View clinical trials related to Inflammatory Bowel Diseases.
Filter by:Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about 8 hours. During this time the capsule takes pictures as it passes through the small bowel. In about 15-20% of capsule tests the battery expires before the capsule passes through the entire small bowel into the colon. Incomplete tests indicate that a variable portion of small bowel was not visualized. Incomplete tests are associated with potential missing of abnormalities in the portion of small bowel that was not reached. The capsule test may often required to be repeated but the problem of incomplete examination may persist. At present no medication has been approved to increase the rate of complete capsule tests. Prucalopride is a medication that has been approved in Canada and Europe for the treatment of chronic idiopathic constipation. Animal and human studies suggested that prucalopride may enhance the movement of the stomach and the small bowel. A recent presentation at a medical meeting suggested that prucalopride may accelerate the passage of the capsule camera through the small bowel without increasing the chance to miss a lesion in the small bowel. The purpose of this study is to asses if the administration of a single dose of prucalopride is going to decrease the time required by the capsule to move through the small bowel.
Anemia is a clinical manifestation, which is commonly observed in patients with inflammatory bowel disease, and it accounts for significant loss in the quality of life of these patients. The aim of the current study is to assess the effect of orally administered iron treatment, as well as its response predictors in patients with inflammatory bowel disease who are in remission and present anemia. The study will recruit 100 patients with Crohn's disease (CD) and 100 patients with ulcerative colitis (UC) diagnosed and regularly monitored in the Inflammatory Bowel Disease Center at the University Hospital of the Federal University of Juiz de Fora, for clinical, hematological, biochemical and immunological assessment. Blood samples will be collected (10 ml) and the following tests will be performed in all the anemia patients (in remission) at the beginning of the treatment and 8 weeks later: complete blood count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocyte sedimentation rate (ESR) , transferrin saturation index, ferritin, serum iron, hepcidin, quantitative C-reactive protein (CRP), interleukin-6 (IL-6)) and fecal calprotectin. In addition, quality of life, anxiety and depression and fatigue questionnaires will be applied to the patients (IBDQ, HAD and Chalder). The World Health Organization (WHO) criteria will be used to diagnose anemia, therefore, hemoglobin lower than 12 g/dl for women and 13g/dl for men will be considered anemia; hemoglobin lower than 10 g/dl will be considered severe anemia. Patients with mild and moderate anemia in remission will be initially treated with oral iron (oral liposomal iron) and the occurrence of possible symptoms related to oral iron intolerance will be assessed, as well as the patients' disease activity level and quality of life. The patients in follow-up will be subjected to new laboratory tests after the eighth oral iron treatment week. The results of the current study are expected to help assessing the oral iron efficacy and response predictors, as well as the side effects of the treatment and its impact on the quality of life of patients.
Fatigue is a very frequently reported symptom in patients with inflammatory bowel disease (IBD), whether it is Crohn's disease (CD) or ulcerative colitis (UC). Sometimes the fatigue may be easily explained by other symptoms or tests which show that the disease is active. For example patients may be anaemic (have a low blood count) which can in itself lead to a feeling of being tired all the time. Treatment of the disease can make some of these patients feel less fatigued. However, 4 or 5 out of every 10 patients with IBD which is felt to be in remission (ie not active disease) report fatigue. This can have far-reaching implications for patients in their everyday lives, with issues around work or school, close relationships, travel and leisure being profoundly affected. The CCUK funded research on fatigue and IBD, led by Professor Christine Norton and Wladzia Czuber-Dochan at King's College London, has identified fatigue as being a significant issue facing patients and has also highlighted that few doctors offer help and support beyond treating the disease itself when active. This is partly because fatigue itself has been difficult to measure and so any study designed to treat fatigue would be limited by being unable to quantify any improvement in a meaningful way. Fortunately the King's College group have developed a 'fatigue score' which is a simple questionnaire that is able to quantify the severity of fatigue. The aim of our study is to assess the effect of a structured support and educational programme on the levels of fatigue in patients with inactive IBD who report moderate or severe levels of fatigue. A secondary component of our study is to see if there are any associations between fatigue levels and disease activity or other parameters such as quality of life, anxiety or symptoms of overlapping irritable bowel syndrome. Patients will be approached in the out-patient or telephone clinics and the study will be explained with written information and any questions will be answered. If they agree to being involved they will be asked to complete the fatigue and a number of other questionnaires in addition to having the standard assessment of symptoms, blood tests and a stool specimen. Patients with active disease will be excluded from the subsequent group interventions but the data they have provided to this point will still be helpful in our understanding of fatigue in IBD. Patients identified as being in remission following the initial assessments will be offered the opportunity to be involved in the next stage of the study. The stool samples will also be analysed for the microbiome ie which bacteria are present as some studies suggest that patients with IBD may have a reduced diversity of bacteria in their intestines. Half of this group will be randomised to active intervention and half will act as a control group for the rest of the study. The active intervention will involve completion of activity diaries over the following two weeks and then analysis of the diaries and agreement on behaviour changes designed to help fatigue. This will be supported by written information and three, monthly small group sessions to reinforce and support these changes. At the end of the study all patients will again complete the fatigue and quality of life questionnaires and have their disease activity assessed by symptom scores, blood and stool tests. The baseline results and the final results will be analysed to see if there is any improvement in fatigue in the group undergoing the programme of support and behaviour change. This is only a small pilot study but if it demonstrates that the intervention is feasible and may help with fatigue then a larger study will be performed to try and confirm our initial findings. Our ultimate aim is to find a simple intervention to empower patients to deal with the difficult task of living with IBD and the fatigue that this can bring.
This clinical trail intends to evaluate interventions based on the Infliximab trough levels for an individualized therapy adaption for pediatric IBD-patients undergoing anti-TNF-alpha-therapy. Main aim of the individualized strategy is to attain and maintain early disease control in order to keep as many patients as possible in disease remission, and to avoid primary and secondary therapy failure.
The objective of this study is to compare the efficacy of Infliximab-Biosimilar to Infliximab-Innovator and to demonstrate its noninferiority, in patients with ulcerative colitis or Crohn's disease in remission under treatment with infliximab up to 3 months.
In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica, Schweiz) and the well known polysomnographic equipment. Our hypothesises are: Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint). 1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints). 2. Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study. 3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns. 4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.
1. To evaluate the immune response to vaccines in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of IBD mother not treated with anti-TNF medications. 2. To evaluate the immune function of B and T cells at 3 months and one year of age in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of non anti-TNF treated mothers. The secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated with anti-TNF medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of IBD patients not treated with anti-TNF medications during pregnancy. Significance -The results of this study have the potential to change clinical practice of anti TNF treatment during pregnancy and the follow-up of infants born to these patients
The purpose of this study is to examine whether oral administration of Indigo Carmine together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used instead of staining during the examination itself.
Background Inflammatory Bowel Disease (IBD) is a group of lifelong and relapsing inflammatory conditions that usually affect the colon and the small intestine. Between 30 to 45% of patients with IBD do not take their treatment as prescribed by their health care team (Jackson, Clatworthy et al. 2010). The Perceptions and Practicalities Approach (PAPA) provides a theoretical framework to develop adherence interventions that are patient-centred (Horne, 2001). Unintentional non-adherence occurs when the patient wants to take the medication but there are barriers beyond their control, such as not understanding the instructions (practical barriers). Intentional non-adherence is the result of the beliefs affecting the patient's motivation to continue with treatment (perceptual barriers). Aims 1. To develop an internet-based intervention to address perceptual and practical barriers to adherence to medicine for IBD. 2. To determine whether the intervention is effective based on change in both types of barriers. Plan of Investigation The inclusion criteria are: age 18 or over; diagnosis of IBD; currently prescribed azathioprine, mesalazine, and/or adalimumab. 240 participants identified via Crohn's and Colitis UK and through two NHS IBD clinics will take part in the study. An online pilot Randomised Controlled Trial will allocate the participants either to a Cognitive Behavioural Therapy (CBT) based online intervention or Treatment as Usual group. On first visiting the website, participants will be screened for eligibility and asked for consent before answering the questionnaires. The website will assign intervention modules to be completed based on an individual's profile. Outcomes: Beliefs about Medicines scores will be measured at baseline, 1 month and 3 month follow-ups. Potential Impact A CBT based online intervention tailored to personal needs and concerns may benefit a large number of patients with low costs for the national healthcare services. A website can be accessed at a time and place convenient to the patient.
Inflammatory Bowel Disease (IBD) is an immune mediated chronic intestinal condition. It includes ulcerative colitis (UC) and Crohn's disease(CD). probiotics have been shown to be effective in varried clinical conditions ranging fron infantile diarrhea, necrotizing enterocolitis,helicobacter pylori infections, etc.