View clinical trials related to Diarrhea.
Filter by:This study is to determine the feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human colon under the real time monitoring by colonoscopy in the clinical application.
D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
Healthcare delivery now mandates shorter visits with higher documentation requirements, undermining the patient-provider interaction. Electronic health records (EHRs) have the potential to improve outcomes and quality of care in this pressured environment, and are endorsed by the Patient Protection and Affordable Care Act (ACA) and Health Information Technology for Economic and Clinical Health (HITECH) Act as an important mechanism to support value-based healthcare. However, EHR systems were principally designed to support the transactional needs of administrators and billers, less so to nurture the relationship between patients and their providers. The purpose of this research is to identify ways to use EHRs to support clinical gastroenterologists and their patients while meeting the meaningful use requirements of the HITECH Act. To improve clinic visit efficiency and meet criteria for meaningful use, investigators developed a patient-provider portal (P3) that systematically collects patient symptoms using a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS utilizes computerized adaptive testing (CAT) to guide patients through questions drawn from a library of over 300 symptom attributes measuring the timing, severity, frequency, location, quality, and character of their GI symptoms, along with relevant comorbidities, family history, and alarm features. The system then automatically "translates" the patient report into a full narrative HPI available for use by GI providers in an EHR. In a cross-sectional study in the American Journal of Gastroenterology comparing AEGIS versus physician-documented HPIs, investigators found that blinded physician reviewers perceived that AEGIS HPIs were of higher overall quality, better organized, and more succinct, comprehensible, complete and useful compared to HPIs written by physicians during usual care in academic GI clinics. In the current study, investigators aim to evaluate computer-generated HPIs prospectively on a wider scale in diverse academic and community-based settings. Moreover, investigators aim to test an enhanced AEGIS intervention that ties patient HPIs to an individualized "education prescription" which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments.
The primary objective is to demonstrate rifaximin 200 milligrams (mg) tablets (test) and Xifaxan® 200 mg tablets (reference) are clinically bioequivalent with respect to the clinical cure rates when administered 3 times a day (TID) for 3 days in participants with travelers' diarrhea.
The purpose of this study is to develop evidence on the relative efficacy of 2 rifaximin chemoprophylaxis regimens for the prevention of Travelers' Diarrhea (TD) in a deployed setting. An additional purpose is to explore the effect of chemoprophylaxis on microbial flora and antimicrobial resistance, and obtain parameter estimates to inform a cost-effectiveness model of chemoprophylaxis in prevention of TD. Information from this study will be used to develop management guidelines for the prevention of TD among deployed (United States (US) and United Kingdom (UK) military personnel. The study will be a multi-site, randomized, placebo-controlled, double-blind, clinical trial among deployed military personnel. The study will test 2 TD chemoprophylaxis regimens (once daily versus twice daily) of the same antibiotic, rifaximin, compared to a placebo. For the proposed chemoprophylaxis study described herein, cohorts of military personnel (US and UK) deploying/traveling overseas will be recruited prior to travel to participate and will undergo enrollment procedures as outlined in study appendices. Subjects who are eligible and agree to participate will be randomized to receive one of 3 regimens: (1) rifaximin 550 mg daily; (2) rifaximin 550 mg twice a day; or (3) placebo, to be taken while deployed. Chemoprophylaxis will be maintained for duration of travel or a predetermined period of up to 6 weeks and at least 2 weeks, which may include a period of up to 5 days of use after return to COO for deployments less than 6 weeks in duration. Clinical and laboratory data will be obtained before, during if available and after deployment/chemoprophylaxis.
Melghat is poorly developed tribal area in India with very high child mortality & malnutrition prevalence (grossly inadequate medical facilities). Important health problems. Malnutrition , Pneumonia, Tuberculosis, Anaemia, Malaria, Diarrhoea, Premature and L. B. W. babies, Neonatal sepsis, Feeding problem, Birth asphyxia. The investigators developed a Home Based Child Care (HBCC) model to reduce neonatal mortality rate (NMR), infant mortality rate (IMR), under 5 mortality rate (U5MR) and severe malnutrition(SM) in this region. Melghat. Need of project : Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India. Methodology: RCT-Home based child care (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages. Strengthening of existing government ICDS and health system. Melghat. Need of project : Melghat is known for highest U5MR in Maharashtra. Overall aims and importance of the research:. The results obtained in this area will be applicable for reducing children mortality and malnutrition in other parts of Melghat and all other tribal areas of India. Methodology: RCT- (HBCC) by trained village health workers .(ARI, Diarrhoea, Malaria clinically & Neonatal care) in 19 villages.
Diarrhea is a common problem in the pediatric population. Children with cancer are especially at increased risk for gastrointestinal infection-related morbidity and mortality due to their ongoing immunosuppression. However, the epidemiology of diarrheal illnesses in immunocompromised children is poorly understood. In the past, many or most cases of gastroenteritis have gone undiagnosed, largely due to a lack of sensitive diagnostic tests and a presumption that a large proportion of cases are due to treatment, rather than infections. The availability of new diagnostic tests that detect many gastrointestinal pathogens simultaneously offers the first opportunity to gain a comprehensive picture of the causes of infectious diarrhea in children with cancer. Researchers at St. Jude Children's Research Hospital want to learn about the epidemiology of diarrheal diseases in pediatric oncology patients utilizing broadly multiplexed, automated PCR.
Probiotics are commercially available live bacteria thought to have health benefits when ingested. A literature review of probiotic studies in the intensive care unit (ICU) found that in patients who receive probiotics, there is a 25% reduction in lung infection, known as ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of developing any infection in the ICU. However, the studies reviewed were small and not well done. Therefore, whether probiotics are really helpful or not is unclear. Before a large carefully performed study is done to evaluate the effects of probiotics in critically ill patients, a pilot trial was needed. The Investigators completed a multicenter pilot RCT for which the primary outcomes relate to feasibility. Feasibility goals were met. 1) Recruitment for the Pilot was achieved in 1 year; 2) Adherence to the protocol was 96%; 3) There were no cases of contamination; 4) The VAP rate was 15%. This study is very important in the ongoing search for more effective strategies to prevent serious infection during critical illness. Probiotics may be an easy-to-use, readily available, inexpensive approach to help future critically ill patients around the world.
The objective of the study is to investigate the safety of a frozen or lyophilized inoculum administered, respectively, by retention enema or capsules in patients with recurrent C. difficile associated diarrhea (RCDAD). This is a single center, randomized, parallel assignment, open label safety study conducted in subjects with RCDAD. Fifty subjects will be enrolled in the study and randomized at 1:1 ratio to receive frozen filtered intestinal bacteria via retention enema or lyophilized donor intestinal bacteria. All subjects will be followed for a total of 3 years after study completion. Donors will be enrolled and screened at the laboratory in the Center for Infectious Diseases at University of Texas School of Public Health (UT-SPH). The donors will come from a variety of places, including the UT-SPH. At least 20 donors will be screened to recruit at least 15 qualified donors. Recipients may self-refer but must have a physician who agrees to accept care of the patient following fecal microbiota transplantation (FMT). Subjects consenting to treatment at Baylor St. Luke's Medical Center (BSLMC) and the UT-SPH must be willing to self-pay for the FMT in the amount of $1,500. There will be no insurance accepted. Subjects undergoing retention enema will be treated as outpatients at either at BSLMC, Kelsey-Seybold Clinic, or at the Memorial Hermann in the Texas Medical Center. All subjects taking capsules with lyophilized intestinal bacteria will be seen at UT-SPH. Once the procedure is completed, the recipient's care will be returned to their physician. At least 75 recipients will be screened to recruit 50 qualified recipients. The primary endpoint is to evaluate the safety of FMT by rectal or oral routes with secondary endpoint related to efficacy prevention of RCDAD. In order to monitor any health effects for safety, participants will be contacted pre- and 7, 14, 30 days, then monthly basis for the first 90 days after FMT and quarterly till 3 years after FMT. The following procedures will be completed: review recipient diary with the recipient to ensure that the following information is recorded correctly and a fresh stool sample will be collected from recipient, tested for C. difficile toxins and an aliquot (2mL) stored at -80C for microbiome analysis. Recipients will be contacted by phone for their diarrhea status on monthly basis till 90 days after FMT, then on quarterly basis till 3 years after FMT.