Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 152 trials
NCT06241183
The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.
NCT07008235
The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are: Does drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only. Participants will: Take drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.
NCT07537634
The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia. The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen. Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication. Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days. Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication. Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up. Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.
NCT03176927
There is a tremendous clinical need for a noninvasive technique that can assess gastric electrical activity and would be repeatable without any exposure to radiation. Investigators developed a new technique allowing to use noninvasive methods to assess bioelectrical activity in the gastrointestinal system. This has enabled to characterize the normal and pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG) records. Primary hypothesis for this proposal is that analysis of gastric slow wave uncoupling and propagation in multichannel MGG discriminates between normal and pathological gastric electrical activity. Eventually, investigators envision this research leading to new insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and chronic idiopathic nausea that would inform clinical management of these debilitating diseases.
NCT07539051
This prospective cohort study will evaluate the influence of psychoemotional status on the clinical course and quality of life of adult patients with functional dyspepsia and/or irritable bowel syndrome diagnosed according to Rome IV criteria. The study aims to assess the contribution of affective and somatoform disorders to quality of life and symptom burden in these patients. In participants with functional dyspepsia, the association of Helicobacter pylori status with psychoemotional status and quality of life will also be evaluated. Patients will complete validated questionnaires assessing quality of life, depression, anxiety, and somatization at baseline and again during follow-up after treatment. Clinical symptoms, pain severity, stool characteristics, and H. pylori status will also be assessed as applicable.
NCT06217393
The study is conducted in patients with functional dyspepsia or chronic gastritis. The purpose of this study is to: * assess whether the dose of Itopride Hydrochloride 150 mg extended release tablets, taken once daily has a similar effect on gastrointestinal symptoms caused by gastric dysmotility and delayed gastric emptying, like bloating sensation, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting in functional (non-ulcer) dyspepsia or chronic gastritis, as Itopride Hydrochloride 50 mg film coated tablets administered thrice a day. * investigate assessment of the treatment provided to each participant. * monitor safety and tolerability of Itopride Hydrochloride 150 mg extended release tablets, taken once daily before one of the main meals (preferably same meal throughout the treatment) and Itopride Hydrochloride 50 mg film coated tablets thrice daily before meals.
NCT07458490
This observational study aims to evaluate whether combining a simple blood test (H. pylori serology) with a non-invasive abdominal ultrasound can accurately predict severe complications in patients with peptic ulcer disease (PUD). Peptic ulcer complications, such as stomach bleeding or perforation, are serious and typically require an invasive procedure called an upper endoscopy for diagnosis and treatment. Researchers want to find out if these two non-invasive tests can be used together to create a reliable risk-scoring system. This system would help doctors quickly identify which patients are at a high risk for complications and need an urgent endoscopy, compared to those who are at a lower risk and can be safely monitored without the invasive procedure. The study will include adult patients presenting with stomach symptoms (like pain, nausea, or heartburn), as well as those with suspected or confirmed peptic ulcer disease. Participants will provide a blood sample to check for H. pylori antibodies and undergo a standard, painless abdominal ultrasound to examine the thickness of their stomach wall. An upper gastrointestinal endoscopy will be performed if it is clinically necessary as part of the patient's standard medical care.
NCT07449689
This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning. The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms. Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily. Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day. The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach. Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.
NCT07442734
Functional dyspepsia (FD) is a chronic disorder of gut-brain interaction characterized by bothersome upper abdominal symptoms arising from the gastroduodenal region. Diagnosis is made after clinical evaluation has excluded structural disease that could explain symptoms (e.g., upper gastrointestinal endoscopy). According to Rome IV criteria, FD is categorized into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), with symptom overlap commonly observed. FD is prevalent worldwide and is associated with substantial impairment in health-related quality of life and a significant socioeconomic burden. Sleep disturbance, anxiety, and depression are frequent in FD and are associated with symptom severity and recurrence. Current management-such as prokinetic agents, acid-suppressive therapy, and psychotropic medications when indicated-can be limited by variable efficacy, adverse effects, and concerns regarding long-term use. The pathophysiology of FD is multifactorial and incompletely understood; increasing evidence highlights dysregulation of the brain-gut axis and autonomic nervous system function (12,13). Auricular vagus nerve-related stimulation may influence brainstem neurotransmission, gastric tone/motility, and mood (14), suggesting a potentially safe, non-pharmacological approach for FD with comorbid sleep problems. However, the mechanistic links among autonomic regulation, gut microbiota/short-chain fatty acids, and FD remain uncertain. This study aims to evaluate the clinical efficacy and safety of auricular acupoint stimulation in FD patients with sleep disorders and to explore underlying mechanisms using brain-function assessments together with autonomic and gastrointestinal-related measures.
NCT05880199
The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.
NCT05655819
The purpose of this research is to collect data from patients diagnosed with functional dyspepsia who are treated with glutamine and describe safety and treatment results compared to patients taking a placebo. Glutamine, an essential amino acid in humans, is an important energy source for cells lining the gastrointestinal tract and has been shown to play an important role in regulating the strength of the intestinal wall.
NCT07010744
The Goal of this this clinical trial is to assess and compare the eradication rate of triple and quadruple therapy during treating helicobacter pylori infection among patients presented with dyspepsia. It will also assess the patient reported adverse events among two groups. H pylori infection will be confirmed by CLO (RUT) test and stool antigen test both. Standard triple therapy will be based on Esomeprazole 20 mg BD, Clarithromycin 500mg BD and Amoxicillin 1gm BD. Bismuth Quadruple therapy consists of Bismuth subsalicylate 300mg QDS, Tetracycline 500mg QDS and Metronidazole 400mg TDS. Patient will be confirmed H pylori eradication 4 weeks after completion of treatment by Stool antigen test only.
NCT07212907
Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause. It significantly impairs quality of life and has limited therapeutic options, as conventional treatments such as proton pump inhibitors often show modest efficacy and may cause side effects with long-term use. The gut and duodenal microbiota may play a role in FD. Spore-forming probiotics such as Bacillus coagulans MY01 and Bacillus subtilis MY02 have shown beneficial effects on FD symptoms in a randomized controlled trial. Ginger (Zingiber officinale) has a long history of traditional use as a gastroprotective agent and is supported by clinical and non-clinical data for improving gastric motility and related symptoms. This study (SUBTILE, STO-253) is a prospective, interventional, multicenter trial conducted in France. It will evaluate the effect of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) on FD symptoms and quality of life. A total of 198 adult patients diagnosed with FD according to Rome IV criteria and with a normal upper endoscopy will be recruited in primary care and gastroenterology practices. Participants will take one capsule of the study product daily for 8 weeks. The primary outcome is the change in the Patient Assessment of Gastrointestinal Symptom Severity (PAGI-SYM) total score between baseline and Week 8. Secondary outcomes include changes in quality of life (PAGI-QoL), treatment adherence, use of concomitant medications, evolution of lower gastrointestinal symptoms, patient and physician global impressions of change (PGI-C, CGI-I), and satisfaction (Likert scales). An exploratory objective will assess psychological impact using the Hospital Anxiety and Depression Scale (HADS). The study includes two site visits (baseline and end of study) and one telephone follow-up at Day 28. Safety and tolerability will be monitored through active reporting of adverse events. The trial aims to provide new evidence on the role of probiotics combined with ginger extract as a non-pharmacological strategy to improve digestive comfort and quality of life in patients with functional dyspepsia.
NCT07182890
Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria. Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor. The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.
NCT06760897
Single-center prospective interventional study aimed at demonstrating the effect of gastric-origin probiotics on dyspeptic symptoms, tryptophan metabolism, and microbiome parameters in FD patients without Helicobacter pylori infection, compared to a placebo group
NCT07261228
The goal of this observational study is to learn about the carbon footprint produced from diagnostic upper GI endoscopy in patients with dyspepsia and therapeutic upper GI endoscopy in patients with non-variceal upper GI bleeding. The main question it aims to answer is: • How much carbon footprint is generated from upper GI endoscopy Participants are already receiving diagnostic and therapeutic upper GI endoscopy as part of their regular medical care for dyspepsia and non-variceal upper GI bleeding, respectively. The carbon footprint generated from this treatment process is examined.
NCT07139366
This study aims at evaluating efficacy and safety of Saccharomyces boulardii combined with bismuth-containing quadruple Therapy versus bismuth-containing quadruple Therapy(bismuth#esomeprazole#tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that Saccharomyces boulardii combined with bismuth-containing quadruple Therapy is superior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
NCT07250308
Background: Dyspepsia is a common gastrointestinal complaint globally, affecting approximately 21.8% of the population. Among patients presenting with dyspeptic symptoms, over 80% are diagnosed with functional dyspepsia (FD), while approximately 16% are found to have chronic atrophic gastritis (CAG). CAG represents an important precancerous condition in the gastric cancer cascade, yet the relationship between pathologically confirmed CAG and dyspeptic symptoms remains poorly understood. The significant symptom overlap between CAG and FD creates diagnostic challenges in clinical practice. Study Objectives: The primary objective is to determine whether there are significant differences in the prevalence and severity of dyspeptic symptoms (including epigastric pain, burning sensation, early satiety, and postprandial fullness) between patients with pathologically confirmed CAG and those without CAG (non-CAG group) among individuals who present with endoscopic features suggestive of atrophic gastritis. Secondary objectives include: (1) analyzing the independent effects of various covariates (Helicobacter pylori infection, dietary habits, sleep quality, psychological factors) on dyspeptic symptoms; (2) developing a symptom-based predictive model for pathological CAG; and (3) conducting exploratory serum metabolomics analysis to identify potential biomarkers and metabolic pathways associated with FD symptoms. Study Design: This is a single-center, prospective, observational study conducted at the Third Affiliated Hospital of Zhejiang Chinese Medical University. The study will enroll approximately 258-315 adult patients (aged 18-75 years) who undergo endoscopy showing features suggestive of CAG within the past year. All participants will undergo standardized 5-point gastric mucosal biopsy according to the Updated Sydney System. Based on histopathological results, patients will be classified into pathological CAG group (presence of gastric mucosal atrophy) or non-CAG group (absence of atrophy). The study aims to recruit at least 80 pathologically confirmed non-CAG patients for comparison. Study Procedures: After obtaining informed consent, all enrolled patients will complete a comprehensive assessment at baseline including: demographic information, medical history, endoscopy and pathology results, Gastrointestinal Symptom Scale (GOSS) questionnaire using a 7-point Likert scale, H. pylori infection status (serology), dietary habits assessment, Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and perceived stress evaluation. A subset of participants will provide fasting blood samples for non-targeted metabolomics analysis using liquid chromatography-mass spectrometry (LC-MS) to identify metabolites related to amino acids, organic acids, lipids, and neurotransmitter precursors. This is a non-interventional study with all data and sample collection completed at enrollment without long-term follow-up. Primary Outcome: The primary outcome is the difference between pathological CAG and non-CAG groups in the prevalence and severity of dyspeptic symptoms, particularly cardinal FD symptoms (epigastric pain, burning, early satiety, postprandial fullness), assessed using the GOSS scale. A symptom score ≥4 on any cardinal symptom will define the presence of clinically significant FD symptoms. Expected Duration: The study is expected to last 24 months, including preparation, patient recruitment with data collection, and final statistical analysis and reporting phases. Significance: This study will provide evidence-based insights into the relationship between pathologically confirmed CAG and dyspeptic symptoms, potentially improving symptom management strategies and patient counseling. The metabolomics component may reveal novel biomarkers and pathways underlying symptom generation, laying groundwork for future mechanistic studies and personalized therapeutic approaches. Results will inform clinical practice and serve as preliminary data for larger-scale investigations.
NCT03869372
This is an exploratory neurophysiological study that will determine the impact of non-invasive brain stimulation on autonomic regulation, with a focus on gastrointestinal function. These studies should provide a basis for future brain-based neurotherapeutic strategies in patients with functional GI disorders.
NCT07210294
The aim of this study was to prove that press needle (PN) and medication are more effective in reducing symptoms and improving quality of life in people with functional dyspepsia compared to sham press needle (Sham PN) and medication. The main questions this study aims to answer are: * Does the press needle and medication group reduce symptoms in people with functional dyspepsia as assessed by the Short Form-Leeds Dyspepsia Questionnaire (SF-LDQ) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy? * Does the press-needle and medication group improve quality of life in people with functional dyspepsia as assessed by the Short-Form Nepean Dyspepsia Index (SF-NDI) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy? A total of 38 participants were randomly allocated into two groups, either PN or Sham PN needle groups Participants will: * Receive PN or Sham PN for 14 days and replaced on day 7. * Complete the SF-LDQ and SF-NDI questionnaires before therapy, on day 7, and day 14.