Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
DiarrheaThe main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization.
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
DiarrheaAIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea. TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).
Secondary Lactose Intolerance Due to Chronic Norovirus Infection
Chronic DiarrheaThe objective of this study is to determine the prevalence of secondary lactose intolerance in renal transplant recipients (RTR) with chronic norovirus infection. In the investigators cohort of 1000 renal transplant recipients (RTRs) in the University Hospital of Zurich, the investigators are currently aware of 10 patients with chronic norovirus infection, which was proven by positive polymerase chain reaction (PCR) analysis of recent stool samples, whereas chronic virus shedding is defined as more than two PCR positive samples in an interval of at least one month. Concomitant viral (other than norovirus), bacterial or parasitic (particularly Gardia lamblia) intestinal infections are excluded by negative stool cultures and PCR analyses, respectively. Main exclusion criterion for the present case series is a concomitant intestinal infection (other than norovirus) and primary lactose intolerance, which is previously excluded by absence of the CC genotype of the DNA variant -13910 T/C upstream in the LCT gene. After obtaining written and oral informed consent, the investigators perform a lactose hydrogen breath (LH2BT) test and a lactose tolerance test (LTT) in all eligible RTRs with proven chronic norovirus infection irrespective of current abdominal symptoms. The study population (N=10) is divided into two groups according to the gastrointestinal symptoms (asymptomatic versus symptomatic, such as chronic diarrhoea or diffuse abdominal discomfort). The investigators chose the cut-off three or more stools per day as indicative of diarrhoea for the purpose of this study. RTRs with otherwise unexplainable chronic diarrhoea but absent norovirus infection serve as control group (N=10).
Evaluation of Safe-Water Programs in Baja California Sur, Mexico
DiarrheaFundacion Cantaro Azul (FCA) is a non-profit organization in Baja California Sur, Mexico (BCS). Since 2006 FCA has piloted a safe drinking-water program in rural regions of BCS. The premise of their safe drinking-water programs has been the installation of household drinking-water disinfection systems which utilize an ultra-violet technology (UV) developed at the University of California, Berkeley. While the systems have been tested for safety and effectiveness at inactivating waterborne pathogens, FCA is interested in rigorously evaluating the impact of their safe drinking-water program at the population level. FCA is looking to expand their safe-water program during 2009 and 2010 to newly identified communities that lack safe-drinking water. In order to evaluate the community level effectiveness of their program FCA has agreed to randomize the timing of this expansion which will allow the lead investigators and key personal in this protocol to conduct a meaningful, scientific evaluation of the impact of their program through a randomized stepped wedge design. The research described in this protocol has four (4) primary objectives: To evaluate the impact the implementation of the safe drinking-water programs has on rates of gastrointestinal events in rural BCS communities; To evaluate the impact of the safe drinking-water programs on concentrations of fecal contamination in household drinking-water in rural BCS communities; To evaluate other-health and non-water impacts on communities where the safe-water programs are implemented, including school and work absenteeism, and health care costs; To identify household, program and system design characteristics that affect user compliance with the disinfection strategies. The investigators hypothesize that households that receive an UV based drinking-water disinfection system through the safe-water program will have reduced prevalence of gastrointestinal illness, and reductions in fecal contamination of household drinking-water, measured as concentrations of Escherichia Coli per 100 ml of water. Similarly, the investigators hypothesize that these communities will also have reduced health care costs, and school and work absenteeism due to the implementation of the safe drinking-water programs. The investigators further hypothesize that household level characteristics and specific program characteristics will differentially impact user compliance, measured as the sustained use of the systems over the course of the study. In order to evaluate the last hypothesis (Objective 4) two program variations will be rolled out to inform future programmatic decisions. A priori the investigators do not anticipate that these program variations will impact population measures for Objectives 1 and 2, but the investigators will explore these assumptions during analysis.
Diarrhea and Bivalent Oral Polio Vaccine Immunity
SeroimmunityDiarrhea1 moreGlobal eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate eradication. One concern in this effort is that some populations have decreased immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV) was recommended for use in immunization campaigns, and will likely replace tOPV in routine immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been studied. This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who reside in Nepal. The investigators conducted a prospective, interventional study that assessed immune response to bOPV among infants with and without diarrhea. Immune responses were compared among infants with and without diarrhea. This study will result in a better understanding of the factors that decrease the ability of some children to seroconvert to OPV and be protected from poliomyelitis infection.
Cluster Randomised Trial of Improved Sanitation in Rural Orissa, India
DiarrhoeaSoil-transmitted Helminth Infection1 moreThe study is a cluster-randomized, controlled trial conducted among 100 villages (including approximately 3500 households and 20,000 people) in Puri district, State of Orissa, India. The study aims to assess the impact of the construction and use of latrines in rural settings on diarrhoeal disease, helminth infections and nutritional status. The study will also report on the cost and cost-effectiveness of the intervention and its impact on lost days at school and work as well as on expenditures on drugs and medical treatment. The study will document how the intervention actually impacts exposure to human excreta along principal transmission pathways by evaluating the impact on (i) faecal contamination of drinking water, (ii) the presence of mechanical vectors (flies) in food preparation areas, and (iii) the presence of faeces in and around participating households and villages. The study will also explore the extent to which different levels of acquisition and use of on-site sanitation among householders impact disease throughout the community.
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
DiarrhoeaThe aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
Oral Supplement for Pregnant and Lactating Mothers
DiarrheaAcute Respiratory InfectionTo assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.
Yogurt Study in Children 2-4 Years Old Attending Daycare
InfectionsRespiratory1 moreThe purpose of this study is to determine the effectiveness of probiotics (popularly referred to as 'live active culture' or 'good bacteria') in preventing illnesses and consequent absences from school/daycare centers of children two to four years old that attend daycare at least 3 days per week. Two yogurt drinks will be administered, one containing a specific strain of probiotic, Bb-12. It is hypothesized that children receiving the Bb-12 drink will experience fewer illnesses and absences from daycare. In this study, participants will be asked to: Give their child 4 oz. of the test yogurt each day for 90 days Keep a daily diary of their child's health Collect 3 stool samples from their child at the start, middle, and end of the study Speak with research personnel on a bi-weekly basis regarding their child's health Ensure that their child to consume any yogurts or probiotic-containing products for 110 days of the study
Folic Acid and Vitamin B12 in Young Indian Children
DiarrheaPneumoniaHypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea. Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.