Colitis

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 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.

Researchers are investigating the relationship between gut microbiota dysfunction and Alzheimer's disease (AD), focusing on how gut-derived short-chain fatty acids (SCFAs) may influence brain function through the "gut microbiota-SCFAs-brain networks" pathway. This observational study will explore differences in SCFAs among people across the AD spectrum, including cognitively normal individuals, those with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and AD dementia. The project aims to clarify the interactions between gut microbiome, metabolites, and brain changes using high-throughput metabolomics and multi-modal MRI techniques. Participants will be grouped into four categories: cognitively normal, SCD, MCI, and AD dementia. The study involves collecting multi-omics data, including gut microbiome analysis, metabolomics, and neuroimaging, to establish a diagnostic model for SCD due to preclinical AD using machine learning methods. The study spans five years, during which gut microbiome changes, SCFAs levels, and multi-omics biomarkers related to cognitive impairment conversion will be monitored. Participants will undergo cognitive tests and brain imaging scans, along with gut microbiome and metabolite sample collection. Researchers will assess the interaction mechanisms of the gut microbiota-SCFAs-brain networks over five years. The study includes both healthy volunteers and patients aged 60 to 80. Outcome measures focus on changes in gut microbiome, SCFAs, and biomarkers linked to cognitive decline, with long-term follow-up to better understand the disease progression and its early detection.

Researchers are studying the drug duvakitug in a large, Phase 3 clinical trial to assess its effectiveness and safety for people with moderately to severely active Crohn's Disease. This randomized, double-blind, placebo-controlled study aims to evaluate whether duvakitug can help maintain remission and improve symptoms, with important outcome measures including clinical remission and endoscopic response at 40 weeks. Participants receive subcutaneous injections of duvakitug or a placebo according to the study protocol. The trial includes a 40-week pivotal maintenance phase followed by a 240-week open-label extension phase, allowing some participants to continue treatment. Those not entering the extension will have a 45-day follow-up visit. In total, participants may be involved for up to 286 weeks, with up to 43 on-site visits across both phases. During the study, participants undergo clinical evaluations, endoscopic assessments, and symptom monitoring at regular intervals. Researchers will measure clinical remission using CDAI and PRO-2 scores, endoscopic response using SES-CD, and other outcomes such as fatigue, quality of life, bowel urgency, and hospitalization rates. Safety is closely monitored through adverse event tracking and serum drug concentration measurements throughout treatment and follow-up periods.

Researchers are evaluating the efficacy and safety of duvakitug in people with moderately to severely active Ulcerative Colitis (UC) in a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study. The study is sponsored by Sanofi and aims to assess how well duvakitug maintains clinical remission and improves symptoms in participants who have responded to prior treatment. This investigation includes a long-term follow-up to understand the treatment's effects over several years. Participants receive subcutaneous injections of duvakitug or placebo according to protocol. The study includes a 40-week pivotal maintenance phase followed by a 240-week open-label extension (OLE) phase for those who continue treatment. Participants not entering the extension phase will have a 45-day follow-up after the maintenance period. The total treatment duration may be up to 280 weeks, with up to 32 on-site visits during the entire study. During the study, participants will undergo regular assessments including clinical remission measured by the modified Mayo Score, endoscopic and histologic evaluations, symptom tracking like bowel urgency and abdominal pain, and quality of life questionnaires. Safety will be monitored through adverse event reporting and serum drug concentration measurements. The primary outcome is the proportion of participants achieving clinical remission at week 40, and the study will also track long-term safety and efficacy outcomes through the extension phase.