Gastrointestinal Disorder

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 studying a new cancer treatment called [212Pb]VMT-Alpha-NET for tumors that have somatostatin receptors (SSTRs) on their surface. These tumors include those found in the lungs, head and neck, digestive tract, kidneys, and adrenal glands. The study focuses on people with tumors that have spread and cannot be removed by surgery. The goal is to find the highest safe dose of this drug and evaluate its safety and effects on these cancers. The treatment involves giving [212Pb]VMT-Alpha-NET through a vein on the first day of each 8-week cycle, for a total of four cycles. Some participants will also receive a related imaging drug, [203Pb]VMT-Alpha-NET, a few days before the first two cycles to track where the drug travels in the body using scans. After each dose, participants will stay in the hospital for a few nights and have weekly blood tests during each cycle. Participants will have physical exams, blood and urine tests, heart function tests, and imaging scans before and during the study. Researchers will monitor safety, drug effects, and tumor response through scans, lab tests, and questionnaires. Follow-up visits will continue for up to six years after the last treatment to check on long-term outcomes and overall health.

Researchers are conducting a combined retrospective and prospective cohort study at Beijing Chest Hospital to identify risk factors linked to mortality in patients with intestinal tuberculosis. The study first analyzes data collected over 15 years (2011 to 2025) from patients diagnosed and followed at the hospital. Using statistical methods, the study aims to find factors like age, disease severity, other illnesses, and treatment adherence that may impact survival. The study includes two groups: a retrospective cohort of patients diagnosed between 2011 and 2025 whose historical medical records and follow-up data are reviewed, and a prospective cohort of newly diagnosed patients enrolled after 2026 who will be followed over time. Data collected include demographics, clinical symptoms, laboratory tests, treatment details, and mortality outcomes to verify and supplement the findings from the first phase. Participants will provide clinical information through medical records or ongoing follow-up visits, allowing researchers to monitor their health status and treatment responses. Outcome measures focus on all-cause mortality, tracked over 15 years for the retrospective group and for 3 years from enrollment for the prospective group. This research helps improve understanding of factors influencing survival and may guide better management strategies for intestinal tuberculosis patients.

This research aims to evaluate the safety, tolerability, and nutrient absorption of the RELiZORB enzyme cartridge in children aged 2 to 18 years with Short Bowel Syndrome (SBS) who depend on parenteral nutrition (PN). SBS causes inadequate intestinal absorption due to significant loss of small bowel, requiring intravenous nutrition to maintain hydration and nutrition but leading to complications such as liver failure. The study explores whether predigesting fats with RELiZORB can improve absorption and reduce reliance on PN. The RELiZORB device is an enzyme cartridge connected to enteral feeding tubes that mimics pancreatic lipase to digest fats before they enter the gut, aiming to improve fat absorption without the need for bile acid emulsification. Participants will receive tube feeding through the device daily for 90 days. The study monitors changes in PN calories over time, along with growth, fecal fat, plasma fatty acids, and nutrition intake. Participants will be assessed at multiple time points during the 90-day treatment to evaluate PN calorie reduction and nutritional status. Safety and tolerability will be monitored by recording adverse events. The study involves regular clinical visits, laboratory tests, and nutrition assessments to measure the effectiveness of RELiZORB in improving enteral nutrition absorption and supporting growth while reducing PN dependence.

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.

Digestive cancers, including colorectal cancer, are a major health concern worldwide, accounting for 30% of all cancers. This research aims to create a collection of blood samples from patients with metastatic digestive adenocarcinoma who are receiving first or second line treatments. The goal is to study blood biomarkers that could help tailor treatments by predicting and monitoring response in a minimally invasive way. Patients in the study will have blood samples collected before starting treatment and then approximately every two months during treatment until it ends. Alongside this biological collection, standardized clinical data will be recorded in a database. This approach focuses on blood rather than tumor tissue, allowing repeated sampling to better understand tumor dynamics and treatment effects. Participants will be involved throughout their treatment period with regular blood draws and clinical data collection. Researchers will measure clinical and biological risk factors related to metastatic digestive cancer over a study period of up to 54 months. This ongoing monitoring aims to support research projects that improve personalized patient management strategies. The study is sponsored by the Institut du Cancer de Montpellier - Val d'Aurelle.

Researchers are evaluating a new AI-assisted Mobile Capsule Gastroscopy (MCG) system designed to detect various gastric diseases, including gastric cancer and precancerous lesions, in elderly and high-risk individuals. Gastric diseases pose a significant health challenge worldwide, especially in China, where gastric cancer has high incidence and mortality rates. Early detection through screening is crucial, as prompt treatment can greatly improve survival rates. This study aims to assess the effectiveness and practicality of MCG in community health centers for these populations. The MCG system includes a disposable capsule and a wireless portable receiver, allowing participants to complete the examination independently by following video instructions on a smartphone app and adjusting their body position to guide the capsule. An AI algorithm monitors gastric coverage in real time, and the video is accessible on the smartphone and can be uploaded for remote diagnosis. This non-invasive and user-friendly system does not require expensive magnetic navigation, making it suitable for widespread use in community settings. The study is part of a public health screening program targeting 10,000 elderly and high-risk residents. Participants will provide demographic and medical history data, undergo laboratory tests and MCG examination, and may receive esophagogastroduodenoscopy (EGD) and biopsies if needed. Short-term follow-up will monitor capsule excretion and any adverse events up to 14 days after MCG, while long-term follow-up will continue annually for five years to track gastric disease incidence and survival. Researchers will evaluate detection rates, safety, examination quality, patient satisfaction, and cost-effectiveness of the MCG system to inform future gastric disease prevention strategies.