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 massages 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 Crohns 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 Crohns disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PETCT 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 Crohns disease. During the study, participants will complete the PETCT 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 Crohns 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 Crohns 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.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

Researchers are studying TAK-279, an oral medicine aimed at reducing inflammation in adults with moderately to severely active Ulcerative Colitis UC or Crohns 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 observational study focuses on children under 18 years with inflammatory bowel diseases IBD, specifically Crohns disease CD and ulcerative colitis UC. The research aims to determine how many children develop these conditions each year, how the diseases affect different age groups, and how treatments vary over time as children grow. It also evaluates healthcare service use and associated costs for these patients. Data will be collected from a health insurance database without affecting routine care. The study includes children newly or previously diagnosed with CD or UC. Only data recorded during regular medical practice will be used to analyze disease incidence, treatment patterns, healthcare utilization, and costs over multiple years. Participants medical records will be reviewed for diagnosis codes, medication prescriptions, hospital visits, surgeries, and costs related to IBD. The study will assess annual incidence and prevalence rates, treatment changes, hospitalization frequency, emergency visits, and medical expenses. Data will be de-identified and analyzed for up to 13 years to understand long-term trends in pediatric IBD management.

This research aims to evaluate the safety of ALLO-ASC-CD, an intravenous infusion containing allogenic adipose-derived mesenchymal stem cells, in subjects with Crohns 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 Crohns 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 therapys effects.

Researchers are evaluating the long-term safety of subcutaneous guselkumab injections in children with moderately to severely active ulcerative colitis, Crohns disease, or juvenile psoriatic arthritis. This Phase 3 study focuses on pediatric participants who have previously been treated with guselkumab and will continue therapy in this extension study to monitor safety over an extended period. Participants who completed dosing in one of three primary pediatric guselkumab studies and are deemed by their investigator to benefit from continued treatment will join this long-term extension. Guselkumab is administered as a subcutaneous injection either every 8 weeks or every 4 weeks, depending on prior study assignment and clinical status. Some participants may switch dosing frequency once during the extension before unblinding, after which dosing aligns with their original regimen. Dose adjustments are restricted based on the primary study they came from. During the study, participants will receive guselkumab injections regularly and be monitored for treatment-emergent adverse events for up to nearly seven years. Researchers will assess safety outcomes through ongoing clinical evaluations over this time. Parents or legal representatives provide consent for children to participate, and children capable of understanding the study will give assent. The total participation duration may extend up to six years and nine months, allowing long-term safety data collection.

Researchers are studying the long-term safety of vedolizumab given as a subcutaneous injection to children and teenagers aged 2 to 17 years with moderate to severe active ulcerative colitis UC or Crohns disease CD. The study aims to understand medical problems that may arise from extended use of vedolizumab SC, as well as its impact on hospital visits due to bowel inflammation and on the quality of life for these young participants. This Phase 3b extension study follows participants from an earlier study VedolizumabSC-3003 who have responded well or not to treatment. Participants who responded well to vedolizumab SC in the parent study will continue treatment in this extension study, receiving the same dose and frequency. They will be randomly assigned to receive vedolizumab 108 mg either via a prefilled syringe with an autoinjector pen or with a needle safety device. Dosage is every two weeks for participants weighing at least 30 kg and every four weeks for those weighing between 10 and under 30 kg. Those who did not respond well or recently used corticosteroids will not receive vedolizumab in this study but will be observed in an observational cohort. Throughout the study, participants will visit their study clinic multiple times over up to two years. Researchers will monitor adverse events and serious adverse events up to 18 weeks after the last dose, as well as special safety events in the observational group. They will also assess time to major inflammatory bowel disease-related events and changes in quality of life using the IMPACT-III questionnaire at regular intervals. Participants will have a safety follow-up visit after treatment ends, and those in the observational group will be followed for about two years after their last dose in the parent study.