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 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 studying tumors that have somatostatin receptors SSTRs on their surface, which include tumors in the lung, head and neck, digestive tract, kidneys, and adrenal glands. This trial tests a drug called 212PbVMT-Alpha-NET, which is designed to target these receptors and potentially help shrink tumors that have spread and cannot be removed surgically. The study focuses on people aged 18 and older with these specific types of tumors and aims to determine the maximum tolerated dose and safety of the drug. Participants receive 212PbVMT-Alpha-NET through a vein on the first day of four 8-week cycles. Some participants will also receive a related imaging drug, 203PbVMT-Alpha-NET, a few days before the first two treatment cycles to allow whole-body scans that track how the drug spreads in the body. After each infusion, participants stay in the hospital for a few nights and have weekly blood tests during each treatment cycle. The study includes dose escalation to find the best dose and then dose expansion at that dose level. Throughout the study, participants undergo physical exams, blood and urine tests, imaging scans including PETCT and SPECTCT, heart function tests, and may provide tumor tissue samples if needed. Follow-up visits occur about 30 days after treatment ends, then every 12 weeks for up to 3 years, with annual check-ins continuing up to 6 years after the last treatment. Researchers monitor safety, response to treatment, and survival outcomes during this time.

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.

Children with short bowel syndrome SBS have reduced intestinal length or function, causing poor absorption of nutrients and requiring intravenous nutrition parenteral nutrition, PN to sustain hydration and nutrition. Long-term PN use can lead to serious complications including liver failure. This study evaluates the RELiZORB enzyme cartridge, a device designed to improve fat digestion and absorption by predigesting fats in enteral feeding tubes, potentially reducing the need for PN in children aged 2 to 18 years who are PN dependent. Participants will use the RELiZORB device connected inline with their enteral feeding tubes daily for 90 days. The device mimics pancreatic lipase to digest fats before they enter the intestine, bypassing the need for bile acid emulsification. Tube feeds run across the device to enhance fat absorption. This open-label, single-group trial monitors changes in PN calories, growth, fecal fat, plasma fatty acids, and nutrition intake over the study period. During the study, participants will have assessments at multiple timepoints including days 7, 14, 28, 60, and 90. Researchers will measure effectiveness by changes in PN calorie requirements and weight, monitor safety by tracking adverse events, and evaluate tolerability. The study also involves tracking growth, stool fat content, blood fatty acid levels, and nutrition intake. The total participation duration is 90 days, with regular clinic visits for monitoring and data collection.

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 investigating the safety and effects of FT1 injections in adults with short bowel syndrome SBS, a condition caused by surgical removal of part of the small intestine. This phase 2 trial compares FT1 to a placebo to understand how well FT1 works and how it behaves in the body. The study uses a crossover design where participants receive both treatments separated by a washout period. Participants receive weekly subcutaneous injections of FT1 or placebo for 5 weeks, followed by at least a 6-week washout period, then switch to the other treatment for another 5 weeks. Each cycles effectiveness is assessed by a 72-hour metabolic balance study, measuring changes in fecal wet weight and other markers. The study is double-blind and randomized to ensure unbiased results. During the study, participants attend clinic visits for assessments including metabolic balance studies, blood tests measuring plasma concentrations and biomarkers, and monitoring for adverse events. Outcomes measured include treatment safety, changes in fecal and urine volumes, and plasma levels of L-citrulline. The total participation period spans approximately 5 months from the first dose to study completion, with close safety monitoring throughout.

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.

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 dAurelle.