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Dyspepsia clinical trials

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NCT ID: NCT04697186 Completed - Gastric Cancer Clinical Trials

Helicobacter Pylori Eradication With Berberine Plus Amoxicillin Triple Therapy Versus Bismuth-containing Quadruple Therapy

Start date: January 7, 2021
Phase: Phase 4
Study type: Interventional

This study aims at evaluating efficacy and safety of berberine hydrochloride, amoxicillin and rabeprazole triple therapy versus bismuth-containing quadruple therapy(amoxicillin, clarithromycin, rabeprazole and bismuth) in the first eradication treatment of H. pylori. It is hypothesized that berberinehydrochloride, amoxicillin and rabeprazole triple therapy is non-inferior to bismuth-containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. 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.

NCT ID: NCT04684199 Completed - Dyspepsia Clinical Trials

Melatonin in Pediatric FD Population

Start date: August 2014
Phase: N/A
Study type: Interventional

There are two specific aims in this study. Specific Aim 1: Determine if melatonin results in a higher grade of clinical response than does placebo in children with functional dyspepsia (FD). Hypothesis: treatment of FD with melatonin will result in a higher grade of clinical response than will treatment with a placebo. Specific Aim 2: Evaluate the relationship between changes in sleep and improvement in pain in pediatric patients with functional dyspepsia receiving melatonin. Hypothesis: There will be no association between improvement in pain and improvement in sleep in children with functional dyspepsia receiving melatonin.

NCT ID: NCT04678492 Completed - Gastric Cancer Clinical Trials

Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Start date: December 20, 2020
Phase: Phase 4
Study type: Interventional

This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth,esomeprazole,tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior 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.

NCT ID: NCT04656730 Completed - Clinical trials for Irritable Bowel Syndrome

Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas

Start date: September 3, 2020
Phase: Phase 4
Study type: Interventional

Study to asess the effects of Iberogast® (STW5) and Iberogast® N (STW5-II) in intestinal gas transit and abdominal symptoms of patients suffering from irritable bowel syndrome or functional dyspepsia.

NCT ID: NCT04647955 Completed - Clinical trials for Functional Dyspepsia

Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup

Start date: February 22, 2013
Phase: Phase 4
Study type: Interventional

Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the gastroduodenum, in the absence of any structural or metabolic disease that is likely to explain these symptoms. To facilitate its diagnostic and therapeutic approach, the Rome consensus proposed to distinguish 2 subgroups: postprandial distress syndrome (PDS), is characterized by meal-related symptoms such as early satiation and postprandial fullness. At present, no validated instrument is available for the assessment of the symptom responsiveness in patients suffering from PDS. To develop a new PRO questionnaire, we have previously conducted focus group sessions and cognitive interviews in PDS patients to identify all relevant symptom items that characterize PDS. In this study we aim to validate the provisional Leuven Postprandial Distress Scale (LPDS) through the assessment of its consistency, reliability and ability to detect change in the framework of a controlled treatment trial.

NCT ID: NCT04525664 Completed - Clinical trials for Helicobacter Pylori Infection

Assessment and Management of Chronic Dyspepsia in Eastern Uganda

Start date: October 1, 2018
Phase: Early Phase 1
Study type: Interventional

Chronic dyspepsia, or a sensation of indigestion, remains an underdiagnosed and often inappropriately managed cause of morbidity in countries with limited medical resources. A recent questionnaire of Eastern Ugandan residents identified chronic dyspepsia as the most bothersome symptom in nearly 60% of respondents, resulting in significant morbidity and work days missed. One of the most common causes for chronic dyspepsia worldwide is infection with the stomach-adapted bacterium Helicobacter pylori (Hp), the most significant risk factor for the development of stomach cancer. In developing countries, particularly in sub-Saharan Africa, the prevalence of Hp has not been accurately determined, often owing to a lack of adequate diagnostic methods. More importantly, proper diagnosis and treatment of chronic dyspepsia would limit morbidity and mortality and help decrease the likelihood of progressing to stomach cancer. The purposes of this study are to identify the prevalence of chronic dyspepsia among residents of eastern Uganda using a questionnaire, to assess how common Hp infection is using fecal Hp antigen test kits, and to evaluate the efficacy of Hp eradication using standard Ugandan treatment guidelines. Participants who test positive for Hp infection by fecal Hp antigen testing will be offered Hp eradication treatment in the form of two antibiotics (clarithromycin, amoxicillin) and an acid-suppression medication (omeprazole), according to the current Ugandan guidelines. Patients with chronic dyspepsia who are negative for Hp (by fecal antigen testing) will be given a one-month trial of omeprazole alone, according to current American College of Gastroenterology guidelines, and their symptoms will be reassessed. At the end of the treatment regimens, participants will have the option to complete a follow-up questionnaire and provide stool samples for fecal antigen testing (if they were Hp-positive).

NCT ID: NCT04473079 Completed - Clinical trials for Helicobacter Pylori Infection

Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia

Start date: October 16, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Treatment for H. pylori eradication includes antibiotics. The treatment has decreased its efficiency (lower capability to eradicate the infection) due to increasing antibiotic resistance in the population. But the addition of probiotics to the treatment has been observed to increase efficiency, and decreasing the antibiotics' side effects. We set to evaluate whether Lacidofil® STRONG improves efficacy when added to the standard therapy to eradicate H. pylori.

NCT ID: NCT04464369 Completed - Clinical trials for Functional Dyspepsia

Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial

Start date: September 2013
Phase: Phase 4
Study type: Interventional

No instrument is available for the assessment of the symptoms in patients suffering from functional dyspepsia - postprandial distress syndrome patients - PDS. Indeed PDS is an unmet clinical need in drug development. To do so, the development of suitable endpoints for its efficacy evaluation is indicated. After interviews of patients suffering from PDS (Focus groups) and identification of the emerging symptoms a draft version of the Leuven Postprandial Distress Scale (LPDS) questionnaire has been designed. This study will assess the reliability of the scoring rule, the construct validity and ability to detect change of the draft LPDS. A minimum of 100 PDS patients will be randomised in two arms receiving respectively either Itopride 100 mg tid or Placebo tid during 8 weeks. Patients of both arms will be tested with LPDS using daily diary cards and by anchor questionnaires (PAGI-SYM, OSS, OTE) at baseline and during the study drug administration period.

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: 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.