IBD (Inflammatory Bowel Disease)

Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD patients in clinical remission.

This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy. Participants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.

A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.

The primary objectives of this project are twofold: firstly, to evaluate the role of Maifu Changqing® Complete Nutrition Formula Powder in bowel preparation for colonoscopy in patients with IBD; and secondly, to enhance the nutritional support and comfort of bowel preparation for IBD patients.

The primary objectives of this project are twofold. On the one hand, it aims to investigate the current status of bowel preparation protocols and their quality in IBD patients undergoing colonoscopy, particularly focusing on the implementation of these protocols across hospitals following the release of the 2023 bowel preparation guidelines. This will further standardize and optimize bowel preparation practices in China. On the other hand, the project seeks to identify and examine various risk factors contributing to poor bowel preparation quality in IBD patients, analyze their correlation with bowel preparation scores, and develop a risk prediction model for failed bowel preparation. This will provide a theoretical foundation for formulating personalized bowel preparation regimens tailored to individual patient conditions in the future.

Children with Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), often face serious health challenges, including poor growth, frequent hospital stays, and long-term medication use. Although biologic drugs like infliximab, an anti-TNFα (Tumor necrosis factor α) medication, have improved treatment, they don't work for everyone: many children still experience symptoms or disease flare-ups. Nutritional therapies, especially the Crohn's Disease Exclusion Diet (CDED), may help improve treatment outcomes. This study will assess whether starting CDED at the same time as infliximab leads to better responses to treatment. The goal of this study is to improve how well children respond to therapy, reduce drug exposure, and support better long-term health.

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.

This is a monocentric, non-profit prospective cohort study with longitudinal biological sampling. The study will include patients with IBD starting biological therapy with infliximab. During four routine clinical visits in the induction phase (standard or accelerated) and the first maintenance visit, two saliva samples (pre- and post-infusion) and one plasma sample (pre-infusion) will be collected. Plasma samples will be obtained from leftover blood collected during routine clinical practice, with no additional blood draws required. The induction regimen (standard or accelerated) will be determined by the treating physicians based on the patient's clinical and laboratory characteristics and will not be influenced by study participation. The study focuses on the first four infliximab infusions (three induction and one maintenance). Standard induction lasts 14 weeks (infusions at weeks 0, 2, 6, and 14), while accelerated induction lasts 8 weeks (infusions at weeks 0, 1, 4, and 8). The primary objective of the study is to compare infliximab levels measured in plasma with infliximab levels in saliva in a sample of 15 patients receiving the drug during the first four infusions after a diagnosis of IBD. The study is purely exploratory, and the collected data will not be used for diagnostic or therapeutic purposes.

This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).

Title: The Role of Good Viruses in Inflammatory Bowel Disease Background An imbalance in the bacteria in the gut - called gut dysbiosis - is linked to chronic bowel diseases such as Crohn's disease and ulcerative colitis (IBD). A special and more severe form of IBD, called primary sclerosing cholangitis-associated IBD (PSC-IBD), affects both the gut and the bile ducts, and in serious cases can lead to liver failure. There is currently no cure for IBD. Research suggests that microorganisms in the gut, especially bacteria and viruses called bacteriophages, play an important role in how the disease develops. Treatment with stool from healthy donors, known as fecal microbiota transplantation (FMT), has proven effective against certain infections and has shown promising results in IBD. A newer and possibly safer method is fecal virome transplantation (FVT), where only the virus part (the gut virome) of the stool is used. Bacteriophages can kill harmful bacteria and help restore balance in the gut, but their use is still experimental. Therefore, we aim to develop a new treatment by growing bacteriophages from healthy individuals in the lab and using them to restore a healthy balance of bacteria and viruses in the gut of patients with IBD. Purpose of the study The long-term goal of the study is to improve treatment for IBD by gaining a better understanding of differences in the gut virome between IBD patients and healthy people. We also want to explore whether "fermented" bacteriophages from donor stool can be developed into a future bacteriophage-based therapy. This will be studied using experimental lab setups and animal models. The study will include 10 healthy stool donors and 30 IBD patients (10 with ulcerative colitis, 10 with Crohn's disease, and 10 with PSC-IBD). The study does not involve any treatments - only the collection of biological samples and access to information about your health from your medical record.

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.

screen for neurologic and psychiatric disorders in children and adolescents with 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 goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness/stress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC. Researchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores. Groups: 1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+/-2 weeks after the first intervention visit. 2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes). 3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes). 4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes). All subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, frequently presents with musculoskeletal extraintestinal manifestations (EIMs), such as arthritis and enthesitis, affecting up to 50% of patients. These can be subclinical and are often underestimated by physical examination alone. Musculoskeletal ultrasound (MSK-US) is a sensitive, non-invasive tool for detecting both clinical and subclinical inflammation. Despite its benefits, there is no standardized MSK-US protocol specifically for IBD patients. This study aims to develop a structured MSK-US assessment protocol, evaluate its effectiveness in detecting musculoskeletal involvement, and investigate its relationship with IBD disease activity.

The aim of this clinical trial is to gain a better understanding of the effect of Vitamin D supplementation on disease activity and overall health. The main questions it aims to answer are: 1. What proportion of IBD patients adhere to Vitamin D supplement recommendations over a 12-month period? 2. Is the ASK-12 Questionnaire valid in measuring adherence among IBD patients? 3. Does the severity of a patient's Crohn's disease effect overall adherence, over a 12-month period? 4. Does the severity of a patient's Ulcerative Colitis disease effect overall adherence, over a 12-month period? 5. Does Vitamin D supplementation affect the health-related Quality of Life for IBD patients? 6. Is 2,000 IU/Day an effective dose to sustain appropriate blood Vitamin D levels among previously Vitamin deficient IBD patients? Participants will: * Take 2000 IU of Vitamin D every day for the next 12 months * Complete 2 surveys, bloodwork and a fecal calprotectin test at the initial, visit, 6 month follow up and 12 month follow up

Inflammatory Bowel Diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic, disabling conditions affecting young adults, marked by flare-ups and remissions. Traditionally, IBD was treated with immunosuppressants like thiopurines, but new biological treatments, such as anti-TNFa antibodies (e.g., infliximab, adalimumab), have transformed management. Biologics often combine with thiopurines but come with risks, like increased chances of skin cancers and lymphomas, especially for prolonged use in young patients. Recently, newer biologics (e.g., ustekinumab, vedolizumab) and small molecules like JAK inhibitors have expanded treatment options. The exact cause of IBD remains unknown, though an inappropriate immune response to the intestinal microbiota in genetically predisposed individuals is suspected. Dysbiosis, or imbalance in gut microbiota, has been linked to IBD, with reductions in 'beneficial' bacteria and increases in harmful ones. Certain bacteria, like Faecalibacterium prausnitzii, may serve as markers for disease activity or progression. Due to the heterogeneity of UC and CD, it is crucial to identify early predictive factors for complications and treatment response. This study aims to identify biological markers of disease course and complications in IBD and to deepen understanding of its pathophysiological mechanisms.

The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. The main questions it aims to answer are: * Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy? * Does remimazolam allow faster recovery and discharge readiness compared to midazolam? Researchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency. Participants will: * Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy * Complete a short questionnaire to rate their satisfaction after the procedure * Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure

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.

The goal of this clinical trial is to evaluate if intensified omeprazole therapy can reduce high-output stoma (HOS) in adults undergoing ileostomy formation surgery. The main objectives of the study are: * To assess if intensified omeprazole treatment significantly reduces mean daily ileostomy output (ml/24h) during the first three postoperative days compared to standard omeprazole treatment. * To evaluate the proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml/day) on consecutive postoperative days. * To measure the time required for stabilization of ileostomy output (\<1400 ml/day maintained for three consecutive days). * To determine the incidence of dehydration-related complications, specifically electrolyte disturbances (hyponatremia, hypokalemia). * To compare the length of initial hospital stay, frequency of rehospitalizations within 30 days post-discharge, and total length of hospital stay (including rehospitalizations). Researchers will compare 10 days intensified omeprazole treatment (loading dose of 80 mg IV followed by 40 mg IV twice daily) with standard treatment (40 mg IV once daily) to determine the effectiveness of intensified dosing in reducing ileostomy output and improving postoperative outcomes. Participants will: * Receive either standard or intensified intravenous omeprazole during their hospitalization and after discharge for 10 days combined. * Undergo daily measurements of ileostomy output. * Have routine laboratory assessments of electrolyte levels. * Participate in follow-up assessments up to 30 days post-discharge, conducted either through outpatient visits or telephone consultations.

This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore \>1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore \>1; CDAI score ≤2 and no single subscore \>1) were used as the primary efficacy index.

This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.

Endoscopic scoring systems are vital for the objective assessment of disease activity being used in both clinical trials and daily clinical practice. These standardized scoring systems are essential for diagnosing, evaluating endoscopic healing, monitoring treatment response, and predicting clinical outcomes. One of the primary challenges in implementing these scoring systems is inter-observer variability, as highlighted by significant discrepancies between scores assigned by local and central reviewers. However, the performance of these systems among experts has been shown to be excellent, suggesting that achieving consistent and accurate scoring requires a high level of exposure and proficiency. Inconsistent scoring, especially among less experienced clinicians, poses a challenge to the reliability of these scoring systems. The primary objective of this study is to evaluate the improvement of scoring accuracy after training with structured educational videos with a specific focus on the learning curve and the practical application of endoscopic scoring systems.

The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients. The main questions it aims to answer are: Does abdominally targeted exercises can improve the quality of life of CD patients. Does abdominally targeted exercises positively influence clinical and biological responses in CD patients. Researchers will compare performing sets of special physical exercises designed for CD patients, compared to a control set of exercises ("generic" physical activity) to see if exercises designed for CD can result in an improved quality of life, in CD patients suffering from mild to moderate disease activity. Participants will: * Perform physical exercises designed for CD or control set of exercises every day for 8 weeks. * Visit the clinic once every 4 weeks for doctor visit, blood and stool test and filling out questionnaires.

Patients who will undergo surgery for HD after the diagnosis of IBD over a 12-month period will be enrolled across Europe. Primary objective of this study is to determine the safety and effectiveness of surgical treatments for HD in a large multicenter cohort of IBD patients. Secondary aim is to identify factors that may affect clinical and surgical outcomes.

Patients with IBD, both UC and CD, who fulfil the inclusion and exclusion criteria will be included consecutively: * Retrospective cohort Patients treated with IBD from January 2015 to June 2024 will be included. * Prospective cohort Consecutive patients with IBD who are starting, from clinical practice, new biological/small molecule therapies, failure (already exposed) to a mechanism of action (for anti TNF-alpha, more than one molecule is allowed), and who belong to the Lazio Regional Health System. Eligible subjects will be identified among patients belonging to the IBD Unit of the Digestive Diseases Centre (CEMAD) of the Foundation and to all the other IBD Units of all the centres specified in Annex 1. Based on the number of patients referred to the clinics, we estimate 112 patients per month, the time for recruitment is 24 months. Potential study participants will receive oral and written information about the study. Patients who agree to participate in the study will be asked to sign a written informed consent according to GCP.