Clinical Research Directory

Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD

The goal of this observational study is to learn whether signs of immune aging and frailty can help predict the balance of benefits and risks of advanced therapies in adults aged 60 years or older with inflammatory bowel disease (IBD) who are starting a new advanced therapy. Treatment will be chosen by the participant's usual clinical team and will not be assigned by the study. The main questions it aims to answer are: Are baseline immune-aging and frailty characteristics associated with net clinical benefit at 52 weeks, defined as steroid-free clinical remission without serious infection, treatment discontinuation because of adverse events, IBD-related hospitalization, or IBD-related surgery? Can a low-cost combination of clinical and laboratory markers help identify older adults with IBD who are more likely to have favorable or unfavorable outcomes after starting advanced therapy? Participants will: Continue the advanced therapy selected as part of their usual clinical care. Complete study assessments of frailty, nutritional status, disease activity, and other health factors. Have routine and study-related blood tests, including measures related to immune aging such as CD4/CD8 ratio and interleukin-6 (IL-6). Be followed at approximately baseline, weeks 6, 14, 26, and 52, with longer-term safety follow-up planned to week 104 when feasible. Have information collected on remission, infections, hospitalizations, surgery, treatment continuation or change, and other health outcomes.

Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)

The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD). The main questions it aims to answer are: Does modafinil reduce fatigue more effectively than placebo, as measured by the mean difference in section I of the IBD-F questionnaire at week 8? Is modafinil safe and well tolerated in patients with quiescent IBD and severe fatigue? Researchers will compare modafinil to placebo to see if modafinil improves fatigue outcomes. Participants will: attend one screening visit including assessment of disease activity, blood tests, stool testing, and an ECG; take modafinil or placebo for 8 weeks, starting at 100 mg daily with possible dose increases based on response and tolerability; complete online questionnaires at baseline, week 4, week 8, and week 12 about fatigue, quality of life, sleep, mood, and work productivity; be contacted regularly during the treatment period to discuss effect and side effects of the study medication; complete an online effort-based decision-making task at baseline and week 8.

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.

Narrow Band Imaging Versus Artificial Intelligence for Colonic Surveillance in Inflammatory Bowel Disease

Patients with inflammatory bowel disease (IBD) - ulcerative colitis or Crohn's disease - have a higher risk of developing colorectal cancer than the general population. For this reason, regular colonoscopies are recommended to look for early warning signs, such as abnormal areas of tissue called dysplasia, which can develop into cancer over time. Finding these abnormal areas during colonoscopy can be difficult because IBD causes ongoing inflammation that can make the bowel mucosa look irregular, hiding subtle changes. Doctors currently use a technique called narrow-band imaging (NBI), a special light setting on the colonoscope that enhances the visibility of the bowel, to help spot these areas more easily. A newer tool, artificial intelligence (AI)-assisted detection, has shown promise in helping doctors find more polyps during routine colonoscopies in the general population. However, this AI tool was developed and tested mostly in people without IBD, so it is not yet known whether it works as well in people with IBD, whose bowel can look very different due to chronic inflammation. This study will directly compare the AI tool (CADe; ENDO-AID, Olympus) with narrow-band imaging to see which one is better at finding abnormal areas during colonoscopy in patients with long-standing ulcerative colitis or Crohn's disease who are having their routine cancer surveillance exam. Each participant will have one colonoscopy in which the bowel is examined twice in a row, once with each technique, by two different doctors, in random order. This lets researchers compare both methods directly within the same patient, which is the fairest comparison. The study aims to enroll 60 patients at Vall d'Hebron University Hospital in Barcelona, Spain. Researchers hope the results will help determine whether AI tools - which are widely available and easier to use than NBI - can be a reliable alternative for IBD surveillance, potentially making this important cancer-screening exam more accessible in the future.

Eating Disorders in Patients With IBD

Inflammatory bowel diseases (IBD) may influence eating habits and lead some patients to adopt restrictive dietary behaviours to control gastrointestinal symptoms. In some cases, these behaviours may become maladaptive and resemble eating disorders, including avoidant/restrictive food intake disorder (ARFID). This observational cross-sectional study assesses the prevalence of eating disorder risk and ARFID risk among adult patients with IBD. Participants complete validated questionnaires evaluating eating behaviours, nutritional status, and IBD-related disability. Clinical and demographic data are also collected.

ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool

The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.

Study on the Use of Traditional Chinese Medicine Diagnostic Tools to Assist in Identifying the Clinical Characteristics of Inflammatory Bowel Disease and Research on Metabolic Plastids of Tongue Coating

This study will be conducted at the outpatient clinic of China Medical University hospital. It is expected to enroll two groups of 30 subjects, including the experimental group must meet the clinical diagnosis of IBD, and the control group without IBD and have no obvious gastrointestinal symptoms . This proje ct uses modern TCM diagnostic tools, such as tongue diagnosis instrument, auscul tation instrument, TCM constitution questionnaire, and pulse diagnosis instrument to establish the comparison of physiological and biochemical indicators such as TCM phenotype and laboratory tests data in patients with IBD. Besides, another purpose of this project is to analyze the tongue coating metabolites of patients with IBD by mass spectrometry, and to establish a research model of tongue coating an d metabolomics for patien ts with IBD and the prognosis analysis of acute and remission phases.

Prevalence of Helicobacter Pylori on Patients With Chronic Inflammatory Bowel Disease (IBD) at the CHU of Guadeloupe

Clinical and experimental data suggest that dysbiosis may play a pivotal role in the pathogenesis of intestinal bowel disease (IBD). However, to the best of our knowledge, the composition of gastric and of intestinal microbiome has never been investigated in a population with IBD according to the presence/absence of Helicobacter pylori (H. pylori) in the stomach.

Molecular Inflammation Board at the Center for Personalized Medicine

Molecular Inflammation Board at the Center for Personalized Medicine

Spiritual Needs of European Patients With Inflammatory Bowel Disease and Their Caregivers

A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) adopting the methodology \[3\] described in figure 1. To ensure they are both valid and user-friendly, the Thinking Out Loud (TOL) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. TOL involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. The second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated SPNQ-EV and IIQ developed in phase 1. The European study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. Eligible participants include adolescents and adults with IBD, as well as their caregivers, recruited via nurses and patient associations.