Inflammatory Bowel Disease (IBD)

Researchers are evaluating how abdominal massage affects gastrointestinal functions in patients who are mechanically ventilated and receiving enteral nutrition in intensive care units. This study aims to assess abdominal massage's impact on bowel movement frequency, gastric residual volume, and abdominal distension. The trial is designed as a prospective, single-blind randomized controlled trial to provide scientific evidence for abdominal massage use in this patient group. Participants are randomly assigned to either an intervention group receiving abdominal massage or a control group receiving standard care without massage. Abdominal massage is performed twice daily for 15 minutes over three days using specific techniques like effleurage, petrissage, and vibration. The massage is given at the bedside in a semi-Fowler position before enteral feeding, with routine nursing care provided to all patients. Throughout the study, researchers monitor bowel movements, gastric residual volume, abdominal distension, and stool consistency using specialized forms and scales twice daily. Data collection includes clinical assessments such as Glasgow Coma Scale and APACHE II scoring. The study lasts three days for each patient, with detailed recording of gastrointestinal function parameters to evaluate the effects of abdominal massage compared to standard care.

Researchers are studying whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. This early phase 1 case-control study aims to understand if early or developing fibrosis areas take up the tracer, which binds to fibroblast activation protein (FAP). Participants with small bowel Crohn's disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PET/CT scan using the radioactive tracer Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46), administered intravenously at a dose of 5 mCi ±10%. Cases include participants with small bowel strictures or probable strictures, while controls include those without strictures but may have other disease features. This design allows researchers to investigate different stages of fibrosis development in Crohn's disease. During the study, participants will complete the PET/CT scan with 68Ga-FAPI-46. Researchers will monitor the completion rates of these scans over an average of 2 years. Participants will be evaluated through imaging and clinical assessments related to their Crohn's disease status. Safety, tracer uptake patterns, and disease characteristics will be documented throughout the study period.

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors (TCRs) to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohn's disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are evaluating the safety of SPH7854 in healthy adults aged 18 to 45 years. This early phase 1 clinical trial aims to understand how well SPH7854 is tolerated and its effects on the body, focusing on inflammatory bowel disease. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and includes a randomized, double-blind design to compare SPH7854 with a placebo. Participants will receive SPH7854 granules orally at doses ranging from 50 to 3200 mg or a placebo. The study involves single and multiple dose escalations as well as an assessment of how food affects the drug. Both the experimental drug and placebo are given by mouth, and the trial includes several treatment groups to evaluate different dosing levels and conditions. During the approximately two-year study period, researchers will monitor participants for treatment-emergent adverse events and serious adverse events to assess safety. They will also measure pharmacokinetic parameters such as Tmax, Cmax, and AUC to understand how the drug is absorbed and processed in the body. Healthy volunteers will undergo medical exams and provide informed consent, with close monitoring throughout the trial to ensure safety and adherence.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are studying TAK-279, an oral medicine aimed at reducing inflammation in adults with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD), both serious long-term inflammatory bowel diseases. This study is an extension of previous parent studies and focuses on the long-term safety and tolerability of TAK-279, as well as its effects on reducing bowel inflammation and symptoms over time. Participants who responded to TAK-279 in the parent studies and completed specified treatment periods are invited to continue treatment in this open-label extension trial. All participants will receive Zasocitinib (TAK-279) capsules orally for up to 156 weeks (about 3 years). This includes those from different parent studies who completed either 12 or 52 weeks of treatment. During the study, participants will visit the clinic around 15 times. Researchers will monitor safety by tracking adverse events, vital signs, lab results, and heart function. They will also evaluate symptom improvements and quality of life using detailed clinical scores and questionnaires. The study aims to understand long-term effects and maintain careful follow-up through regular assessments over the treatment period.

This research aims to understand inflammatory bowel diseases (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC), in children under 18 years old in Korea. It focuses on the number of children diagnosed each year, how this varies by age group, their treatment over time, and the use and cost of healthcare services related to these conditions. CD and UC cause long-term inflammation and ulcers in the intestines. Participants include children who have been newly or previously diagnosed with CD or UC. The study analyzes data from health insurance records to examine epidemiology, demographics, clinical features, healthcare use, and treatment patterns. Only newly diagnosed children will be included for detailed treatment pattern and incidence analysis. All data is de-identified and collected from routine clinical practice records. Children's data will be reviewed for diagnosis codes, medication use, hospital visits, surgeries, and medical costs over several years. Researchers will measure annual incidence and prevalence rates, treatment sequences, hospitalizations, emergency visits, surgeries, and healthcare costs from 2012 to 2023, with follow-up up to 13 years. This observational study uses existing data without direct intervention or additional procedures.

This research aims to evaluate the safety of ALLO-ASC-CD, an intravenous infusion containing allogenic adipose-derived mesenchymal stem cells, in subjects with Crohn's disease who participated in a previous phase 1 clinical trial (ALLO-ASC-CD-101). These stem cells target injured tissue and help reduce inflammation, which may be important for treating immune-related diseases like Crohn's disease. This open-label follow-up study will monitor participants for 36 months to assess safety. The study involves only those subjects who received ALLO-ASC-CD injections during the earlier phase 1 trial. There is no new intervention in this follow-up phase; it serves to observe the long-term safety of the stem cell treatment previously given. The infusion studied contains cells aimed at modulating the immune response and aiding tissue repair. Participants will be observed over 36 months with regular monitoring to record any adverse events as a measure of safety and tolerability. The study includes assessments to ensure compliance and informed consent. Researchers will track safety outcomes without additional treatments or procedures, allowing thorough long-term evaluation of the original therapy's effects.

Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This study includes pediatric participants who have previously received guselkumab in primary studies and aims to monitor adverse events over an extended period. Participants who completed one of three primary pediatric guselkumab studies may join this long-term extension study if the investigator believes they will benefit from continued therapy. Guselkumab is given as a subcutaneous injection every 8 or 4 weeks, depending on the dosing regimen from the original study. Some participants have an option to adjust dosing frequency once during the extension, while others continue with their original schedule without changes. During the study, participants will have regular safety assessments focusing on treatment-emergent adverse events for up to nearly 7 years. Consent from parents or legal representatives and assent from children able to understand the study are required. Researchers will monitor participants closely, collecting data on safety and tolerability while allowing continued access to guselkumab throughout the extension period.

Researchers are evaluating the long-term safety of vedolizumab given as a subcutaneous injection to children and teenagers with moderate to severe active ulcerative colitis (UC) or Crohn's disease (CD). This study aims to understand medical problems that may occur with extended use, how long it takes before hospital visits due to bowel inflammation are needed, and the impact on quality of life. It includes participants who responded well to vedolizumab in a previous study and those who did not respond or used corticosteroids recently will be observed without further treatment. The study has two groups: a treatment cohort and an observational cohort. Participants in the treatment group will continue receiving vedolizumab subcutaneously at doses of 108 mg either via a prefilled syringe with an autoinjector pen or with a needle safety device. The dosing frequency depends on body weight: every two weeks for those weighing 30 kg or more, and every four weeks for those between 10 and less than 30 kg. The study treatment can last up to about 2 years or until the drug becomes commercially available for their condition. Those not eligible for treatment will be followed in the observational group for up to 2 years without receiving the drug. Participants will visit the study clinic multiple times for evaluations including monitoring for adverse events, assessing quality of life with the IMPACT-III questionnaire, and tracking time to major disease-related events. Safety follow-up visits will occur 18 weeks after the last dose for those in the treatment group. The study includes up to 70 pediatric participants aged 2 to 17 years and involves regular assessments to measure safety and treatment effects over time.