditionally used in various Mediterranean countries for the preparation of sweets and beverages.
- Trial name
- GR-CEP (NCT06994403)
- Testing
- Durum wheat pasta enriched with carob flour, Standard durum wheat pasta, White bread reference meal
- Where
- Italy
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Federico II University
Stage 3 AMD
Lutein by Scleral Iontophoresis in AMD
The objective of the clinical investigation is to evaluate the performance, safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 (AREDS…
- Trial name
- NCT06925893
- Where
- Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Federico II University
Migration of Implant or Internal Device
Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter.
This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval…
- Trial name
- DISLOTIP (NCT06438289)
- Where
- Italy
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Federico II University
Diabetes, Pre-diabetes
Effect of Oral L-arginine 3.32 g a Day on Oxidative Stress Influencing Beta Cell Function and Insulin Resistance.
The objective of this clinical trial is to explore whether L-arginine supplementation with 3.32g/day may enhance antioxidant defenses in overweight and obese patients with pre-diabetes and metabolic syndrome, possibly providing…
- Conditions
- Diabetes, Pre-diabetes, Metabolic Syndrome
- Trial name
- L-BIOARG (NCT06686069)
- Testing
- bioarginina zero
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Federico II University
Ischemic Heart Disease, Heart Failure
SNORD3A IN ISCHEMIC HEART DISEASE AND HEART FAILURE
This is a prospective, non-randomized, single center, open label clinical study enrolling patients affected by 1) chronic ischemic heart disease with evidence or suspect significant myocardial ischemia (group 1, CCS) or 2) acute…
- Trial name
- SENSITISE (NCT06678802)
- Testing
- Blood sampling
- Where
- Italy
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Federico II University
Allergy, Cow's Milk Allergy
Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy
Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to…
- Trial name
- NIQA (NCT06134466)
- Testing
- Liquid Extensively hydrolyzed cow's milk protein infant formula
- Where
- Italy
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Federico II University
Endometrial Cancer, Endometrial Diseases
Virtual Reality's Role in See&Treat Hysteroscopy
The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \& treat philosophy.
- Conditions
- Endometrial Cancer, Endometrial Diseases, Myoma;Uterus, Endometrial Hyperplasia
- Trial name
- NCT06524934
- Testing
- Use of virtual reality during the hysteroscopic procedure
- Where
- Italy
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Federico II University
Cataract, Macular Edema
The Role of Radial Peripapillary Vessel Density in Irvine-gass Syndrome
Pseudophakic cystoid macular edema (PCME), also known as Irvine-Gass syndrome (IGS), is an accumulation of fluid in the macula that occurs after cataract surgery, with an early or late presentation (cut-off 3 months) .
- Trial name
- OCTA and PMCE (NCT06436170)
- Testing
- OCTA
- Where
- Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Federico II University
Macular Degeneration Choroidal Neovascularization
Deep Learning Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) in NVC
To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A using a split-person study design and deep-learning quantification.
- Trial name
- OCTA (NCT05969418)
- Testing
- Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Federico II University