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Dyspepsia clinical trials

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NCT ID: NCT04449887 Recruiting - Clinical trials for Functional Dyspepsia

The Role of Intestinal Flora in the Pathogenesis of FD and the Intervention of Xiangsha Liujunzi

Start date: July 7, 2020
Phase: N/A
Study type: Interventional

Functional dyspepsia (FD) is a common digestive system disease in clinic. Although it has not reached the level of life-threatening, it seriously affects the quality of life of patients. The pathogenesis of FD mainly involves gastric motility disorder and visceral hypersensitivity. At present, there are gastric motility promoting drugs and gastric acid inhibiting drugs, but they can not achieve satisfactory therapeutic effect. Traditional Chinese medicine has a good clinical effect on FD, but the specific mechanism is not clear. With the gradual deepening of intestinal flora research, it provides a useful tool for elucidating the mechanism of action of traditional Chinese medicine compound. The role of intestinal flora in the pathogenesis of FD, especially in the pathogenesis of symptoms, has not been studied, and the mechanism of Spleen-strengthening and motility-promoting effects of Xiangsha Liujun has not been studied from the perspective of intestinal flora. In this study, 16S rRNA high-throughput sequencing technology was used to observe the difference of intestinal flora between FD patients and normal people, and then to observe the effect of Xiangsha Liujun on intestinal flora of FD patients. The aim of this study was to explore the role of intestinal flora in the pathogenesis of FD and to elucidate the therapeutic mechanism of Xiangsha Liujunzi by regulating intestinal flora of FD patients, so as to provide support for follow-up clinical and experimental studies.

NCT ID: NCT04449185 Not yet recruiting - Dyspepsia Clinical Trials

Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

Start date: June 30, 2020
Phase: Phase 4
Study type: Interventional

The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

NCT ID: NCT04429802 Completed - Dyspepsia Clinical Trials

The Effect of Prucalopride (Resolor®) on Gastric Motor Function and Gastric Sensitivity

Start date: September 26, 2013
Phase: N/A
Study type: Interventional

Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. Disturbances of gastric motor function have been implicated the pathogenesis of PDS symptoms, and hence, motility modifying agents are considered for the treatment of PDS. Prucalopride (Resolor®), a highly selective 5-TH4 receptor agonist which stimulates gastrointestinal motility throughout the GI tract, is currently approved for the treatment of chronic constipation. The objective of this study was to evaluate the effect of prucalopride on gastric sensorimotor function in healthy volunteers (HV). Methods A total of 17 HV (59% females, mean age 29.4±2.7 years) underwent a barostat and intragastric pressure (IGP) measurements after treatment with placebo or prucalopride (2 mg) in a single blinded cross-over fashion. Isobaric distentions with stepwise increments of 2 mm Hg starting from minimal distending pressure (MDP) and scoring of intensities of gastric sensations (0-6: pain) were used to determine gastric compliance and sensitivity. Gastric accommodation (GA) was quantified as the difference (delta) in intra-balloon volume 30 min before and 60 min after ingestion of 200 ml of a nutrient drink (ND) (1.5 kcal mL(-1)). GA measured by IGP was quantified as the drop of IGP from baseline during the intragastric infusion of ND until maximal satiation. During all tests, epigastric symptoms were scored every 5 minutes.

NCT ID: NCT04380233 Recruiting - Clinical trials for Functional Dyspepsia

Zhizhu Kuanzhong Capsule for Patients With Functional Dyspepsia-Postprandial Distress Syndrome

ZZKZ-FD
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

A 13 weeks randomized, double-blind and placebo parallel-controlled trial will be conducted to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treatment of functional dyspepsia-postprandial distress syndrome.

NCT ID: NCT04352062 Completed - Clinical trials for Melatonin Deficiency

Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia

Start date: January 9, 2011
Phase: N/A
Study type: Interventional

Background: The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, with consideration of Helicobacter infection. Methods: The study comprised 152 subjects Including 30 healthy women (group I), 60 women with asymptomatic H.pylori infection (group II), and 64 women H. pylori infected with chronic dyspepsia(group III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone, melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at bedtime, for six months.

NCT ID: NCT04350346 Recruiting - Gallstone Clinical Trials

The Comparative Analysis Between Motilitone and Gasmotin for the Symptom Relief in Gallstone Patients With Functional Dyspepsia

Start date: March 25, 2020
Phase: N/A
Study type: Interventional

- (Cause of cholelithiasis) Recently, the average age has increased, and the occurrence of gallstones has increased as the dietary life has been westernized due to the improvement of socio-economic level. When cholesterol increases, the occurrence of gallstones increases. Factors include high-calorie high-fat diet, increasing age, women, pregnant women, obesity, and oral contraceptives. There are cases. As another cause, gallstones occur well even when bile stasis occurs due to a decrease in motility of the gallbladder. These are conditions that lower mobility. And cholelithiasis has a genetic tendency in about 30%. In addition, since the eating habits of the family are similar, the genetic factors and the eating habits overlap, which often leads to the occurrence of cholelithiasis in the family. - (symptoms of cholelithiasis) In most cases, complaints of non-specific digestive system symptoms, such as abdominal bloating, nausea, and especially indigestion after fatty diet, are often observed. According to domestic reports, the nonspecific symptoms complained by patients with cholelithiasis were indigestion, flatulence, frequent belching, nausea, loss of appetite, diarrhea, and vomiting. In general, many healthy people without gallstones complain of non-specific digestive system symptoms in 50% of cases, and there is a possibility that functional gastrointestinal diseases such as dyspepsia, peptic ulcer, and gastritis may be accompanied by these digestive system symptoms. It is difficult to know whether it is unrelated to gallstones. Symptoms caused by typical cholelithiasis usually have a characteristic that they often improve on their own after a few hours, and the start and end of the symptoms are relatively clear and repeatedly occur. In addition, various symptoms are displayed depending on the presence or absence of inflammation and progression. - (Principle of treatment of cholelithiasis) 1. Medical treatment: Medical treatment of gallstones is a method of dissolving using drugs to treat cholesterol gallstones in gallbladder stones. In 1973, Nakano et al. [1] published the first example of dissolving cholesterol gallstones using ursodeoxycholic acid (UDCA). Currently, UDCA is the only drug administered to patients with asymptomatic or mild symptoms of cholelithiasis in actual clinical practice, and there is no specific prescription drug. 2. Surgical treatment: In the case of indications of cholecystectomy, acute cholecystitis, severe symptoms, chronic cholecystitis with severe thickening of the gallbladder wall, repeated and severe symptoms, porcelain gallbladder, Patients with gallstones of 3 cm or more in size, patients with anomalous pancreato-biliary duct unions, or gallbladder polyps. - (Study on increasing gallbladder contractility) So far, there have been studies that some drugs increase or decrease gallbladder contractility. Catnach SM et al. [2] reported that erythromycin increased gallbladder contractility in patients with autonomic neuropathy due to diabetes. Sengupta S et al. [3] reported that indoramin (α-adrenergic antagonist), a prokinetic agent, increased gallbladder contractility in patients with cholelithiasis, resulting in a significant decrease in gallbladder volume. Motilitone® developed in Korea is a gastrointestinal motility stimulator that stimulates 5-HT4 receptors to increase acetylcholine secretion and has a mechanism of contracting smooth muscles, improving symptoms in patients with functional dyspepsia in cholelithiasis It is expected to be able to give, and it is thought to have the effect of preventing the crystallization of bile acids due to an increase in the gallbladder contractility, thereby preventing the formation of gallstones and preventing newly generated gallstones. To date, there are no special drugs for dyspepsia or pain improvement in patients with cholelithiasis. It is hypothesized that administration of motilitone® will increase the contractile capacity of the gallbladder, thereby improving digestion and preventing further formation of gallstones. As a control group, Gasmotin® was administered to improve functional dyspepsia, and the degree of symptom improvement was measured and compared by completing the Symptom Score Questionnaire for Indigestion between the two groups.

NCT ID: NCT04302402 Not yet recruiting - Dyspepsia Clinical Trials

Multi-dimensional Clinical and Pathophysiological Profiles of Patients With Functional Dyspepsia and Effect of Gut Microbiota Manipulation Using Rifaximin for Its Treatment

Start date: March 2020
Phase: Phase 2
Study type: Interventional

Functional dyspepsia (FD) is a common condition associated with significant morbidity, healthcare expenditure, work absenteeism and productivity, and reduced quality of life. The prevalence of this condition is as high as 15% in the rural (Jaunpur district, Uttar Pradesh) and 30% of the urban (Mumbai) Indian population. Pathophysiologically, FD is an enigmatic condition that may be contributed by a variable combination of psychosocial issues like anxiety, depression, insomnia, and micro-organic issues like Helicobacter pylori infection, gastritis, duodenitis, hypersecretion of acid, degree of gastric atrophy, gastric microbiota dysbiosis. Accordingly, investigators want to study these factors among patients with FD. Rifaximin has been shown to be useful in the treatment of FD in a recent randomized controlled trial from Hong Kong. Since microbiota dysbiosis may be an important issue in FD, investigators want to treat them with rifaximin in a randomized placebo-controlled trial and repeat the parameters such as dyspepsia score, hospital Anxiety and Depression Scale (HADS) score, Pittsburgh Sleep Quality Index (PSQI). Investigators wish to study the pathogenetic mechanism of FD and evaluate baseline factors that may help to predict response to gut microbiota manipulation in these patients. Objectives: a. To study the patients with FD for gut microbiota including gastric H. pylori, gastric atrophy (by PG-1 PG-II ratio), hospital anxiety and depression score, and sleep disorders b. To see the effect of treatment of these patients with rifaximin vs. placebo in a randomized controlled trial not only for the improvement in symptoms but also for improvement in HADS score and sleep quality c. To study whether any pre-treatment factors including gut microbiota predict the response of symptoms to treatment with rifaximin.

NCT ID: NCT04294823 Withdrawn - GERD Clinical Trials

Sensitivity and Specificity of the Modified Helicobacter Test INFAI

Start date: November 2020
Phase:
Study type: Observational

Study to confirm the sensitivity of the C^13-UBT using the new test meal for H. Pylori in patients with dyspepsia and GERD taking PPI Secondary objectives : to compare the sensitivity and specificity of the C^13-UBT using the new test meal and standard test meal for H.Pylori in patients with dyspepsia and GERD taking PPI. to complete the results of the Helicbacter test INFAI using new test meal for H.Pylori in patients with dyspepsia and GERD taking PPI with : - Histology score for H.Pylori in antrum an corpus using the updated Sydney System - Sex, - Age, - Body Mass Index (BMI)

NCT ID: NCT04279990 Completed - Clinical trials for Functional Dyspepsia

Assessment of Gastric Motility on Funtional Dyspepsia and Joint Hypermobility Syndrome

Start date: July 4, 2014
Phase:
Study type: Observational

Functional dyspepsia (FD) is defined as the presence of gastroduodenal symptoms in the absence of organic disease that is likely to explain the symptoms. Joint hypermobility (JH) refers to the increased passive or active movement of a joint beyond its normal range. Recent reports have highlighted the co-existence of FD with Ehlers-Danlos syndrome type III or hypermobility type (EDSIII). The association between FD and EDS III, and the underlying pathophysiological alterations, are poorly understood. We hypothesised that EDS III might influence gastroduodenal sensorimotor function, resulting in dyspeptic symptoms. Therefore, the aim of this study is to explore the impact of EDS III on gastric motility, nutrient tolerance and dyspeptic symptoms in patients with functional dyspepsia.Our aim is to study the prevalence of EDSIII in FD compared to healthy subjects (HS) and to study the impact of co-existing EDSIII on gastric motility, nutrient tolerance and dyspeptic symptoms in FD.

NCT ID: NCT04247100 Terminated - Clinical trials for Irritable Bowel Syndrome

A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.