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Intestinal Diseases clinical trials

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NCT ID: NCT02472301 Completed - Clinical trials for Environmental Enteropathy

The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

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

To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.

NCT ID: NCT02472262 Completed - Enteropathy Clinical Trials

The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months

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

To determine if 6 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months to see if these improvements are correlated with specific changes in the enteric microbiome.

NCT ID: NCT02461758 Completed - Clinical trials for Inflammatory Bowel Disease (IBD)

Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients

Start date: October 2016
Phase: Phase 4
Study type: Interventional

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent epidemiological investigation estimates that nearly 4 million people worldwide are affected and approximately 1.4 million of these cases occur in the United States. IBD can lead to debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can achieve clinical remission and decrease the risk of complications, but also increase the risk for opportunistic infections, including influenza. Multiple studies have shown lower influenza vaccine responses in patients with IBD compared to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza serum antibody concentration correlates with protection from infection following vaccination. Therefore, increasing influenza antibody responses in patients with IBD would appear to be critical to improving protection from influenza. A high dose (HD) influenza vaccine containing four times more hemagglutinin was licensed based on its ability to induce higher antibody concentrations compared to standard dose (SD) in adults 65 years or older.

NCT ID: NCT02460705 Completed - Clinical trials for Inflammatory Bowel Disease

Fecal Microbiota Transplant for Inflammatory Bowel Disease

Start date: June 2015
Phase: Early Phase 1
Study type: Interventional

Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation. This is a prospective, open label pilot study in which patients with symptoms of Inflammatory bowel disease will receive FMT therapy delivered via colonoscopy. The investigators hypothesize that FMT is a safe and effective treatment for patients with inflammatory bowel disease. The aims are: 1. To determine if symptoms of inflammatory bowel disease can be successfully treated by Fecal Microbial Transplantation. 2. To determine if endoscopic appearance of colon or ileum improves following treatment by Fecal Microbial Transplantation.

NCT ID: NCT02453776 Completed - Clinical trials for Inflammatory Bowel Disease

Precision Dosing of Infliximab Versus Conventional Dosing of Infliximab

PRECISION
Start date: May 2015
Phase: Phase 4
Study type: Interventional

Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with inflammatory bowel disease (IBD). However, a large proportion of patients will eventually lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the outcome of IFX treatment.

NCT ID: NCT02445365 Completed - Clinical trials for Inflammatory Bowel Diseases

Remote Ischemic Conditioning in Patients With Ulcerative Colitis

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

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the time of diagnosis it is not possible to predict the course of the disease, which can range from a few flares in a lifetime to uncontrollable disease leading to hospitalization, surgery and stoma. There is a continuous need to improve treatment as well as diagnostic and prognostic tools. This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemic conditioning (RIC) in patients with moderate active ulcerative colitis (UC). The investigators hypothesize that RIC beyond the well known effect on reperfusion tissue damage has a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated brief and non-harmful suppression of blood circulation in a limb. The mechanism of action of RIC is likely to involve suppressed inflammation and cell death. Our study is a randomized clinical controlled study including 38 patients. Patients will receive RIC or sham for 10 consecutive days. The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopy findings, and various markers in the blood, faeces and the intestinal wall.

NCT ID: NCT02437591 Completed - Clinical trials for Inflammatory Bowel Disease (IBD)

Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

PROFILE
Start date: August 13, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI). This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

NCT ID: NCT02434133 Completed - Clinical trials for Inflammatory Bowel Disease (IBD)

Cross Sectional Study of Vaccine Antibody Response in Inflammatory Bowel Disease Patients

Start date: April 2015
Phase:
Study type: Observational

The investigators proposed study is the first of its kind. The investigators will measure measles, mumps, rubella, tetanus, diphtheria and pertussis antibodies in patients on the current IBD treatment modalities and compare the vaccine antibody concentrations and correlate them with time since immunization.

NCT ID: NCT02433470 Completed - Clinical trials for Inflammatory Bowel Disease

Association of Functional Changes in the Brain and the Perception of Pain in Patients With Chronic Inflammatory Bowel Diseases (IBD)

Start date: April 2015
Phase: Phase 2
Study type: Interventional

In the study the investigators aim to test whether transcranial direct current stimulation (tDCS)-induced pain reduction is in association with functional changes in the brain measured with magnetic resonance imaging (MRI) in patients with chronic inflammatory bowel diseases (IBD). Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via MRI.

NCT ID: NCT02423512 Completed - Ulcerative Colitis Clinical Trials

The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness

Start date: June 2015
Phase: N/A
Study type: Observational

Vedolizumab is a new medication being used for the treatment of Crohn's disease and Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7 lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous studies have shown that patients who have previous exposure to another type of medication for Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab as well as those who have never been exposed. This study will investigate biologic markers in the blood and tissue the help identify possible reasons for this difference.