Safety and Immunogenicity of Single Dose Choleragarde® in HIV-Seropositive Adults
CholeraVibrio Infections1 moreThe purpose of this study is to assess the safety and immunogenicity of Peru-15 (CholeraGarde®) vaccine in HIV seropositive adult population of Bangkok Thailand
Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics
Antibiotic-Associated DiarrheaProspective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.
Solar Water Disinfection Intervention Trial in Bolivia
DiarrheaThe importance of waterborne gastrointestinal illness throughout the developing world, the existence of a cheap and effective intervention (SODIS), the concurrent limited dissemination program for SODIS, the need for a controlled evaluation of the effectiveness of SODIS under actual field conditions, and the experience of our tri-national collaborative research team in successfully conducting large scale drinking water intervention and observational studies in both the United States and the developing world encourage us to propose the following randomized controlled trial in which our specific aims are to: Evaluate the hypothesis that SODIS reduces the incidence of gastrointestinal illness in 660 children under the age of five years in rural Bolivia that are randomly selected from 22 villages ; Define, through an extensive microbiologic testing component, the baseline rates of pathogen-specific diarrheal illnesses and the pathogens responsible for the differences in diarrheal illness between active and control groups; Document the actual use and acceptance of SODIS by participants in the study; Assess the cost-effectiveness of SODIS and the social and economic impact of SODIS at household level; Examine through mathematical disease modelling the effects of the presence of multiple transmission pathways within a village on the preventable fraction estimate due to the introduction of SODIS.
Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
Zinc DeficiencyDiarrhea1 moreZinc supplementation can either be provided in a lower daily dose to prevent zinc deficiency or in a higher dose for 10-14 days as part of the treatment of diarrhea. It is important to determine how best to integrate programs designed either to prevent zinc deficiency or to treat diarrhea. The overall objective of this project is to determine the most effective approach to prevent zinc deficiency and treat diarrhea, such that a single approach could provide the maximal beneficial impact on the health and nutritional status of young children and greatest simplicity of implementation.
Micronutrient Sprinkles in a Daycare Center
DiarrheaRespiratory InfectionDiarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of micronutrient deficiencies including zinc. The primary aims of the proposed study are to evaluate the effect of the use of multiple micronutrient sprinkles including zinc on compliance of supplement use and the incidence of recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23...
MorbidityMortality2 moreChildren, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.
Dose-Finding Study of WS6788A and LSN03-016011/A Enterotoxigenic E. Coli ETEC Challenge Strains...
Travelers' DiarrheaThis will be a strain and dose-finding study in which LSN03-016011/A ETEC will be administered at a starting inoculum of 5x108 cfu to 5 subjects to establish a human disease model. If 80% attack rate (AR) is achieved without high output diarrhea, the same inoculum will be given to 10 more subjects for confirmation of AR. If 80% AR is not achieved, attack rate and severity of disease will be evaluated to determine if the dose should be increased. The same sequence may be conducted with WS6788A if applicable. If the LSN strain causes high output diarrhea the dose will be adjusted down and further dose characterization continued. An iterative process will be used to select the optimal strain and dose with each step reviewed and approved by the medical monitor.
Calcium, Probiotics and Acute Diarrheal Disease Among Indonesian Children
HealthyDiarrheaThis is a long term study on the efficacy of dietary calcium with or without probiotic strains in reducing the mean number of episodes and duration of diarrheal disease.
Invaplex 50 Vaccine Dose-Ranging
DiarrheaThe vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits.
Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine
CholeraDiarrhea1 moreThe purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.