Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Zinc Supplementation on the Immune and Inflammatory Responses of Children to Shigella Flexneri Infection, and Correlation With Clinical Severity of Illness and Growth Following recoveryEffect of Zinc Supplementation on the Immune and Inflammatory Responses of Children to Shigella Flexneri Infection, and Correlation With Clinical Severity of Illness and Growth Following Recovery
Brief Summary: Shigellosis is a major cause of morbidity and mortality in young children in Bangladesh and other developing countries. Further, the increasing emergence of resistance to a wide range of antibiotics is of great concern. Another major public health problem in Bangladesh is malnutrition, which is closely linked with shigellosis and with a high mortality. In Shigellosis, a heavy nutritional burden is placed on children and vital micronutrients such as vitamin A is lost in the urine. We recently found that the immune response in S. Flexneri infection was lower in children who were severely malnourished (weight-for-age≤65% as a percentage of the National Centre for Health Statistics median) when compared to children with weight-for-age from \>65-75%. T cell responses were primarily affected with lowered CD4/CD8 ratios, lowered proliferative responses to T cell mitogens, Conconavalin A (ConA) and phytohaemagglutinin (PHA). However, proliferation of pheripheral blood mononuclear cells (PBMs) was lowered only in the presence of autologous plasma suggesting that a factor(s) in plasma, probably nutritional, rather than a defect in cells themselves was responsible. In children with S. dysenteriae 1 infection, proliferative responses to PHA were similarly lowered in the presence of autologous plasma but inhibition correlated to lowered transferring levels in plasma and not to the weight-for-age of the children. Also severely malnourished children with either S. flexneri or S. dysenteriae 1 infection were more severely ill. These findingings show that immunity in malnourishrd children with shigella infection is impaired which may lead to more severe illness. As zinc has profound effects on immunity as well as clinical outcome in diarrhoeal diseases, it is possible that zinc deficiency may be a factor in reducing immunity and increasing severity of acute illness in malnourished children with shigellosis. In this study, we will investigate the effect of zinc supplementation, in a double blind placebo controlled trial, on inflammatory responses, outcome of acute illness and growth following recovery from acute illness with S. flexneri infection.


Options:
A: Inclusion Criteria:

* Children aged between 3-14 years hospitalized at ICDDR, B presenting with cholera within 24 hours of onset.
* Stool output more than 4ml/kg/hour within the first 6 hours of observation period.
* Positive dark field examination

Exclusion Criteria:

* Unable to rehydrate within 6 hours
* Negative dark field examination
* Systemic illness requiring immediate administration of antibiotics.
* Received antibiotics in the 24 hours prior to hospitalization
* Patients presenting with bloody mucoid diarrhea
* Unconscious or medical emergencies
B: Inclusion Criteria:

4-6 months of age (stratified by HIV status) Infant able to take oral preparations Consent of parent/guardian HIV status obtained from mother and child

Exclusion Criteria:

Documented micronutrient supplementation other than vitamin A in the preceding month Less than 60% of mean weight for age by NCHS guidelines (micronutrient intervention obligatory according to WHO guidelines for management of severely malnourished children) Persistent diarrhea (\>=7 days) at the time of study enrollment Exclusive breastfeeding Infants in whom a second confirmatory HIV test cannot be obtained (when required) Co-enrollment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials
C: Inclusion Criteria:

1. Age between 12-59 months
2. Moderate malnutrition (61-75% Weight / Age - NCHS Median)
3. Duration of diarrhoea of 5 days
4. Culture confirmed shigella spp in stool on enrolment

Exclusion Criteria:

1. Measles infection in the past six months
2. Presence of obvious systemic illnesses
3. Severe malnutrition
4. Residence in a location requiring a journey of\>2 hour from the Dhaka Hospital of the ICDDR,B
5. Refusal to give consent
D: Inclusion Criteria:

* Children from 2 to 59 months of age with severe pneumonia admitted to the Children´s Hospital, whose parents are willing to provide written informed consent will be eligible for participation

Exclusion Criteria:

* Children suffering from marasmus or kwashiorkor, measles, pneumonia due to aspiration of a foreign body, hepatic or renal disease, sepsis, congenital abnormalities (cardiac, renal, or genetic), complicated pneumonia (lung abscess, pleural effusion, pneumatocele, atelectasis), or severe anemia (hemoglobin less than 8 g/dL \[this cut-off is based on clinical experience with severe anemia at high altitude\])
* Children whose parents refuse to provide written informed consent.

Answer: C