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Digestive System Diseases clinical trials

View clinical trials related to Digestive System Diseases.

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NCT ID: NCT03602677 Recruiting - Colorectal Cancer Clinical Trials

Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage

ICG-COLORAL
Start date: September 24, 2018
Phase: N/A
Study type: Interventional

This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.

NCT ID: NCT03594331 Terminated - Clinical trials for Digestive System Disease

Gastric Gluten-Degradation Activity of PvP001

Start date: May 25, 2018
Phase: Phase 1
Study type: Interventional

This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single meal. Within each gluten exposure group, increasing doses of PvP001 (or placebo) will be administered.

NCT ID: NCT03592069 Completed - H.Pylori Infection Clinical Trials

Concomitant Versus Hybrid Regimen for H. Pylori Eradication

Start date: February 21, 2018
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03588013 Completed - Clinical trials for Gastrointestinal Disease

Study of Environmental Enteropathy and Malnutrition in Pakistan

SEEM
Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Environmental Enteropathy (EE) is an acquired sub-clinical inflammatory gut condition in which alterations in intestinal structure, function, and local and systemic immune activation lead to impaired vaccine responses, decreased cognitive potential and undernutrition in low-middle income countries. Approximately half of all global deaths in children aged less than five years are attributable to undernutrition making the study of EE an area of critical priority. However, given the operational limitations and ethical considerations for safely obtaining intestinal biopsies from young children in low resource settings, there have been few detailed investigations of human intestinal tissue in this vulnerable patient group for whom reversal of EE would provide the greatest benefit. EE biomarkers have been studied in different settings but these have not been correlated with the gold standard histopathology confirmation. The Study of Environment Enteropathy and Malnutrition in Pakistan (SEEM Pakistan) is designed to better understand the pathophysiology, predictors, biomarkers, and potential management strategies of EE to inform strategies to eradicate this debilitating pathology.

NCT ID: NCT03566160 Active, not recruiting - Clinical trials for Gastrointestinal Disease

Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

Environmental enteric dysfunction (EED) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene. EED is a major driver of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection, affecting 25% of all children globally and causing over a million deaths each year. Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic. In order to prevent the deleterious and permanent sequelae of the disease, there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2. Currently, the only means for directly evaluating the intestine is endoscopy with mucosal biopsy. Unfortunately, endoscopy is untenable for the study of EED because of limited resources and the high cost. As a result, there is a clear, unmet need for a less invasive tool that can be used in low-and-middle-income-countries (LMICs) to evaluate the intestine in population with EED. This work is supported by a grant from The Bill and Melinda Gates Foundation (BMGF). The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions. Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information. The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults.

NCT ID: NCT03565263 Completed - Quality of Life Clinical Trials

Functional Gastrointestinal Disorders in Pediatric IBD

TFI-MICI
Start date: April 3, 2018
Phase:
Study type: Observational

Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with fatigue, anxiety and depression. There is very little data regarding pediatric specificities of these FGID. Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with IBD in remission. Secondary aims are to investigate a possible association of FGID with fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety and depression in the parents. Methods: This will be an observational, case-control study. All patients between 9 and 18 years old , with IBD in remission will be invited to participate. Questionnaires will be web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients with FGID will be compared to patients without FGID in terms of clinical characteristics, disease phenotype and associated psychological comorbidities.

NCT ID: NCT03559543 Completed - Clinical trials for Gastrointestinal Neoplasms

Evaluation of Ocoxin®-Viusid® in Metastatic Colorectal Adenocarcinoma

Start date: October 25, 2018
Phase: Phase 2
Study type: Interventional

The research product, registered as a nutritional supplement (Ocoxin®, oral solution), manufactured by Laboratorios Catalysis S. L., comes in the form of single-dose vials of 30 ml. It will be used at a rate of 60 ml daily (1 vial every 12 hours). Our main objective is To evaluate the effect of Ocoxin®-Viusid® on the quality of life of patients with metastatic colorectal adenocarcinoma. Our hypothesis is that the administration of the nutritional supplement Ocoxin®-Viusid® it is expected to improve the quality of life and enhance tolerance to chemotherapy in at least 70% of patients.

NCT ID: NCT03549494 Completed - Clinical trials for Head and Neck Neoplasms

Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction

Start date: October 25, 2018
Phase: Phase 2
Study type: Interventional

Our main objective is to evaluate the effect of Ocoxin-Viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. The Ocoxin-Viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with Chemotherapy.

NCT ID: NCT03543540 Completed - Celiac Disease Clinical Trials

Bioequivalence Study of Nexvax2 in Subjects With Celiac Disease

Start date: May 1, 2018
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled clinical study in non-homozygous human leukocyte antigen (HLA)-DQ.2.5+ adults with celiac disease (CeD).

NCT ID: NCT03535727 Completed - Neoplasms Clinical Trials

A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer

Start date: June 21, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.