View clinical trials related to Diarrhea.
Filter by:This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.
Zambia recently introduced routine infant immunization against rotavirus - the most important cause of severe gastroenteritis and diarrhoea mortality in children. Although vaccines like Rotarix are a cost effective tool against infectious diseases, live oral vaccines can be less immunogenic and efficacious in developing world settings as compared with industrialized countries. Reasons behind this phenomenon are not well understood, but may relate to continued maternal antigen exposure and high level maternal immunity that is passed to the foetus/newborn transplacentally and/or through breast milk. Therefore, three arising hypotheses include: (i) high-level rotavirus-specific maternal immunity (in the form of anti-rotavirus breast-milk immunoglobulin A (IgA) and transplacental serum IgG) is a major contributor to failed seroconversion following infant vaccination. (ii) Malnutrition negatively impacts infant immunity and increases the risk of post-vaccination rotavirus gastroenteritis. (iii) Introduction of rotavirus vaccine will alter the molecular epidemiology of circulating rotavirus strains detected in vaccinated children presenting with severe diarrhea. To address these hypotheses, the proposed study will recruit a prospective cohort of 420 mother-infant pairs. These will be enrolled at the time of vaccination and followed for up to four years. Baseline immunological status will be ascertained and seroconversion rates determined a month after full immunization. Incident rotavirus gastroenteritis will be monitored in the vaccinated infants whenever episodes of diarrhoea occur; through this surveillance, the sero-strains of rotaviruses causing disease will be tracked over the four year period. Contributions of HIV infection both in mothers and infants, vitamin A and zinc deficiency, weight for age Z-scores as well as mid upper arm circumference will also be assessed. Knowledge gained from this study will inform future interventional trials on strategies to improve rotavirus vaccine effectiveness in the developing world.
We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea in a population of general inpatients who are receiving antibiotics.
To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with some dehydration, vomiting and diarrhea in Pakistan. SOME Dehydration is defined as 2 or more of the following signs and symptoms: - Restlessness, irritability - Sunken Eyes - Drinks eagerly, thirsty - Skin pinch goes back slowly
The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with vomiting and diarrhea in Pakistan.
The study is on indefinite HOLD due to the loss of funding that occurred during the pandemic emergency. Subsequently, a key collaborator left our institution, and as a near-term result, the protocol awaits reactivation. Three patient subjects were enrolled, all 3 patients/subjects were cured of the infection, and there were no adverse events or sequelae observed or reported. The aim of the study continues to confirm and extend the work of Trede and Rask-Madsen (Lancet 1989;1:1156-1160) that administration of a defined fecal microbiota will lead to rapid and sustained resolution of C. difficile-associated chronic relapsing diarrhea. FDA required 4 non-geriatric qualified patients to be studied before including the elderly. However, C. difficile-associated chronic relapsing diarrheal illness is predominantly a disease of the elderly, so this requirement GREATLY impeded timely enrollment. No protocol deviations have occurred. The current rationale behind FMT for CDI is that the introduction of microbes from a healthy donor should allow for the restoration of a normal microbial community in the diseased host with consequent suppression of C. difficile colonization and disease pathogenesis. The first modern use of FMT was reported in a 1958 case series of 4 patients with pseudomembranous enterocolitis. The first case of confirmed CDI treated with FMT was reported in 1983; treatment was curative. Until 1989, retention enemas were the most common technique for FMT. Alternative methods for delivering FMT have included fecal infusion via duodenal tube (1991), rectal tube (1994), and colonoscopy (1998). FMT for recurrent CDI has been used successfully, whether administered by nasogastric tube, rectal administration by colonoscopy, or rectal tube, including self-administration at home by enema. FMT has proven to be remarkably effective and remarkably safe without any significant problems (see below and attached reviews and meta-analyses). Increasing interest is emerging regarding the changes in the intestinal microbiota associated with CDI. In 2008 Chang et al. constructed small (< 200 sequences per subject) 16S rRNA gene libraries from the stools of 4 patients with first-time CDI and 3 patients with recurrent CDI. Based on 16S rRNA gene classification, they found that the fecal microbiomes of patients with an initial episode of CDI were similar at the phylum level to healthy subjects (i.e., the majority of sequences belonged to dominant fecal phyla Bacteroidetes and Firmicutes), while a major reduction or loss of Bacteroidetes was observed in patients with recurrent CDI. The loss of the Bacteroidetes was accompanied by the expansion of other phyla, including Proteobacteria and Verrucomicrobia, which are normally minor constituents of the fecal microbiota. Khoruts et al. (2010) compared the microbiota of a patient with recurrent CDI before and after FMT by using terminal-restriction fragment length polymorphism and clone-based 16S rRNA gene sequencing. Before transplantation, the patient's microbiota was deficient in members of Bacteroides and instead was composed of atypical fecal genera such as Veillonella, Clostridium, Lactobacillus, Streptococcus, and unclassified bacteria similar to Erysipelothrix. Two weeks after the infusion of donor fecal suspension, the bacterial composition of her feces approached normal and was dominated by Bacteroides sp. strains. In 1989, Tvede and Rask-Madsen used a combination of nine normal fecal organisms to treat 6 patients with chronic relapsing C. difficile diarrhea. These investigators cultivated 10 strains of bacteria, including Enterococcus (Streptococcus) faecalis (1108-2), Clostridium inoculum (A27-24), Clostridium ramosum (A3I-3), Bacteroides ovatus (A40-4), Bacteroides vulgatus (A33-14), Bacteroides thetaiotaomicron (A33-12), Escherichia coli (1109), E. coli (1108-1), Clostridium bifermentans (A27-6), and Blautia producta (Peptostreptococcus productus) (1108-2) in broth for 48 h to a concentration of approximately 10 to the 9th power bacteria/mL. Two mL from each bacterial culture were admixed with 180 mL saline that had been pretreated in an anaerobic chamber for 24 h; the bacterial suspension was then instilled rectally. This procedure was followed promptly by a decline of C. difficile to undetectable levels by culture and the loss of detectable toxin from the stools. Normal bowel function was restored within 24 hours, and abdominal symptoms disappeared. Stool cultures and toxin assays for C. difficile remained negative during a year of follow-up. It is especially important to note that feces from none of the 6 patients contained Bacteroides sp.
Triaging new pediatric gastroenterology consultations is challenging as both inflammatory and non-inflammatory gastrointestinal (GI) diseases can present with non-specific chronic abdominal pain and/or diarrhea. Examples of inflammatory GI diseases include Crohn's disease, ulcerative colitis and celiac disease and non-inflammatory GI diseases lactose intolerance, irritable bowel syndrome and non-ulcer dyspepsia. Inflammatory GI diseases require different investigations and treatment than non-inflammatory GI diseases and ideally, would be identified early. Higher priority triage of these patients would allow timely organization of further investigations including pertinent laboratory testing, radiologic studies and gastrointestinal endoscopies. These more invasive procedures are not needed in most patients presenting with non-specific gastrointestinal symptoms. Therefore, the investigators do not routinely ask for screening laboratory testing or other studies in children referred to our clinic. Non-invasive screening tests for GI disorders may aid in appropriately triaging new consultations to pediatric gastroenterology. Calprotectin is a protein found in inflammatory cells called neutrophils. The concentration of calprotectin in stool reflects the presence of an inflammatory process occurring in the GI tract. Thus, testing for calprotectin has been proposed as a potentially useful test for detecting some inflammatory GI diseases, most notably Crohn's disease and ulcerative colitis. Alternatively, a simple gastrointestinal questionnaire of "red flag" symptoms and family history of GI disorders may also be of benefit. The investigators hypothesize that the use of fecal calprotectin and a screening GI questionnaire will aid in identifying children at higher risk of an inflammatory GI disorder. Subsequently, higher priority triaging of these patients will decrease the time to diagnosis of inflammatory GI disease. This will be a single centre, stratified, randomized clinical trial conducted in Kingston, Ontario, Canada. Patients referred to the pediatric gastroenterology service without a known diagnosis for non-specific chronic abdominal pain and/or diarrhea will be asked to participate in the study. All patients who meet the inclusion criteria will be consented by telephone with a standard form. Consenting patients will be mailed the GI questionnaire and the fecal calprotectin test kit. The fecal calprotectin test kid includes instructions, a stool collection kit and return postage. All patients will be given the next available appointment with a pediatric gastroenterologist. Patients will then be randomized to receive either usual care (50%, 40 patients) or to have a screening fecal calprotectin (FC) measurement (50%, 40 patients). Patients in the FC group will have FC measured by the Quantum Blue® Rapid Calprotectin Assay. If the calprotectin level is high (above 50 μg/g), the patient will be contacted again by telephone and given a new appointment time (within 14 working days). This study may have a positive impact by demonstrating a novel method for decreasing the time to diagnosis of inflammatory GI disease.
Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (<200 ug/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.
The incidence risk of colorectal cancer （CRC） is increasing at 4.2% year by year in China. Most effective way to reduce the death rate of CRC patients is to diagnose in quite an early stage. QiaoKou District is a chemical industry Zone of Wuhan with a long history, which has few data of CRC epidemiology. The investigators design the primary CRC screening for this district by healthy questionnaire, Fecal Occult Blood Test(FOBT) and colonoscopy. HanYang Areo has been chosen as Control for its non-industry environment.The crowd would be screen biennially. The high risk group would be intervened, such as resection of polyps or other specific treatment. A follow-up registration database has been built for analysis the relationship between incidence or death rate to high risk factors, such as age, life environment, lifestyles, base diseases and family history of cancer. This study will provide some epidemiology dates of CRC to the local Government, and assist the governor to built a more effective screening system of CRC.