View clinical trials related to Gastroparesis.
Filter by:Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up. Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM. Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment. Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point.
The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are: - The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests. - The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria. - The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes. - The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients. Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.
This is a randomized controlled trial to explore the efficacy and safety of washed microbiota transplantation (WMT) for diabetic gastroparesis (DGP) patients.
Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) were first introduced as a therapeutic agent for type 2 diabetes mellitus but they are being increasingly used to target weight loss in obesity. One of the mechanisms by which weight loss is achieved, is increased satiety and significantly delayed gastric emptying. Tachyphylaxis for this effect has been reported with chronic use of long acting GLP-1-RA (e.g. semaglutide) but this was based on the paracetamol absorption technique or 13C breath test. Recent clinical data suggests semaglutide use does increase perioperative gastric content.This creates uncertainty for anaesthetists who are, anecdotally, more frequently faced with patients who may or may not have full stomachs despite adhering to conventional fasting guidelines. To address this issue the American Society of Anesthesiologists (ASA) has recently released guidelines in which it advises to hold GLP-1-RA for one day (if administered daily) or one week (if administered weekly). However, these recommendations are based on sparse empirical evidence and they do not necessarily follow from the known pharmacokinetic properties of these drugs. Typically, GLP-1-RA are administered in increasing doses over several weeks until a therapeutic steady state is achieved. Meanwhile the elimination half-life of e.g. semaglutide is 7 days. This means that holding semaglutide for one day or even one week might not be enough to attenuate its therapeutic effect of delayed gastric emptying. On the other hand if semaglutide were to be held for e.g. 5 terminal half-lifes, this would mean an unpractical 5 weeks during which glycemic control may be worsened and after which semaglutide doses would have to be incrementally increased again. Besides, hyperglycaemia secondary to semaglutide cessation can also delay gastric emptying. Further confounding the assessment of these patients there can be 'background' delayed gastric emptying in diabetic patients and more pronounced delayed gastric emptying in patients recently started on GLP-1-RA. The presence of gastro-intestinal symptoms (nausea, vomiting, dyspepsia, abdominal distension) might offer clinical information regarding increased gastric residue in this population. Gastric ultrasound is a point-of-care clinical and research tool that has steadily gained popularity to assess gastric content in patients not compliant with fasting rules or with certain comorbidities. Clinical decisions can be made based on the visualised content (e.g. solids, fluids or nothing) or through calculation of gastric volume by measuring antral circumference. In this study the investigators will examine gastric contents in patients who are taking semaglutide and in patients who are not. The investigators will then evaluate whether there is a difference in the incidence of full stomachs and whether gastric ultrasound influenced the anaesthetic plan of the treating anaesthetist.
Upper gastrointestinal tract disorders, such as gastroparesis, are common in critically ill patients in the ICU, estimated at 60%. Gastroparesis symptoms include nausea, vomiting and abdominal pain. Risk factors for the development of gastroparesis include diabetes, surgical injury to the vagus nerve (such as certain types of bariatric surgery, and in the past - surgeries for patients who suffered from peptic ulcer), use of drugs that inhibit the activity of the digestive system such as opiates, anticholinergic drugs, sepsis, as well as being bedridden and inactive - are all common conditions in critically ill patients. There are different definitions for gastroparesis. One of the accepted definitions refers to gastric residual volume (GRV) over 200 ml at one measurement. Gastroparesis is found in some studies to be associated with increased morbidity and mortality in critically ill patients. As mentioned above, it is known that sepsis is a risk factor for gastroparesis. According to our experience based on treatment of a large number of septic patients, we have the impression that often gastroparesis is an early sign for the development of sepsis. We did not find any studies that tested this hypothesis. In this study we would like to investigate whether the development of gastroparesis in critical patients in intensive care can be a predictive sign for the development of sepsis.
Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis. This will be a randomized controlled trial of all the patients who are referred to the University of Arkansas Medical Sciences (UAMS) for gastric peroral endoscopic pyloromyotomy (G-POEM) for treatment of refractory and severe gastroparesis. During G-POEM procedure, either single or double pyloromyotomy will be performed with randomization. The aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.
This is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. Several, mainly European, centres which perform G-POEM on a routine basis will be asked to participate. The main reason to assess the effectiveness of G-POEM in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of G-POEM. The participating centres will be asked to report appropriate patients among those who have undergone G-POEM since 2015 till December 2023. Patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after G-POEM. The main outcome is the symptomatic response at 6, 12 and 24 months (measured by GCSI score). Other endpoints will be change in other symptoms not covered by GCSI, change in gastric emptying rate and safety of the procedure. For each enrolled patient a case report form (CRF) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. The leading centre will be responsible for data collection and analysis.
This is a comprehensive pathophysiological study assessing various gastric functions in patients with diabetes mellitus. The investigators aim to examine the stomach with various measurement devices to gain information about its different functions and malfunctions. After the initial measurements, the examinations will be repeated after a year in each patient. Changes in the measurement values will be examined and their relations to each other and to the overall health of the patients will be investigated. For example it is hypothesised that diabetic patients also suffering from functional dyspepsia or gastroparesis will also show some changes in the function of the pyloric muscle.
A pilot study to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) between patients with diabetes and gastroparesis and those with diabetes without gastroparesis.