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Digestive System Diseases clinical trials

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NCT ID: NCT02731664 Completed - Clinical trials for Functional Gastrointestinal Disorders

GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans

GLPMOT
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach, duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper gastrointestinal tract in man.

NCT ID: NCT02719496 Completed - Clinical trials for Gastrointestinal Disorders in Parkinson's Disease

Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease

PHYTOPARK
Start date: April 2016
Phase: Phase 2
Study type: Interventional

The main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.

NCT ID: NCT02690376 Completed - Clinical trials for Gastrointestinal Diseases

An Observer Blinded Comparison of MACE and Conventional Upper Gastrointestinal Endoscopy in Upper GI Bleeding

MACE
Start date: March 2016
Phase: N/A
Study type: Interventional

Gastroscopy (OGD) is a useful test for investigating a variety of suspected upper GI disorders. But it is uncomfortable for patients and incurs the risk of intubation and sedation, plus a large proportion of procedures reveal insignificant or no pathology. Capsule endoscopy (CE) is the investigation of choice for diseases of the small bowel. It is safe, non-invasive and well-tolerated. The use of CE is traditionally restricted to the small bowel, although newer capsules to image the oesophagus and colon are currently in use. Previous capsules have failed to adequately image the stomach due to its' large volume and rugal folds. Recently a magnetic capsule and handheld magnet has been developed (Mirocam Navi, Intromedic Ltd, Seoul, Korea) to enable an element of manoeuvrability of the capsule. This is unnecessary in the small bowel where the capsule is propelled along its' tubular structure by peristalsis, but in the capacious stomach this may allow the capsule to be steered to examine all areas of the stomach. We have already conducted two feasibility studies in porcine models with promising results and a trial has already evaluated the equipment to steer the small bowel capsule through the stomach into the duodenum. An ongoing study is comparing the ability of this technique to examine the stomach against conventional OGD, in patients with recurrent iron deficiency anaemia. The next stop would be to compare the two modalities under other different conditions. We wish to undertake a prospective single blind controlled trial comparing magnetically assisted capsule examination to conventional OGD in diagnosing upper gastrointestinal pathology in patients with gastrointestinal bleeding.

NCT ID: NCT02668679 Completed - Clinical trials for Gastrointestinal Diseases

The Effect of Dream Doctors in Children Undergoing Digestive Endoscopic Procedures

Start date: March 30, 2016
Phase: N/A
Study type: Interventional

Background: Performance of endoscopy in children requires more patience, experience, and expertise than in adults. The anxiety of the children is related to parent's separation, loss of self-control, unknown surroundings and strange people that are taking care of them, and frequently unpleasant or even painful procedures. Painful and frightening procedures in children have been shown to result in short-term physiologic changes and long-term behavioral changes. The response to unpleasant stimuli with stress and fear may be exaggerated in children and experienced as pain. Most infants and children and many teenagers need deep sedation or light general anesthesia to complete a successful and safe procedure. Induction of general anesthesia is a stressful procedure itself. Strategies to reduce preanesthesia anxiety include pharmacologic and non-pharmacologic interventions. However, this evidence is based mainly on self reports rather than objective measurements. Therefore, objective and non-invasive measurements to be utilized in the current study, should provide an assessment tools regardless the children's age. Multiple studies, beginning in the 1970's, have shown that humor has many positive effects on physical and mental health and well-being. Previous investigations have reported that humor has beneficial effects on the immune system, stress related to potentially fatal illnesses, pain tolerance, and mental functions. Dream doctors (DDs) are professional medical clowns or stage artists, who received training specifically to understand medical patient's need and to give the patient adjuvant therapy during hospital admissions or ambulatory treatment.The Israel dream doctors project, integrates professional medical clowning into the medical services provided at Israeli hospitals.Studies already proved that presence of medical clowns significantly reduces the level of anxiety during induction of anesthesia in children. Hypothesis of the study: 1) DDs lessen the level of anxiety and attention impairment in children undergoing gastroscopies. 2) DDs improve the satisfaction of children and their parents during gastroscopies. The aim of this study is: 1) To explore the influence of DDs on the satisfaction of children and their parents undergoing gastroscopy, utilizing questioners. 2) To explore the effects of DDs on anxiety and attention of children and their parents, undergoing gastroscopies by means of GSR, startle response and pre-pulse inhibition (PPI) tests, as well as , and measuring anxiety-related biologic indices.

NCT ID: NCT02657668 Completed - Clinical trials for Functional Gastrointestinal Disorders

Emotion Focused Therapy in Irritable Bowel Syndrome Patients

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

The study was quasi-experimental including patients in two intervention and control groups. Three measurements were done: pretest, post-test, and a two-months follow-up. The study population included patients with irritable bowel syndrome(diagnosed by specialists and based on the criteria of Rome III), who referred to a general Hospital. Fifty two irritable bowel syndrome patients were selected and assigned to two experiment (26 cases) and control (26 cases) groups. The criteria below were considered in selection of patients. Inclusion criteria: 1) Patients should not have participated in other psychological interventions concurrently; 2) Participants had not reported diagnosis of non-functional gastrointestinal illnesses. 3) Women patients had not been in pregnancy; 4) Participants had not met diagnosis of schizophrenia and bipolar disorders. Exclusion criteria: Three or more absences in the group sessions Co-variate variables: 1) demo-graphical variables (age, birth order, and education); 2) clinical variables (global psychological status, mind-body attribution, and duration of disease).

NCT ID: NCT02651857 Completed - Clinical trials for Gastrointestinal Diseases

Exploratory Study of Upper and Lower Endoscopic Fuse System

Start date: November 2015
Phase: N/A
Study type: Interventional

Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic Systems Utilizing EndoChoice's Full Spectrum Optical Technology

NCT ID: NCT02647866 Completed - Ulcerative Colitis Clinical Trials

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.

NCT ID: NCT02614313 Completed - Clinical trials for Irritable Bowel Syndrome

Fructose Breath-testing in Irritable Bowel Syndrome (IBS)

Start date: June 2016
Phase: N/A
Study type: Interventional

Background: Breath testing for food intolerances is becoming routine in patients with functional gastrointestinal disorders (FGID). Both FGID and saccharide intolerances (FODMAPs: fermentable oligo-, di-, polysaccharide and polyols, e.g. lactose, fructose, sorbitol) are common (>10% of any given population) and often respond to dietary modification. The breath tests are based on quantification of gas excretion in breath as a sign of malabsorption and symptom provocation, but are likely subject to considerable psychological bias. The role of expectation and other psychological effects on breath testing has not been reported, but is crucial for the validation of these increasingly wide-spread tests with considerable dietary and potentially deleterious consequences. Fructose has been shown to result in short term pro-inflammatory metabolic responses, but these effects have not been studied as underlying causes for intolerance symptoms in fructose intolerant patients with FGID. Aim: To investigate the psychological component and the short-term metabolic effects of fructose breath testing in patients referred for evaluation of FGID using placebo. Additionally, to assess baseline predictors for a positive breath test result. Methods: Fructose intolerance (defined by a positive symptom index) and malabsorption (defined by increased breath hydrogen/methane concentrations) will be determined in 30 successive male and female FGID in a single centre using breath-testing. Fructose 35g, given double-blind as well as open, a sweet placebo (cyclamate/saccharine; Assugrin®) and a neutral (still water) placebo given double-blind will be compared in a randomized, cross-over sequence and according to our standardised procedure on four separate study days. Symptoms will be recorded using standardised questionnaires and breath concentrations of H2 and CH4 will be measured during testing on the four study days. Somatisation and psychological profiles will be assessed by questionnaires. Blood samples will be obtained before and during provocation testing to assess short-term responses to fructose loading by metabolomics. Fructose, blinded and open, and placebo responses will be compared and baseline predictors for a positive breath tests assessed.

NCT ID: NCT02610816 Completed - Clinical trials for Eosinophilic Esophagitis

Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids

Start date: March 21, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this interventional study is to test and compare the effectiveness of two elimination diets—the 1-food elimination diet (1FED, milk only) and the 4-food elimination diet (4FED, milk, egg, wheat, and soy) for eosinophilic esophagitis (EoE). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.

NCT ID: NCT02605395 Completed - Clinical trials for Gastrointestinal Diseases

Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions

Start date: March 22, 2014
Phase: Phase 4
Study type: Interventional

This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions. In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1. PARIET is a registered trademark of EISAI Co. Limited.