Clinical Research Directory

Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease

Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present observational prospective study is aimed at investigating the effect of conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity/inflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).

Association of Diet and IBD

The study investigate the nutritional status and inflammatory markers and diet inflammatory index in patients with IBD and their effect on disease activity.

Acceptability, Adherence, and Impact on the Bioavailability of Iron and Zinc of the Dietary Supplements Goodphyte IB Defense and Goodphyte Immunity in Adults With Chronic Diseases.

The primary objective of the present postdoctoral research is to evaluate the acceptability and adherence of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity, in adult individuals with chronic diseases, namely Idiopathic Inflammatory Bowel Diseases (IIBD)-that is, Crohn's disease (CD) or Ulcerative Colitis (UC)-Arterial Hypertension (AH), Anemia (AN), or Multiple Sclerosis (MS). Secondarily, this study will investigate potential changes in iron and zinc absorption following phytase supplementation in these individuals and, consequently, possible changes in their quality of life.

Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.

Establishment of a Biological Collection to Develop Translational Preclinical Models for the Study of Tumors and Diseases of the Gastrointestinal Tract

The causes underlying the development of chronic inflammatory bowel diseases (IBD) and digestive cancers remain poorly understood. They involve both genetic susceptibilities and multiple environmental factors. Research and the development of new therapeutic strategies are essential to provide patients with novel treatment opportunities. A deep understanding of the tumor ecosystem at the molecular level, as well as the interactions between different cell types, is crucial to identify and validate new therapeutic targets. Since animal cancer models have shown their limitations in translating results to humans, studies models are often based on autologous patient tissues and sera. These innovative models make it possible to: * model tumors ex vivo, * perform screenings of new candidate molecules, * or test tumor response to existing therapies in the context of personalized medicine. This work has led to numerous publications on advanced digestive cancers, such as those of the liver or the bile acid pathway To create ex vivo models and reconstruct the tumor in vitro, experiments require treating tumor cells with blood from the same patient (autologous), collected simultaneously with the tumor resection. The tumor tissues used in culture are obtained from residual material of anatomopathological analyses performed as part of clinical care.

Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD

This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food-items that are high in added sugars, fats, and artificial ingredients. Participants will complete online food recalls to measure what they eat and will then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Researchers will compare changes in UPF intake between the two groups after several weeks and ask families how useful and acceptable they found the materials. The goal is to identify an effective, practical way to support healthier eating habits and long-term gut health in pediatric IBD.

Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA

This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers. IBD, including Crohn's Disease and Ulcerative Colitis, is associated with malabsorption, weight loss, sarcopenia, and malnutrition, which negatively impact quality of life and treatment outcomes. Nutritional assessment using the Malnutrition Universal Screening Tool (MUST) will identify patients at risk. Participants will be randomized to receive either nutritional counseling alone or counseling plus oral LH VIOLA supplementation (≥412 kcal/day) for 16 weeks. The primary objective is to evaluate maintenance or recovery of body weight at 16 weeks. Secondary objectives include assessment of weight at 24 weeks, muscle strength (handgrip), body composition and metabolic parameters (BIA/BIVA, vitamin B12/D, pre-albumin), quality of life (SF-12), economic impact, adherence, gastrointestinal tolerability, and reduction in malnutrition risk (MUST score). The study duration per patient is 24 weeks (16 weeks of intervention plus 8 weeks follow-up), with a total study duration of 18 months. The sample size is powered to detect an increase from 40% to 65% in patients achieving weight maintenance or gain at 16 weeks, accounting for a 15% dropout rate.

Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease

This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy

Impact of IBD Activity on Frailty in Patients Over 60 Years

The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years. The main questions it aims to answer are: 1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease? 2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources. The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission. Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.

Immunological Characteristics of Preclinical IBD

The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).

A Randomised Paired Design Study of Texture and Colour Enhancement Imaging (TXI) Versus High-definition White Light Endoscopy

Texture and Colour Enhancement Imaging (TXI) improves texture, brightness, and colour in white-light endoscopy to highlight subtle tissue differences. Now available through the EVIS X1 system, early evidence suggests potential value in IBD. Studies show that TXI may help predict ulcerative colitis relapse and performs comparably to dye chromoendoscopy in detecting lesions, though no randomised data exist for dysplasia detection in IBD surveillance. We therefore propose a randomised paired study comparing TXI with high-definition white-light endoscopy for dysplasia detection in IBD surveillance.

Exploring Fecal Calprotectin Levels, Maternal and Infant Microbiota, Infant Health, Nutrition, and Adverse Pregnancy Outcomes With Patient With Inflammatory Bowel Disease

The goal of this prospective longitudinal cohort study is to examine how the human microbiome of pregnant women-including bacteria and fungi in the gastrointestinal tract, vaginal canal, skin, and breastmilk-may influence infant gut inflammation, measured by fecal calprotectin (FCP) levels, and to identify factors that could inform dietary interventions to improve infant health outcomes. Specifically, the study aims to determine which maternal gut microbiome characteristics and dietary patterns during pregnancy are associated with elevated FCP levels in infants, and which infant gut microbiota compositions and dietary factors are linked to high FCP levels. Researchers will compare microbiome signatures and dietary factors in pregnant women and their infants with active or inactive IBD, as well as non-IBD controls, to identify microbial patterns that may predict infant gut inflammation. Participants will provide fecal samples at all study timepoints, one vaginal swab during the third trimester of pregnancy, and optional breastmilk and breast skin swab samples. They will also complete 3-day diet recalls using a smartphone app and participate in a longitudinal follow-up over 12 months after birth to monitor dietary patterns, microbiome profiles, and gut inflammation in both mother and infant.

Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) often leads to poor disease control and reduced quality of life. Changes in the gut microbiota may disrupt the energy metabolism of immune cells, contributing to IBD. This study will examine how gut microbiota affects immune cell metabolism in healthy adults and IBD patients. Healthy volunteers will be tested before and after a short antibiotic treatment, while IBD patients will be tested once. Energy metabolism will be measured using SCENITH, a method that analyzes metabolic activity in blood immune cells. Participants will also receive a special form of fiber (13C-labeled inulin) to track how gut bacteria break down and use this nutrient. Blood, urine, and stool samples will be analyzed to follow the metabolic fate of inulin. DNA and RNA from stool will be studied to identify which bacteria metabolize the labeled fiber.

The Assessment of Infrared Treatment for Crohn's Disease

The goal of this clinical trial is to test the safety and efficacy of far Infra-red (fIR) therapy in Crohn's disease patients. The main questions it aims to answer are: 1. Is infrared therapy safe for treating Crohn's disease patients? 2. Is infrared therapy effective for treating Crohn's disease? Participants will be asked to attend 10 treatments of fIR therapy, provide stool and blood samples and answer questionnaires. Researchers will compare between 4 treatments: three intensities of fIR therapy and placebo treatment to explore which intensity is most effective for treating Crohn's disease.

Validation of PET Questionnaire for Experience and Sustainability in Telemedicine. PET(Patient Experience in Telehealth)

Background: Telemedicine adoption has expanded rapidly in recent years, creating new opportunities for access to care, particularly for frail patients or those with mobility limitations. However, the large-scale deployment of remote healthcare services has highlighted the lack of validated instruments to systematically and multidimensionally assess patients' subjective experience. Patient experience is recognized as a key indicator of quality of care, with direct implications for treatment adherence, appropriate use of digital health technologies, and the effectiveness of organizational care models. Rationale: No instruments have been specifically validated in Italy to measure patient experience in telemedicine. In response, the Fondazione Policlinico Universitario A. Gemelli - Istituto di Ricovero e Cura a Carattere Scientifico (FPG IRCCS) developed, through a co-design process involving expert patients and healthcare professionals, the Patient Experience in Telehealth questionnaire (PET). The tool was designed to capture not only overall satisfaction, but also relational, informational, and organizational domains, as well as perceived economic and environmental impact. Objectives: The primary objective is psychometric validation of PET, assessing reliability and validity (construct, convergent, and discriminant). Secondary objectives include evaluating the perceived impact of telemedicine on care organization, patient-borne costs, and the environment, and exploring differences according to sociodemographic variables. Methods: This cross-sectional observational study will administer PET to at least 200 adult patients who received one or more telemedicine services at FPG IRCCS within the preceding three months. Content validity will be assessed by an expert panel. Descriptive analyses, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and reliability testing will be performed. A subgroup will complete a test-retest assessment after 7-14 days. Hypothesis: PET is expected to demonstrate satisfactory psychometric properties, discriminate across different levels of patient experience, and capture the perceived organizational, economic, and environmental impacts of telemedicine in healthcare delivery.

Pregnancy and Inflammatory Bowel Disease

Inflammatory Bowel disease, including Crohn's disease and Ulcerative Colitis, are chronic diseases. Diagnosis is most often done in women of childbearing age. IBD can have and increase the risk of intrauterine growth retardation, preterm birth… Conversely, pregnancy can have an impact on IBD activity during pregnancy. Moreover, IBD course can be influence in post-partum. The investigators will explore IBD course on 945 patients from the EPIMAD register. The investigators will cross the data on the IBD with data on pregnancy, postpartum but also breastfeeding. The principal aim of this study is to assess the number of flares during pregnancy.

Evaluation of the SMART IBD App in Pediatric IBD

The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in improving medication adherence and self-management skills in adolescents with IBD. The investigators will conduct a randomized control trial to compare 35 youth (ages 13-17) with IBD using an app that contains daily symptom diaries, education content, medication reminders, as well as monthly engagement challenges to 35 youth in an attention control group that will complete daily diaries. The length of the intervention will include one month of baseline symptom and adherence collection, a baseline assessment, 5 months of intervention, and a post-treatment assessment.

Texture and Colour Enhancement Imaging (TXI) Versus Dye Chromoendoscopy for Dysplasia Detection in IBD Surveillance.

In individuals with inflammatory bowel disease (IBD), bowel cancer can develop from abnormal cell changes (dysplasia). Regular colonoscopies are recommended to identify these early changes, which can be difficult to detect because they are often small and subtle. Dye-based imaging has been used to improve detection, but it requires additional preparation and time. Texture and Colour Enhancement Imaging (TXI) is a newer method available in clinical practice that adjusts brightness, colour, and texture on high-definition cameras. This study will compare TXI with dye-based imaging to assess which approach detects precancerous changes more effectively in patients with IBD.

Fluorescence Imaging of IBD and RA Using Adalimumab-800CW

Inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) are both auto-immune diseases that are characterized by chronic relapsing inflammation of respectively the ileocolonic tissue and the synovium. Pathogenesis of both auto-immune diseases is attributed to the proinflammatory cytokine tumor necrosis factor α (TNFa). Adalimumab is a human monoclonal anti-TNF antibody used for treating patients with moderate to severely active IBD and RA. However, current rates of therapeutic nonresponsiveness to this antibody are variable and difficult to predict in advance, whereas patients are potentially exposed to a non-effective treatment and its potential side effects; while clinical deterioration progresses. A key unmet need is the development of a predictive tool for assessment of a therapeutic (non-) response to patients and finding an optimal dose strategy in individual patients before initiating anti-TNF therapy. Unfortunately, we currently lack crucial information about drug distribution of the drug of interest throughout the targeted inflamed tissue itself. Therefore, it remains unknown in both IBD and RA, if the drug reaches its target (in sufficient amounts) and how local drug concentrations are related to therapeutic response. Thus, we linked adalimumab to a fluorescent dye (adalimumab-800CW) in order to create a fluorescent signal of the labelled drug in the diseased tissue that we can visualize and quantify with dedicated optical fluorescence imaging systems. We hypothesize that this tracer will bind to TNFa in the mucosa/synovium and thus create a map of medicine distribution in vivo due to colocalization of the fluorescent labelled compound. Therefore, the aim of this study is to assess the feasibility of fluorescent molecular imaging of adalimumab-800CW in IBD and RA patients.

Ex-vivo Confocal Imaging and Proteomic Profiling to Determine Treatment Response in Children With IBD

This study aims to test the overall hypothesis that the membrane tissue binding capacity of cytokines in the biopsied tissue of patients with Inflammatory Bowel Disease (IBD) is predictive of/strongly correlated to clinical response/outcomes observed. The key questions under investigation are: Aim 1: To assess the fluorescent signal intensity at baseline (control antibody with control biopsy and control antibody with IBD biopsy). Aim 2: To characterize the cellular landscape by surveying surface markers using bar-coded antibodies and performing gene expression profiling on every cell within inflamed tissue of patients with IBD. Aim 3: Develop algorithm using artificial intelligence to predict responders versus non-responders and to further subclassify IBD patients using phenotype data.

Vancomycin in Primary Sclerosing Cholangitis in Italy

Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications. This is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg/day) in subject between 15 - 70 years old with PSC.