[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Bari\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":300},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,47,75,107,134,163,191,218,243,272],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645231","emotional-allodynia-questionnaire-aeq-in-fibromyalgia-pearl-100645231",false,"NCT07677631","Emotional Allodynia Questionnaire (AEQ) in Fibromyalgia (PEARL)","Pain, Emotional Allodynia, and Relational Load (PEARL): A Multicenter Validation Study of the Emotional Allodynia Questionnaire in Fibromyalgia","PEARL","CASES (fibromyalgia)\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Clinical diagnosis of fibromyalgia confirmed according to the 2016 revision of the ACR criteria\n* Chronic non-cancer pain for at least 3 months\n* Ability to understand and independently complete self-report questionnaires in Italian\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Active oncological disease or cancer-related pain\n* Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder (assessed by clinical history)\n* Severe cognitive impairment precluding questionnaire completion\n* Inability to understand or complete questionnaires in Italian\n\nCONTROLS (non-fibromyalgia chronic pain)\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Chronic non-cancer pain for at least 3 months with a defined nociceptive or neuropathic generator (e.g., radiologically or surgically documented degenerative, structural, or post-surgical musculoskeletal pain, or neuropathic pain with an identifiable neurological lesion or disease)\n* Not meeting the 2016 ACR criteria for fibromyalgia\n* Ability to understand and independently complete self-report questionnaires in Italian\n* Willingness to provide written informed consent\n\nExclusion Criteria (parallel to cases):\n\n* Diagnosis of fibromyalgia or another recognized nociplastic primary pain condition (e.g., primary chronic widespread pain)\n* Active oncological disease or cancer-related pain\n* Any current or past psychiatric diagnosis except Major Depressive Disorder and Panic Disorder\n* Severe cognitive impairment precluding questionnaire completion\n* Inability to understand or complete questionnaires in Italian\n\nNote: ongoing pharmacological treatment for pain or mental health is not an exclusion criterion in either group; Major Depressive Disorder and Panic Disorder are recorded at baseline and used in covariate-adjusted and stratified analyses.","ALL","18 Years",{"count":20,"type":21},423,"ESTIMATED","OBSERVATIONAL","The Emotional Allodynia Questionnaire (AEQ) is an 11-item self-report instrument that measures disproportionate emotional reactivity to low-intensity interpersonal cues(perceived unresponsiveness, exclusion, loss of reciprocity), a pattern termed emotional allodynia. It was preliminarily validated in a single-center fibromyalgia sample. PEARL (validation phase) is a multicenter, prospective, observational psychometric validation study that (1) replicates the internal structure and convergent validity of the AEQ in an independent fibromyalgia sample, (2) tests its known-groups (discriminative) accuracy in separating fibromyalgia from non-fibromyalgia chronic pain of defined nociceptive or neuropathic origin, expressed as the area under the ROC curve (AUC), and (3) assesses test-retest reliability. There is no intervention.",[25,26,27],"Fibromyalgia","Chronic Pain","Nociplastic Pain",[29,25,30,31,32,33],"Emotional Allodynia Questionnaire","Nociplastic pain","Psychometric validation","Central sensitization","Emotion regulation","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":38},"2025-09-10",{"date":42,"type":21},"2027-08",{"name":44,"class":45},"University of Bari","OTHER",5,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":57,"studyType":22,"phases":4,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100639324","comparison-of-the-italian-and-us-forensic-models-for-dual-diagnosis-offenders-a-3-year-longitudinal-study-100639324","NCT07585656","Comparison of the Italian and U.S. Forensic Models for Dual-diagnosis Offenders: a 3-year Longitudinal Study","Comparison of the Italian and US Forensic Models Regarding Dual Diagnosis Offenders: a 3-year Longitudinal Study","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Individuals admitted to forensic psychiatric care in Italy or California.\n* Presence of a diagnosed mental disorder according to DSM-5 \u002F ICD criteria.\n* Presence of a current or lifetime Substance Use Disorder, consistent with a dual-diagnosis condition.\n* Placement in one of the study settings:\n\nItaly: REMS or other forensic\u002Fcommunity facilities under custodial or non-custodial security measures; California: Department of State Hospitals forensic facilities.\n\n* Ability to provide written informed consent, or consent provided through a legal guardian when applicable.\n* Availability for longitudinal follow-up at 12, 24, and 36 months.\n\nExclusion Criteria:\n\n* Absence of a confirmed psychiatric disorder.\n* Absence of current or lifetime Substance Use Disorder.\n* Non-forensic psychiatric patients without criminal justice involvement.\n* Severe cognitive impairment or neurological condition preventing valid assessment.\n* Acute medical or psychiatric instability that makes participation temporarily impossible.\n* Inability to complete the assessment procedures, even with support or adapted administration.\n* Refusal to participate or withdrawal of informed consent. Insufficient clinical, forensic, or follow-up data for longitudinal analysis.","75 Years",{"count":56,"type":21},600,"3 Years","This study aims to compare the Italian and U.S. forensic models in the treatment of offenders with dual diagnosis through a three-year longitudinal design. In Italy, the closure of Judicial Psychiatric Hospitals following Law 81\u002F2014 led to the establishment of a community-based forensic system centered on REMS (Residences for the Execution of Security Measures), integrated within the National Health Service. This model seeks to limit institutionalization and promote rehabilitative pathways in community settings. However, it continues to face challenges related to limited bed availability, waiting lists, and the complex management of social dangerousness. In contrast, the U.S. system, particularly in California, is characterized by high-security forensic psychiatric hospitals with large capacities, but also presents issues such as prolonged hospitalizations, an aging patient population, and a high prevalence of substance use disorders.\n\nDual diagnosis, defined as the co-occurrence of psychiatric disorders and substance use disorders, is highly prevalent in forensic populations and is associated with increased clinical complexity, higher risk of recidivism, and poorer treatment outcomes. Neurobiological and psychological mechanisms underlying addiction-including dysfunctions in the dopaminergic reward system, craving processes, and impairments in executive functioning-contribute to reduced behavioral control and increased impulsivity. Theoretical models such as the self-medication hypothesis and multifactorial frameworks suggest that substance use may both exacerbate psychiatric symptoms and represent an attempt to regulate them.\n\nGiven these complexities, integrated treatment approaches that combine psychiatric care and addiction interventions are essential, particularly in forensic settings. The present study includes offenders with mental illness in forensic care systems in Italy and California, encompassing both custodial and non-custodial settings. Participants will be followed over a three-year period, with assessments conducted at 12, 24, and 36 months. The methodology involves the use of standardized instruments to evaluate psychopathological severity, global functioning, risk of violent recidivism, protective factors, treatment adherence, impulsivity, and substance use. Data on clinical outcomes, antisocial behaviors, and discharge conditions will also be collected.\n\nThe primary objectives of the study are to describe and compare the clinical, demographic, and criminological profiles of forensic populations with dual diagnosis; to examine treatment pathways and outcomes; to identify indicators of treatment effectiveness; and to evaluate both risk and protective prognostic factors, as well as their predictive value for recidivism and clinical trajectories.\n\nThe expected impact of the study lies in improving the understanding of differences between community-based and hospital-based forensic models, with the goal of identifying integrated strategies capable of enhancing rehabilitation, reducing recidivism, and improving long-term outcomes. Findings may contribute to the development of more effective and individualized treatment approaches, as well as inform health and judicial policies aimed at better integrating clinical care and risk management in dual diagnosis forensic populations.",[60,61],"SCHIZOPHRENIA 1 (Disorder)","Substance Abuse",[63,64,65],"forensic treatment","SUD","forensic psychiatry","NOT_YET_RECRUITING","2026-05-06",{"date":69,"type":38},"2026-05-14",{"date":71,"type":21},"2026-06-01",{"date":73,"type":21},"2029-06-01",{"name":44,"class":45},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100523202","probiotics-to-actively-counter-ventilator-associated-pneumonia-proact-100523202","NCT06092554","Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)","Probiotics in ICU to Reduce Ventilator-Associated Pneumonia: A Double-blind Multicentre Randomized Clinical Trial","PROACT","Inclusion Criteria:\n\n* adults aged 18-80 years\n* at least one of the following conditions: a) recent trauma involving head injury and at least one more organ system; b) stroke or brain hemorrhage without any sign of aspiration and lung infection\n* intubation and start of mechanical ventilation. This needs to start immediately after the event described in the inclusion criteria (b). For cases of head trauma this is defined as start in the ambulance or the emergency department\n* likelihood that the duration of mechanical ventilation would be at least six days\n* written informed consent provided by the patient or legal representative\n\nExclusion Criteria:\n\n* has received mechanical ventilation more than 72 hours from start of screening\n* pregnancy or Lactation\n* patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes\n* HIV \\\u003C200 CD4 cells\u002FμL\n* those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2)\n* previous transplantation at any time\n* malignancy requiring chemotherapy in the last 3 months\n* neutropenia \\[absolute neutrophil count \\\u003C 500\\])\n* patients with a primary diagnosis of severe pancreatitis (Ranson score of 3 or more). Mild and moderate pancreatis is not excluded\n* ischemic bowel disease\n* oropharyngeal mucosal injury\n* inability to receive enteral medications\n* intent to withdraw advanced life support as per ICU doctor in charge\n* patients at risk of endovascular infection which includes\n\n  1. previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material \\[mechanical or bioprosthetic cardiac valves\\]\n  2. previous or current endocarditis\n  3. permanent endovascular devices (e.g., endovascular grafts \\[e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids\\] inferior vena cava filters, dialysis vascular grafts\n  4. tunnelled (not short-term) hemodialysis catheters\n  5. pacemakers or defibrillators\n\n     Patients with peripherally inserted central catheters (PICCs), temporary central venous catheters, central venous dialysis catheters, coronary artery stents, coronary artery bypass grafts (CABG), or neurovascular coils are not excluded, nor are patients with mitral valve prolapse or bicuspid aortic valve if they do not meet any other exclusion criteria.\n* patients with sepsis and\u002For septic shock","80 Years",{"count":85,"type":21},186,"INTERVENTIONAL",[88],"NA","PROACT study aims to resolve uncertainties to influence actual practice guidelines or public health policing regarding VAP prevention in ICU by using probiotics administration.\n\nMulti-trauma patients with a head injury OR stroke or brain haemorrhage patients without any sign of aspiration and lung infection will be enrolled and randomized to either placebo or probiotic treatment to assess if VAP and mortality can be reduced in the interventional group.",[91],"Ventilator Associated Pneumonia",[91,93,94,95,96,97],"Traumatic Brain Injury","stroke","probiotics","VAP","TBI","2025-09-17",{"date":100,"type":38},"2025-09-23",{"date":102,"type":38},"2023-12-13",{"date":104,"type":21},"2026-07-15",{"name":44,"class":45},9,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":115,"maxAge":18,"enrollmentInfo":116,"targetDuration":4,"studyType":86,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100602600","probiotic-mixture-l-rhamnosus-gg-and-l-plantarum-299v-in-pediatric-irritable-bowel-syndrome-100602600","NCT07125625","Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome","Randomized Double Blind Placebo Controlled Trial on a Probiotic Mixture (L. Rhamnosus GG Plus L. Plantarum 299V) in Pediatric Irritable Bowel Syndrome: Clinical Efficacy and Multiomics Approach","PRIME","Inclusion Criteria:\n\n* Children aged 4-18 years;\n* Irritable Bowel Syndrome according to Rome IV criteria\n* Average daily pain rate of at least 3 out of 10 VAS met during run-in period •-Written informed consent of parent's\u002Flegal tutor and verbal or written assent of the patient based on the minor's maturity\n\nExclusion Criteria:\n\n* Presence of other gastrointestinal diseases (inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease);\n* Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the study.\n* Primary or secondary immunodeficiency;\n* Malnutrition;\n* History of abdominal surgery in the past 3 months.;\n* Chronic or acute infectious diseases (viral, bacterial, parasitic) in progress;\n* Rome IV criteria diagnosis of functional constipation.\n* Use of probiotics\u002Fantibiotics within 4 weeks prior to enrolment;\n* Current pregnancy or breastfeeding;\n* Psychiatric conditions that reduce compliance with the protocol.","4 Years",{"count":117,"type":21},124,[88],"What is this study about? This clinical study aims to investigate whether a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition in children, causing abdominal pain, bloating, and changes in bowel habits (either diarrhoea, constipation, or alternating between the two). These symptoms can seriously affect a child's daily life and wellbeing.\n\nThe study is coordinated by the University of Bari, in collaboration with the University of Udine, and led by Prof. Ruggiero Francavilla.\n\nWhy is this study being done? Although probiotics are increasingly used in IBS, solid scientific evidence in children is still limited. This study will assess whether the chosen probiotic mix improves symptoms, bowel habits, and quality of life in young people with IBS. It will also investigate how the probiotics affect gut bacteria (microbiota) and the chemicals produced by the body (metabolomics), to better understand how these changes might help relieve symptoms.\n\nWho can take part? Children and adolescents aged 4 to 18 years with a diagnosis of IBS (based on international Rome IV criteria) who experience abdominal pain on a daily basis.\n\nChildren with other significant medical conditions, recent surgery, or ongoing infections, as well as those taking antibiotics or other probiotics shortly before the study, cannot participate.\n\nHow does the study work? The study is a randomised, double-blind, placebo-controlled trial, meaning that some children will receive the probiotic drops, and others will receive placebo drops (which do not contain probiotics), and neither the participants nor the doctors will know who is receiving which treatment. This is the best way to test whether the probiotics really work.\n\nEach participant will be involved in the study for about 14 weeks, divided into:\n\nA 2-week \"run-in\" period to confirm eligibility.\n\nAn 8-week treatment period (probiotic or placebo).\n\nA 4-week follow-up.\n\nThe probiotics\u002Fplacebo are taken as 20 drops once daily for 8 weeks.\n\nThroughout the study, children and parents will be asked to keep a daily diary of abdominal pain and bowel habits, and to complete validated questionnaires on symptom severity and quality of life. Stool and urine samples will also be collected at different time points to analyse changes in gut bacteria and body metabolism.\n\nWhat are the aims of the study?\n\nPrimary aim:\n\nTo see whether the probiotics reduce abdominal pain by at least 30% compared to the start of the study.\n\nSecondary aims:\n\nTo check if bowel habits improve (stool consistency and frequency).\n\nTo assess improvements in quality of life.\n\nTo analyse whether the probiotics cause positive changes in gut bacteria and metabolic profiles.\n\nTo ensure that the treatment is safe and well-tolerated.\n\nWhat are the possible risks and benefits? The probiotic mixture used in this study has been studied in children before and is generally considered safe. The study includes careful monitoring for any side effects.\n\nParticipants may or may not experience an improvement in symptoms. However, the information gained from the study will help doctors better understand how probiotics work in IBS and may benefit future patients.\n\nWhat are participants' rights? Participation is voluntary, and families may withdraw their child from the study at any time, without affecting the child's medical care. The study has been approved by an independent ethics committee and complies with all European and Italian regulations regarding research in children.\n\nAll personal data and medical information will be treated confidentially and securely, in accordance with privacy laws.\n\nWhere is the study taking place? The study is being conducted at the Paediatric Gastroenterology Unit of the University of Bari Aldo Moro and the Paediatric Unit of the University of Udine. These centres are national referral centres for children with gastrointestinal problems.\n\nWho is funding and organising the study? The study is sponsored and conducted by the University of Bari. The probiotic and placebo products are provided by Dicofarm S.p.A., who also ensures that the placebo and probiotic products look and taste the same to maintain the study's blinding.",[121],"Irritable Bowel Syndrome (IBS)",[123,95,124],"food supplement","irritable bowel syndrome","2025-08-13",{"date":127,"type":38},"2025-08-15",{"date":129,"type":21},"2025-09-01",{"date":131,"type":21},"2027-06-30",{"name":44,"class":45},1,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":86,"phases":146,"briefSummary":147,"conditions":148,"keywords":153,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":133},"100596839","efficacy-of-a-2-fucosylactose-based-food-supplement-on-the-prevention-of-respiratory-and-gastrointestinal-infections-100596839","NCT07050693","Efficacy of a 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections.","Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.","IMMUNOSICK24","Inclusion Criteria:\n\n* Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week\n\nExclusion Criteria:\n\n* Age less than 12 months and more than 48 months;\n* Concomitant presence of chronic diseases\n* Congenital heart disease;\n* Tuberculosis;\n* Functional gastrointestinal disorders;\n* Gastrointestinal or urinary surgery of the respiratory tract;\n* Autoimmune diseases;\n* Immunodeficiencies;\n* Chronic inflammatory bowel diseases;\n* Celiac disease;\n* Cystic fibrosis;\n* Metabolic diseases;\n* Lactose intolerance;\n* Tumors;\n* Chronic lung diseases and malformations of the gastrointestinal tract;\n* Food allergies;\n* Eosinophilic esophagitis;\n* Other hypereosinophilic diseases of the gastrointestinal tract;\n* Diarrhea at enrollment;\n* Severe malnutrition (z score for weight\u002Fheight less than 3SD);\n* Taking antibiotics and\u002For pre\u002Fpro\u002Fsymbiotics\u002Fimmunostimulants within 2 weeks of starting the study;\n* Breastfeeding in progress","12 Months","48 Months",{"count":145,"type":21},100,[88],"Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure of the respiratory and gastrointestinal tract still in development.\n\nFunctional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, sometimes with conflicting results. Some scientific evidence has shown that the administration of Vitamin D, Zinc, Beta glucan, 2'-Fucosyllactose can stimulate the immune defenses and reduce the number and severity of infectious episodes. In particular, 2'-fucosyllactose is one of the oligosaccharides of breast milk. It has both a prebiotic and immunoregulatory action since it is able to prevent the adhesion of pathogens to epithelial surfaces and subsequent translocation.\n\nHealthy school-going children aged between 12 and 48 months, who attend school at least 5 days a week, will be evaluated.",[149,150,151,152],"Gastroenteric Tract","Respiratory Tract","Infections","Gastroenteric Infections",[123,154],"gastroenteric infection","2025-07-03",{"date":157,"type":38},"2025-07-09",{"date":159,"type":38},"2025-04-17",{"date":161,"type":21},"2026-04-30",{"name":44,"class":45},{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":174,"conditions":175,"keywords":179,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":133},"100595759","intestinal-microbiota-after-ppi-treatment-100595759","NCT07036627","Intestinal Microbiota After PPI Treatment","Evaluation of the Intestinal Microbiota in Pediatric Patients Treated With Proton Pump Inhibitors: A Prospective Longitudinal Study","PPI","Inclusion Criteria:\n\n* Male or female children and adolescents aged between 6 months and 17 years at the time of enrollment.\n* Clinical indication for proton pump inhibitor therapy, including but not limited to gastroesophageal reflux disease, esophagitis, or functional dyspepsia.\n* Willingness and ability of the child and their caregivers to comply with all study procedures, including collection of fecal samples at scheduled time points.\n* Written informed consent obtained from a parent or legal guardian; assent obtained from the child, when age-appropriate, in accordance with local regulations and ethical standards.\n\nExclusion Criteria:\n\n* Use of systemic antibiotics, antifungals, or probiotics within 30 days prior to the start of the study or during the observation period.\n* Incomplete or improperly handled stool sample collection, or failure to adhere to protocol-defined sampling windows.\n* Known diagnosis of primary immunodeficiency, inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), or celiac disease.\n* Any condition that, in the opinion of the investigator, may interfere with the integrity of the study or pose additional risks to the participant.","6 Months","17 Years",{"count":145,"type":21},"This clinical study aims to investigate the effects of short-term treatment with proton pump inhibitors (PPIs) on the gut microbiota of pediatric patients. PPIs are among the most frequently prescribed medications in children and adolescents for the management of acid-related disorders, such as gastroesophageal reflux disease (GERD). However, emerging evidence suggests that these medications may have unintended consequences on the delicate ecosystem of beneficial microorganisms residing in the human gastrointestinal tract.\n\nThe intestinal microbiota plays a pivotal role in modulating immune responses, supporting nutrient metabolism, and maintaining the integrity of the gut barrier. Disruption of this microbial balance-known as dysbiosis-has been associated with several health conditions, including infections, allergies, obesity, and chronic inflammation. In adults, long-term PPI use has been linked to microbiota alterations, but data in the pediatric population remain limited and inconclusive.\n\nTo address this gap, our prospective longitudinal study will recruit pediatric patients prescribed PPI therapy for clinical indications. Stool samples will be collected at four time points: prior to PPI administration, during treatment, and at two follow-up stages post-cessation. Using 16S rRNA gene sequencing, we will profile changes in microbial diversity and abundance over time.\n\nThe results will offer insight into whether short-term PPI exposure in children leads to significant, lasting changes in gut microbiota composition or diversity. Such information may ultimately inform prescribing practices, support personalized therapeutic strategies, and help mitigate potential risks associated with microbiota disruption during childhood-a critical period for microbial and immune system development.",[176,177,178],"Proton Pump Inhibitors","Human Gastrointestinal Tract","Gastroesophageal Reflux Disease",[169,180,181,182],"GERD","microbiota","gastroesophageal reflux","2025-06-25",{"date":185,"type":38},"2025-06-29",{"date":187,"type":21},"2025-07-06",{"date":189,"type":21},"2027-02-01",{"name":44,"class":45},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":133},"100595469","intestinal-permeability-in-children-with-autism-spectrum-disorder-100595469","NCT07032857","Intestinal Permeability in Children With Autism Spectrum Disorder","Breaking Barriers: A Clinical Experimental Study of Intestinal Permeability in Children With Autism Spectrum Disorder","IP-ASD","* Children with a clinical diagnosis of ASD according to DSM-IV, confirmed by ADOS-G.\n* Consumption of a gluten-containing diet.\n* Negative celiac disease serology (EMA and anti-TG2 IgA antibodies).\n* Absence of IgE- or non-IgE-mediated food allergies.\n\nExclusion Criteria:\n\n* Known neurological disorders.\n* Major congenital anomalies.\n* Severe head trauma.\n* Chronic gastrointestinal diseases.\n* Special diets (e.g., gluten-free or gluten\u002Fcasein-free).\n* Antibiotic or probiotic\u002Fprebiotic intake in the previous 4 weeks.","2 Years","14 Years",{"count":202,"type":21},55,"In recent years, increasing attention has been directed toward the role of the gut-brain axis in the pathogenesis of neurodevelopmental disorders, particularly Autism Spectrum Disorder (ASD). Among the multiple contributing factors, the integrity of the intestinal barrier appears to play a crucial role. Enhanced paracellular permeability (\"leaky gut\") may allow luminal antigens and microbial metabolites to translocate into the systemic circulation, triggering inflammatory responses that could impact neuropsychological functioning.\n\nSeveral studies suggest that, although intestinal permeability is not universally altered in all individuals with ASD, there exists a subset characterized by selective epithelial dysfunction, especially associated with repetitive and stereotyped behaviors.\n\nThis project aims to investigate, through a controlled sibling-based design, whether intestinal permeability indices are significantly altered in children with ASD and whether such alterations are specifically correlated with behavioral domains assessed through the ADOS instrument.",[205],"Autism Spectrum Disorders",[207,208,209],"autism spectrum Disorders","Intestinal permeability","Leaky gut","2025-06-24",{"date":212,"type":38},"2025-06-27",{"date":214,"type":38},"2023-01-01",{"date":216,"type":21},"2025-09-30",{"name":44,"class":45},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":225,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":86,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":133},"100591457","ozonized-olive-oil-in-the-treatment-of-periodontal-pockets-100591457","NCT06980675","Ozonized Olive Oil in the Treatment of Periodontal Pockets","Clinical and Microbiological Study on Local Application of an Ozonated Olive Oil Gel in the Periodontal Pockets: a Randomized Double-blind Trial.","Inclusion Criteria:\n\n* Patients with stage II, III, or IV periodontitis according to the new 2017 World Workshop periodontal classification\n* Patients of either sex and older than 18 years of age\n* Probing Pocket Depth (PPD) greater than or equal to 4 mm at 3 sites\n* Patients who have signed consent to the study\n* Collaborating patients\n\nExclusion Criteria:\n\n* age \\\u003C 18 years and\u002For inability to provide written informed consent;\n* absence of family or social welfare support;\n* non-drug-induced gingival hypertrophy,\n* severe smokers (more than 20 cigarettes per day),\n* consumers of high levels of alcohol,\n* patients on corticosteroid treatment,\n* diabetic patient,\n* immunodepressive therapies,\n* chemotherapies,\n* radiotherapies,\n* pregnancy states;\n* lack of collaboration for ongoing postoperative reevaluations.",true,{"count":227,"type":21},20,[88],"A randomized controlled clinical trial was conducted on 16 patients (8 males and 8 women) who were diagnosed chronic periodontitis. All the patients has been divided by randomization in two groups: control group treated with placebo gel and experimental group treated with gel based on ozonated EVO olive oil.\n\nBoth group after the evaluation of inclusion and exclusion criteria during the first visit, were subjected to hygiene treatment of removal tartar deposit, considered as standard of therapy for periodontitis.\n\nAfter 15 days the hygiene treatment, patients were been randomized in two groups following the flow chart (t0) starting with: periodontal probing, microbiological samples and the first administration of gel. Next week (t1), has been collected the compliance and did the second administration of gel; the procedures will be the same also for another week (t2), until the last week (t3) when has been registered the second periodontal probing and did the second microbiological samples.\n\nData were collected to software Microsoft Excel and all the data analysis were conducted on this software to highlight significant differences between both groups. As the primary outcome was continuous variable and assuming normal distribution bilateral parametric test T-student was performed. An alpha error of 5% was considered, Beta error was not calculated as this was a pilot study.",[231],"Periodontal Pocket",[233,231,234],"Ozonated Olive Oil","Periodontal Disease","2025-05-16",{"date":237,"type":38},"2025-05-20",{"date":239,"type":38},"2021-10-25",{"date":241,"type":21},"2025-05",{"name":44,"class":45},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":225,"sex":17,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":86,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100575063","a-multi-domain-intervention-for-healthy-aging-100575063","NCT06767410","A Multi-domain Intervention for Healthy Aging","A Multi-domain Intervention to Constrast Cognitive Decline in Healthy Aging","MultiMusic","Inclusion Criteria:\n\n* Age ≥ 65\n* Living independently\n\nExclusion Criteria:\n\n* Musical expertise\n* Severe cognitive or functional impairment","65 Years",{"count":145,"type":21},[88],"This study aims to investigate the long-term impact of a non-pharmacological intervention including several activities (e.g., physical activity, choir, learning programs, horticulture, etc.) to prevent cognitive impairment in community-dwelling elderly individuals with aspects of frailty. The main questions it aims to answer are:\n\n* Does engaging in multiple activities, including music, slow the degeneration of perceptual and cognitive functions?\n* Is it possible to foster beneficial brain changes even during aging?\n* Can regularly attending social contexts reduce the risk of loneliness and provide fulfillment in later life? Researchers will compare participants involved in the multidomain intervention, including music, to another active group carrying out several activities but without music, and to a passive control group.\n\nParticipants will:\n\n* Participate in the programs for 9 months;\n* Be tested three times (before and after the intervention, and at a 6-month follow-up);\n* Keep a weekly diary of the actual time spent in their activities.",[256],"Healthy Volunteer Study",[258,259,260,261,262],"BDNF","aging","multidomain intervention","music training","neuroplasticity","2025-01-05",{"date":265,"type":38},"2025-01-09",{"date":267,"type":21},"2025-10-01",{"date":269,"type":21},"2027-12",{"name":44,"class":45},4,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":17,"minAge":142,"maxAge":200,"enrollmentInfo":279,"targetDuration":4,"studyType":86,"phases":281,"briefSummary":282,"conditions":283,"keywords":287,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":133},"100476453","lactobacillus-reuteri-strain-combination-in-children-treated-with-ppi-100476453","NCT05484128","Lactobacillus Reuteri Strain Combination in Children Treated With PPI","Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors","Inclusion Criteria:\n\n* Age: children between 1 month and 14 years of age;\n\n  o We start with children older than 4 years of age.\n* Necessity of therapy with Proton Pump Inhibitors for Gastroesophageal reflux disease and\u002For Functional Dyspepsia;\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Neurological pathologies (PCI and Spastic tetra-paresis);\n* Nasogastric feeding;\n* Known immunodeficiency;\n* Previous therapy with gastric acid inhibitors;\n* HP infection;\n* Assumption of prebiotics, other probiotics or symbiotics in the previous month;\n* Malnutrition or severe dystrophy;\n* Cystic Fibrosis.",{"count":280,"type":21},172,[88],"Probiotics might be of help in preventing dysbiosis and emergence of SIBO. Gastrus consisted of a mixture of two human strains of L. Reuteri DSM 17938 and ATCC PTA 6475; the first have extensive data supporting its use in gastric infections (18) however, it lacks the anti-inflammatory properties that have been provided by L. Reuteri DSM ATCC PTA 6475 that has excellent acid resistance and has strong anti-inflammatory properties (19); for these reasons, Gastrus is the best candidate for this indication.",[284,285,286],"Gastric Lesion","Proton Pump Inhibitor Adverse Reaction","Probiotic",[288,289,290,291],"Reuteri","Proton Pump Inhibitor","gastrus","infections","2024-12-03",{"date":294,"type":38},"2024-12-05",{"date":296,"type":38},"2020-03-04",{"date":298,"type":21},"2025-12-31",{"name":44,"class":45},""]