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Intestinal Diseases clinical trials

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NCT ID: NCT02248337 Completed - Clinical trials for Inflammatory Bowel Disease

Low Volume Colon Preparation for IBD

Start date: March 2013
Phase: Phase 4
Study type: Interventional

Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.

NCT ID: NCT02246647 Completed - Clinical trials for Irritable Bowel Syndrome

Biomarkers for Intestinal Permeability in Patients With Constipation

Start date: September 2014
Phase:
Study type: Observational

Our overall objective with this study is firstly to provide a comprehensive assessment of intestinal permeability, mucosal barrier function using existing biomarkers and secondly to explore novel biomarkers for measuring intestinal permeability in patients with constipation predominant Irritable Bowel Syndrome (IBS-C).

NCT ID: NCT02227602 Completed - Ulcerative Colitis Clinical Trials

Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease

Start date: January 2014
Phase: N/A
Study type: Interventional

Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy of mangoes has not previously been compared with respect to mild inflammatory bowel disease. In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step. Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would have a significant impact on public health.

NCT ID: NCT02222584 Completed - Clinical trials for Inflammatory Bowel Disease

The Effects of Physical Activity on Patients With Inflammatory Bowel Disease

Start date: July 2014
Phase:
Study type: Observational

Physical activity (PA) is beneficial in the prevention and management of chronic disease. However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the effect of PA on quality of life of patients with IBD.

NCT ID: NCT02199496 Completed - CVID Enteropathy Clinical Trials

Study of Safety, Tolerability, and Efficacy of Ustekinumab for Symptomatic Gastrointestinal Inflammation Associated With Common Variable Immunodeficiency

Start date: October 19, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Some people with Common Variable Immunodeficiency Disease (CVID) have gastrointestinal inflammation. This can cause diarrhea, weight loss, and not being able to absorb nutrition from food. Researchers want to see if the drug ustekinumab can help these problems. This drug blocks some proteins that cause inflammation. Objective: - To test the safety and efficacy of the drug ustekinumab for people with CVID with gastrointestinal inflammation. Eligibility: - Adults ages 18-75 with CVID. They must have chronic diarrhea, have unintentionally lost weight in the last year, and/or need to use nutritional supplements to maintain their weight. Design: Participants will undergo the following screening studies to make sure that this study is a good fit for your medical situation, and to make sure it is safe for you to receive the study medications tests, including tests for HIV and hepatitis . This will be done as an inpatient at the NIH Clinical Center and takes about 5-6 days: - Participants will be screened with: - Medical history - Physical exam - Blood tests, including tests for HIV and hepatitis. - Stool tests, including a timed 48 hour collection for fat malabsorption and a 24 hour collection for protein malabsorption - Urine tests, including a pregnancy test for any women with the ability to have a child - Chest CT scan to look for infection - D-xylose testing, which involves drinking a sugary solution and then having a blood sample drawn to test carbohydrate (sugar) malabsorption - Hydrogen breath testing for test for small intestinal bacterial overgrowth (SIBO) this test also involves drinking a sugary solution and then collecting breath samples - Upper endoscopy (EGD) and/or colonoscopy to look at the lining of the GI tract and take biopsies for testing. This will be done under sedation by a qualified gastroenterologist. Participants who complete screening and meet all criteria will then return to the NIH Clinical Center for the following visits: - First Treatment Visit (1 clinic day): Medical history, physical exam, measurement of vital signs and weight, review of medications, and an assessment of number and consistency of stools each day. A pregnancy test for women of childbearing potential. A nurse will give you three shots of 90 mg ustekinumab (270 mg total dose) by very small needles injected under the skin, and then observe you for 1 hour. - Week 8 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of vital signs and weight, review of medications, and an assessment of number and consistency of stools each day. Blood, urine and stool samples will be collected. A pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very small needle injected under the skin, and then observe you for 1 hour. - Week 16 Treatment Visit (1 clinic day): Medical history, physical exam, measurement of vital signs and weight, review of medications, and an assessment of number and consistency of stools each day. Blood, urine and stool samples will be collected. A pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very small needle injected under the skin, and then observe you for 1 hour. - Week 24 Treatment and Mid-point Evaluation Visit (4-6 inpatient days): Medical history, physical exam, measurement of vital signs and weight, review of medications, and an assessment of number and consistency of stools each day. Blood, urine and stool samples will be collected, including repeating the d-xylose carbohydrate malabsorption testing, the 24 hour stool collection for protein malabsorption and the 48 hour stool collection for fat malabsorption. A pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very small needle injected under the skin, and then observe you for 1 hour. - Week 32 Treatment Visit: Medical history, physical exam, measurement of vital signs and weight, review of medications, and an assessment of number and consistency of stools each day. Blood, urine and stool samples will be collected. A pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very small needle injected under the skin, and then observe you for 1 hour. - Week 40 Treatment Visit: Medical history, physical exam, measurement of vital signs and weight, review of medications, and an assessment of number and consistency of stools each day. Blood, urine and stool samples will be collected. A pregnancy test for women of childbearing potential. A nurse will give you one 90 mg dose of ustekinumab by a very small needle injected under the skin, and then observe you for 1 hour. - Week 48 ...

NCT ID: NCT02182947 Completed - IBD Clinical Trials

Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children

CE
Start date: August 2012
Phase: N/A
Study type: Interventional

Most of the studies evaluating the roles of MRE and WCE conducted in pediatric patients have been retrospective with the main goal of making a diagnosis in patients with suspected IBD. The current study is the first prospective study in children with known IBD assessing the roles of MRE and WCE in identifying disease exacerbation. This study will help to identify if capsule endoscopy is superior or complementary to MRE in the evaluation of suspected disease exacerbation in IBD patients.

NCT ID: NCT02181153 Completed - Clinical trials for Inflammatory Bowel Disease

Genetic, Serological Fecal and Clinical Markers in Siblings of Children With Inflammatory Bowel Disease

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

Although the precise etiology of inflammatory bowel disease (IBD) is still unknown, over the last decade active research allowed to gain more precise insights in the pathophysiology of IBD indicating that the chronic inflammation of the intestinal mucosa is directed against the microbiota of the gut in particularly susceptible individuals. Genetic studies and more recently genome-wide association studies (GWAS) have allowed to identify over 70 susceptibility genes which confer an increased risk of developing IBD. In the last years the attention of researchers has shifted to the identification of the early immunological changes that occur already at a preclinical stage of the disease, trying also at identifying the disease before it shows itself. Recently, the ability of a combination of serological markers in predicting the development of IBD has been demonstrated in adults. However, there are no studies evaluating a cohort of children at high risk for the disease, in whom the first immunological changes underlying the development of IBD could be studied, including a combination of genetic, serological, fecal and clinical markers. The purpose of this study is to evaluate in a population genetically well-characterized, as siblings and twins of patients affected with IBD, early genetic, serologic, fecal and clinical markers of disease, which may be present even years before developing the disease. The identification of these markers in predisposed individuals could help to implement strategies for prevention or early treatment to modify the natural history of IBD.

NCT ID: NCT02179372 Completed - Ulcerative Colitis Clinical Trials

Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Start date: June 2014
Phase: N/A
Study type: Interventional

The aim of this study is to test Eicosapentaenoic free fatty acid's effects on calprotectin levels in IBD patients in clinical remission. During the study fecal calprotectin levels will be measured every 3 months and clinical flares will be registered.

NCT ID: NCT02173002 Completed - Clinical trials for Inflammatory Bowel Disease

Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial

myIBDcoach
Start date: July 2014
Phase: N/A
Study type: Interventional

Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young people. The disease is characterized by a heterogenic phenotype and the disease course by flares and remissions. As in most chronic diseases the economic burden of IBD is important due to direct health care costs and disability. Health care reorganization for IBD patients in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal inflammation results in irreversible bowel damage and complications and none of the presently available drugs is effective for all patients and many drugs have possible severe side effects. To prevent complications of the disease and side effects IBD should be monitored carefully. In the Netherlands however there is a shortage of gastroenterologists where the incidence of IBD is rising. Secondly evidence exists that direct involvement of health care workers, patient empowerment and integrated care can improve the outcome of chronic diseases. Thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not systematically followed in routine care. Finally the government demands registration of efficacy endpoints for expensive drugs in the near future. Therefore the investigators developed a web-based Telemedicine tool for IBD patients in collaboration with the Dutch IBD patient's organization (CCUVN). "myIBcoach" contains E-learning modules, monitors disease activity, disability, quality of life, adherence, infections, smoking status, side effects, stress and malnutrition on fixed time points with validated questionnaires, allows the patient to communicate with health care workers and gives feedback to the back office and the patient. A feasibility study in 30 IBD patients in 3 centres showed a high satisfaction and compliance of IBD-patients and health care workers with this telemedicine tool. The aim of this study is to compare standard care for IBD patients in 3 hospitals with a care via the telemedicine tool myIBDcoach.

NCT ID: NCT02162862 Completed - Fatigue Clinical Trials

Treating Disrupted Sleep in Individuals With Inflammatory Bowel Disease

Start date: July 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if either a targeted type of talk therapy (Phase I) or medication, Wellbutrin, (Phase II) improve sleep disturbance and/or fatigue in individuals with Inflammatory Bowel Disease (IBD).