
Dietary Intervention for Inflammatory Bowel Disease Remission
Inflammatory Bowel DiseasesTo compare adding dietary intervention based on MD to dietary intervention based on IBD-AID on induction of disease remission of IBD patients receiving pharmacotherapy. To compare patients' adherence to dietary intervention based on MD to dietary intervention based on IBD-AID, and the impact of adherence on induction of remission among patients with IBD receiving pharmacotherapy.

Pilot Study for the Evaluation of Food Choices in Patients With Inflammatory Bowel Diseases (MICI2021)...
Inflammatory Bowel DiseasesThis project is a pilot study exploring the effects of dietary choices and quantitative digestion of gluten ingested by individuals with IBD compared to a control population. The aim of the study is to evaluate for the first time in an Italian population of subjects with IBD the presence of a diet based on GFD (gluten free diet).

A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory...
Inflammatory Bowel DiseaseA Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 18 years from birth.

Predictors of Prognosis in IBD Patients
Inflammatory Bowel DiseasesUlcerative Colitis1 moreA study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation
Fontan OperationProtein-Losing Enteropathy1 moreThis study is phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of Camostat mesylate in patients with Protein-losing enteropathy after Fontan operation.

Clinical Utility Evidence for TissueCypher®
Gastro-Intestinal DisorderBarrett EsophagusCernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. The data from this study will be provided to all participating physicians and submitted to a national journal for publication. The study plans to enroll up to 249 physicians.

Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease
Inflammatory Bowel DiseasesIrritable Bowel SyndromeActive inflammatory bowel disease (IBD) causes disabling symptoms such as diarrhea, involuntary loss of bowel control, abdominal pain and urges to pass stool. However, even patients with inactive IBD frequently experience such symptoms. The cause is not well understood and the functionality of the bowel in IBD patients is underexplored. Earlier studies show a wide range of results, but most find that patients with IBD in remission are up to four times as likely to report gastrointestinal symptoms when compared to healthy controls. Chronic inflammation may cause changes of the bowel wall, like increased collagen deposits (fibrosis) and thus cause symptoms, but the absence of active inflammation in combination with presence of symptoms may also be regarded as resembling the clinical condition of irritable bowel syndrome (IBS). IBS is characterized by abdominal pain and changes in stool frequency and consistence and is often associated with disorders like depression and anxiety. Up to a third of IBD patients without signs of disease activity meet the criteria for IBS (irritable bowel syndrome. It can be speculated that an IBD diagnosis is a distressing event that can induce mood disorders, and an IBS-like condition. Characterization of IBS patients relies on the Rome IV symptom criteria, symptom severity scales and measurements of rectal sensibility and rectal compliance using a barostat procedure. Motor function assessment relies on anorectal manometry which detects abnormalities of muscle function and coordination. Recently, a standardized high-resolution anorectal manometry protocol (HRAM) was published which also evaluates sensitivity and compliance. The level of agreement between the barostat method and the HRAM testing procedure regarding sensibility and rectal compliance is largely unknown. Recent studies have associated gut microorganisms, genetic factors, and proteins with various aspects of IBD. There is evidence that these potential markers may reflect non-inflammatory processes such as fibrosis. The aim of this study is to explore the anorectal function in symptomatic patients with inactive IBD compared to healthy volunteers and asymptomatic patients, evaluate symptom severity and psychological parameters and perform molecular characterization. The level of agreement of rectal sensitivity and compliance measurements with the barostat method and HRAM protocol will also be evaluated.

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel...
Inflammatory Bowel DiseasesCrohn's Disease2 moreTARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Comparison of Trough Level- and Clinical-based Spacing of Infliximab Infusions in Patients With...
Inflammatory Bowel DiseasesComparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study

Mechanism of Chronic Pain in Patients With IBD
Inflammatory Bowel DiseasesAbdominal pain is a common symptom in patients with inflammatory bowel disease (IBD). Up to 70 % of IBD patients experience pain when the disease is active. Even when patients with IBD are in remission, 20-50 % experience ongoing pain. The precise mechanism of developing chronic abdominal pain in patients with IBD in remission remains unknown. The aim of this study is to identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed IBD (ulcerative colitis and Crohn's disease). This study consists of 4 sections (Study 1A, 1B, 2, and 3): Study 1A: We perform a longitudinal study in 150 patients with new-onset IBD over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain. This is a collaborative study with IBD BioResourse Inception study. We administer online questionnaires, collect stool and blood samples, and record heart rate. Other physiological data collected by the Inception study will be also used for the analysis. Study 1B: This is also a collaborative study with the Inception study. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients (n=450) that are included in the Inception study on a voluntary basis. Patients will be followed for 12 months. Study 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD. The participants for study 2 are patients registered in IBD BOOST study and those for study 3 are patients registered in IBD BioResource (but not in IBD Boost study). Detailed online questionnaires will be administered to them. These studies are just one-day assessment.