View clinical trials related to Heartburn.
Filter by:Remote un-controlled trial to evaluate the tolerability of MHS-1031 and separately the tolerability of the formulated placebo in subjects with heartburn. Candidates will have heartburn and be taking daily PPIs at up to twice the standard OTC or prescription dosage. Approximately 400 subjects (men and women of all races and ethnicities) will be randomly enrolled in a 1:1 ratio to receive Product or Placebo (1.4 ml) per day.
Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). The INDICA+PRO Impact Study, evaluated the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system. Thus, the following objectives were defined for the INDICA+PRO implementation study. The primary objective is to implement a standardised MAS in usual practice in community pharmacy in Spain. The secondary objectives include an evaluation of the clinical and economic outcomes and the role and impact of two different models of change agents. A pragmatic study with an effectiveness-implementation hybrid design type 3 will be undertaken using the Framework for the Implementation of Services in Pharmacy (FISpH). The study will be carried between October 2020 and December 2022. Two type of practice change facilitators FaFa and SEFaFa. Their main function, using the Observe-Plan-Do-Study-Act process, will be to facilitate the implementation through individualised continuous support to providers of the MAS. The depth and breadth of support to pharmacist providers by each type of change agents will vary. Pharmaceutical Associations (PA) and/or Spanish Society of Community Pharmacy (SEFAC) will invite community pharmacies/pharmacists. Participating pharmacists will need to sign a commitment form. The second study population will consist of patients presenting with minor ailments or requesting a non-prescription medication. Recruitment of patients will be carried out by the pharmacist providers. The inclusion criteria will be: patients or caregivers (aged ≥18 years, or younger if they are accompanied by an adult) presenting with 31 minor ailments, grouped into five categories (respiratory, moderate pain, digestive, dermatological and other) with pre-agreed referral protocols. Other symptoms may be included at the discretion of the pharmacists. The exclusion criteria will be patients who do not provide informed consent. The patient/pharmacist intervention will consist of a MAS protocol adapted for each symptom. The consultation will be record in an electronic data capture system (SEFAC eXPERT®-) that provides a step-by-step approach with protocols and clinical information embedded. The FISpH model will be used to guide the implementation of MAS. Two types of change agents, FaFas and SeFaFas, previously trained for 18 hours, will be used to facilitate the implementation. During each of the stages (exploration, preparation, testing and operation, and initial sustainability), strategies will be used by FaFas and SeFaFas to moderate implementation factors. The impact of strategies will be evaluated. Data on pharmacy/pharmacist's provider performance and patient outcomes will be provided to pharmacist, change agents and PA and SEFAC. FaFas and SeFaFas will have a classification system for barriers and facilitators derived from the constructs in the Consolidated Framework for Implementation Research (CFIR). The classification system for implementation strategies consists of an adaptation of the facilitation activities listed by Dogherty et al. These will be documented in an electronic data capture system. FaFas will train their pharmacists (max. of 25 pharmacies) for 6 hours and subsequently provide at least monthly follow-up. The research team will provide ongoing feedback and support to the FaFas and SeFaFas through periodically, hold group meetings by video conference between the research group and all the FaFas and SeFaFas. The research group will provide formal reports on the implementation process and patient outcomes. Other forms of communication such as emails, telephone calls or WhatsApp messaging will also be available. Implementation and patient consultation process and outcome variables will be measured such as reach, fidelity and integration. Outcome service indicators will be clinical, economic and humanistic. A patient follow up will occur at a maximum of 10 days. Continuous variables will be reported using mean and standard deviation, or median and percentiles. Categorical variables will be reported using percentages. T Student's test or the ANOVA test or Kruskal-Wallis. χ2 test, Fisher's exact test or Yate's chi-squared will also be used. To determine the relationship between the dependent and the independent variables, logistic regression models will be performed including the variables with statistical significance in the bivariate model. The level of significance will be set at p <0.05. Machine learning and big data techniques are being considered for predictive modelling. The research team will only have access to de-identified data of pharmacists and patients. This study protocol has been approved by the Granada Research Ethics Committee on the 5th February 2020.
This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily [QD]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.
Bile reflux gastropathy is caused by the backward flow of duodenal fluid into the stomach. A retrospective cohort study was performed to declare if the therapeutic biliary interventions cause bile reflux gastropathy, and to estimate its prevalence and risk factors, and to evaluate the gastric mucosa endoscopic and histopathologic changes.
The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.
The purpose of this online research study is to determine whether or not a gradual caffeine reduction program developed at Johns Hopkins can help people reduce their caffeine use. The investigators will provide materials to help guide caffeine reduction and ask questions to track caffeine use over several weeks. The investigators will also assess how reducing caffeine may benefit common caffeine-related problems such as anxiety, sleep disturbances, and gastrointestinal distress. The study will also determine whether or not people like participating in this caffeine reduction program in an online format.
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
The primary hypothesis of the present study is that supplementation with the Upset Stomach Relief test product will reduce the severity of the symptoms of occasional indigestion and heartburn.
Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and typically manifests as a painful burning sensation in the upper abdomen or in the chest. Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may come with side effects. There is suggestive evidence of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and time to onset.