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Intestinal Diseases clinical trials

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NCT ID: NCT02550860 Terminated - Intestinal Diseases Clinical Trials

Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function

Tewlip
Start date: January 2015
Phase: Phase 3
Study type: Interventional

The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term LCPN and help in electrolyte and water balance. The objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal barrier function will be assessed through the transepidermal water loss (TEWL) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE (SO-based or FO-containing) will be compared using a randomized double blind crossover design, using patients as their own control. Each IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and red blood cell EFA profile will be determinate in order to facilitate result interpretation.

NCT ID: NCT02481687 Terminated - Ulcerative Colitis Clinical Trials

The Value of I-Scan and Confocal Laser Endomicroscopy for the Assessment of Chronic Inflammatory Bowel Disease

I-Scan-CLE-IBD
Start date: June 2015
Phase: N/A
Study type: Observational

Recently, Confocal Laser Endomicroscopy (CLE) has been developed as a novel technique that actually enables in vivo microscopic analysis of the gastrointestinal tract, during ongoing endoscopy. The potential role of CLE has been explored in pathology of both upper and lower gastrointestinal tract, showing good accuracy for predicting the final histopathological diagnosis, based on immediate evaluation of tissue and vascular patterns. Because of its minute scanning area, this techology is best used in conjunction with other "red-flag" techniques to screen the mucosa for areas of interest, which can then be examined by CLE for a histological diagnosis. I-scan technology (Pentax, Tokyo, Japan) is a new image-enhanced endoscopic technique that can achieve a virtual chromoendoscopy, but until now there have been no studies to determine the role of this technology in the evaluation of activity in inflammatory bowel disease. The study protocol is based on comparing imaging findings of p-CLE in conjunction with I-scan endoscopy with activity score and histological diagnosis of inflammatory bowel disease. CLE might have an important role in IBD patients management, by assessing the inflammation, dysplasia or response to treatment.

NCT ID: NCT02461784 Terminated - Clinical trials for Inflammatory Bowel Disease (IBD)

The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease

Start date: January 21, 2016
Phase:
Study type: Observational

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC) which peak in incidence (rate or frequency) during the reproductive years. An increasing number of young people will face challenging decisions regarding medical management of this chronic disease during a period of time when they are still completing schooling, establishing their career, and/or are building a family. Treatment options for IBD consist of immunosuppressive therapy, such as immunomodulators (azathioprine and methotrexate). Methotrexate (MTX) is a folic acid antagonist (a substance that interferes with or inhibits the action of another). It is thought that MTX works by decreasing the inflammation in the gastrointestinal tract. MTX has been studied for many years and in used as treatment in not only IBD, but also in conditions such as rheumatoid arthritis and lupus. However, due to concerns about the safety of MTX, particularly in regards to fertility and pregnancy has limited its current use. Participants are invited to take part in this research project to determine whether the treatment of IBD patients with MTX is associated with an increased risk for infertility. Investigators will recruit 75 male IBD patients under MTX treatment for their IBD as well as 75 healthy male controls for a total of 150 patients at the University of Wisconsin Hospital & Clinics.

NCT ID: NCT02391012 Terminated - Clinical trials for Inflammatory Bowel Disease

Fecal Transplantation for Inflammatory Bowel Disease

FMT IBD
Start date: April 2015
Phase: Phase 1
Study type: Interventional

Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy intestine as a probiotic preparation. The feces of a healthy individual is fluidized and than inserted into the intestinal tract of a sick individual, assuming that the healthy flora will colonize and cure the intestine. There are reports of the efficacy of this treatment for inflammatory bowel disease but currently the numbers are small. aim: To investigate whether use of FMT will bring improvement for colitis in IBD patients . Methods: The patients will undergo full colonoscopy, the stool preparation will be infused through the colonoscope during withdrawal of the instrument.

NCT ID: NCT02255227 Terminated - Clinical trials for Bowel Diseases, Inflammatory

Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD

PneumoMICI
Start date: April 13, 2015
Phase: Phase 2
Study type: Interventional

This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients. Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies.

NCT ID: NCT02242084 Terminated - Clinical trials for Motor Weakness in Two or Four Limbs

Thrombolysis in Ischemic Spinal Cord Stroke

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

Ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (CNS). In most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%. Ischemic stroke of the spinal cord can arise from: 1. Dissection of the aorta. 2. Aneurism in the aorta. 3. Atherosclerotic disease of the aorta or vertebral arteries. 4. Spinal surgeries. 5. Spinal AVM. 6. Embolism from cardiac origin. 7. Occlusion of radicular artery. Onset is usually sudden, reaching maximal intensity in hours until the patient becomes paralyzed in two or in all four limbs. In most cases the damage is in the Anterior Spinal Artery (ASA). The disease is expressed with motor weakness accompanied by disturbance of temperature and superficial sensation, urinary retention or bowel disorder, with preserved position and vibration sense. The differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis of the spinal cord or acute demyelinating polyneuropathy like Guillan Barree Syndrome (GBS). Therefore in order to reach the appropriate diagnosis in most cases an urgent MRI of the spinal cord is necessary upon arrival in the emergency department. One of the treatments to acute ischemic stroke is providing thrombolysis. As tested and validated in numerous studies for ischemic events in the brain, until today no validated study in ischemic spinal stroke using thrombolysis has been completed.

NCT ID: NCT02232373 Terminated - Clinical trials for Functional Gastrointestinal Disorders

Campylobacter Enteritis and PI-BD: Dietary Reduction in Carbohydrates

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

The purpose of the study is explore the issues that relate to testing a particular dietary treatment, the low FODMAP diet, in a randomised trial using an appropriate control diet with which to compare it. In this trial the investigators will look at its effect on symptoms of people with persistent disturbance in their bowel pattern 3 months after an intestinal infection with Campylobacter. The investigators will also look at the changes in gut bacteria that occur with the diet.

NCT ID: NCT02163187 Terminated - Rectal Cancer Clinical Trials

Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

Start date: June 10, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device. Neuromodulation is a way of changing the activity of the nervous system by using electrical stimulation. InterStimTM is FDA approved to help people who have a hard time controlling their bowl movements. This is called fecal incontinence.The device is placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is initially tested to make sure it will work using a temporary wire and then, if successful, the device is permanently implanted.

NCT ID: NCT02128503 Terminated - Ulcerative Colitis Clinical Trials

Prevalence and Clinical Course of Chronic Hep B Infection in IBD and Rheumatologic Disease

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

This study aims to determine the prevalence of HBV infection in patients with IBD and rheumatologic disease, and to assess the impact of immunosuppressive therapy on viral load and clinical course of IBD patients.

NCT ID: NCT02013505 Terminated - Bowel Dysfunction Clinical Trials

A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy

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

The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.