View clinical trials related to Gastrointestinal Diseases.
Filter by:It is hoped that different forms of the same medicine, called PVP001, PVP002, and PVP003, will help people with celiac disease. Both healthy adults and adults with celiac disease will take part in this study. There are many main aims of the study. - To check if participants have side effects from different forms of the study medicine. These forms are called PVP001 (liquid in a cup), PVP002 capsule, and PVP003 tablet. - To check how well PVP003 breaks down gluten. - To check how much PVP003 participants can take without getting side effects from it. The study is in 4 parts. At the start of each part of the study, the study doctor will check to determine who can take part at the first study visit. Different groups of participants will be in different parts of the study. In all parts of the study, some participants will take 1 of the 3 forms of study medicine. Others will take a placebo. In this study, a placebo will look like the form of study medicine but will not have any medicine in it. This means that a placebo can either look like PVP001 liquid in a cup, the PVP002 tablet, or the PVP003 tablet. In Part 1, different small groups of participants will take lower to higher doses of PVP001 or PVP002 or a placebo. This is to work out the best dose of study medicine to take in other parts of the study. After treatment, participants will regularly visit the clinic to check that they have no problems with their treatment, including any side effects from their treatment. In Part 2, different small groups will take different doses of PVP001 or PVP002 or a placebo, either with or without a meal that has different amounts of gluten in it. This is to check if PVP001 or PVP002 has broken down gluten in the body. Participants will visit the clinic after treatment to check how much gluten has been broken down in the body. In Part 3, different small groups will take different doses of PVP003 or a placebo, either with or without a meal that has gluten in it. This is to check if PVP003 has broken down gluten in the body. Participants will visit the clinic after treatment to check if more gluten has broken down in the body. In Part 4, different small groups will take PVP003 or placebo 3 times a day for 5 days. After treatment, participants will visit the clinic to check that they have no problems with their treatment, including any side effects from their treatment.
There is evidence for the use of a diet low in short chain fermentable carbohydrates (low FODMAP diet) in the management of functional gut symptoms, such as abdominal pain and bloating. However, the provision of advice on the low FODMAP diet can be challenging due to limited resources and the need for a dietitian with expertise in the low FODMAP diet. The aim of this study is to assess the feasibility in terms of recruitment and retention in planning a future trial. The purpose of the future trial will be to investigate the clinical and cost effectiveness, as well as the acceptability of different education methods of the low FODMAP diet for the treatment of IBS. To date, there are no studies on the implementation of the low FOMDAP diet using a mobile app or leaflets in the education of the low FODMAP diet. Therefore, a feasibility study design was chosen in order to obtain key data on recruitment and retention rates at each study group.
This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.
This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator (PENFS) in adolescents with functional nausea. A neurostimulator is applied to the outer ear and stimulates several nerves that are thought to be involved in transmission of nausea and vomiting signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
Recent studies have shown that FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) free diet is efficient in subjects with Irritable Bowel Syndrome (IBS). Patients with Inflammatory Bowel Diseases (IBD) and celiac disease (CD) can experience functional gastrointestinal symptoms not related to inflammation, but data about the use of low FODMAPs diet in these settings are still scarce. The aim of the present study was to evaluate the usefulness of a low FODMAPs diet in patients with IBS, non-active IBD and CD on strict gluten-free diet (GFD). A low FODMAPs diet could be a valid option to contrast abdominal symptoms in patients with IBS, non-active IBD and CD on GFD, thus improving the quality of life and the social relations.
Primary Aim: The present study is a retrospective analysis of prospectively collected clinical data. Anonymized data from patients collected during routine clinical care from 9 units in the United Kingdom who undertake upper gastrointestinal (UGI) cancer surgery and perform pre-operative cardiopulmonary exercise testing will be interrogated. Data will be pooled at a central location (University Hospitals Southampton) and used to investigate the relationship between selected cardiopulmonary exercise testing (CPET) variables, in-hospital post-operative and survival outcomes after major UGI cancer surgery. Rationale: Our primary aim is to establish a reliable relationship between post-operative survival (1 and 3 -year) and oxygen uptake (VO2) at peak exercise (VO2 Peak); a secondary aim is to explore the multivariable relationship between selected CPET variables especially VO2 at the estimated lactate threshold/anaerobic threshold (AT), together with other selected CPET derived variables, and other important prognostic variables with post-operative complications (morbidity and mortality) in an attempt to risk stratify patients before major UGI surgery. Trial Design: Multicentre observational Inclusion Criteria: We aim to include all patients aged >18 years considered eligible by the MDT for major curative UGI cancer surgery and undergoing an enhanced recovery programme after surgery. Patients undergoing neoadjuvant chemotherapy or chemoradiotherapies will also be included. Patients having a CPET and initially scheduled for curative surgery, but end up not having surgery due to disease progression or other clinical reasons will be included and analysed separately. Exclusion Criteria: Patients will be excluded if they are physically unable to perform a CPET on a cycle ergometer, patients having emergency surgery, patients lacking complete in-hospital morbidity or mortality data and patients undergoing preoperative exercise interventions. Primary Trial Endpoints: 3 year overall survival
Smectite is a natural silicate clay belonging to the dioctahedral smectite class and has the ability directly to absorb bacterial toxins, bacteria, viruses and bile salts. Diosmectite also has a protective effect against intestinal inflammation hence suppressing production of cytokines such as IL-8 and TNFα. Investigators suggested that all these pharmacological properties may be beneficial for the treatment of NAFLD. Based on preclinical data, in rats with MSG induced obesity supplementation of alive probiotics with smectite gel (Symbiter-Forte) due to his absorbent activity lead to significant reduction of chronic systemic inflammatory markers, lower total NAS (NAFLD activity score) score, with more pronounced reduction of lobular inflammation as compared to administration of probiotic alone. In respect to preclinical data, in this double-blind single center randomized clinical trial (RCT) the efficacy of alive probiotics supplementation with smectite gel (Symbiter-Forte) vs. placebo in type-2 diabetes patient with NAFLD detected on ultrasonography will be studied
Prevalence and impact of Functional Gastrointestinal Disorders (FGIDs) and Related Signs and Symptoms in Infants and Toddlers in Thailand
10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.