64N Nutraceutical for the Prevention of Childhood Diarrhea and Pneumonia in Low Resource Settings

Study Overview
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Brief Summary
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The purpose of this study is to compare the occurrence of childhood diarrheal disease and pneumonia in subjects under the age of 5 years in low resource settings who have received prophylactic 64N nutraceutical (64N)as a neonate as compared with neonates who have not received prophylactic 64N.

Detailed Description
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Diarrheal disease and pneumonia are two of the top four causes of mortality in children under the age of five . In 2010, 64 percent of deaths in this age group were due to infectious causes. A majority of these deaths occur in developing countries. Although vaccines have been proven to prevent pneumonia and diarrheal disease due to rotavirus, these vaccines may not be available to the most vulnerable children in developing countries. Barriers to vaccination in the poorest countries include lack of infrastructure, poor health systems, lack of finances, and lack of transportation. It has been estimated that an additional one billion US dollars will be needed to guarantee that the most vulnerable populations receive vaccinations. Diarrheal disease is especially problematic since pathogens other than rotavirus cause diarrhea in children living in developing countries. Examples of pathogens causing diarrhea include Vibrio cholera, Salmonella enterica serovar Typhi, Escherichia coli [E. coli], Cryptosporidium, Entamoeba histolytica, and Shigella. Parasitic worms of the Schistosoma genus also cause diarrheal disease in poor countries. In developing countries, infants 0 to 11 months of age are at the highest risk of dying from diarrhea caused by typical E. coli and E. coli producing heat-stable toxin. Children 12 to 23 months of age are at the highest risk of dying from diarrhea caused by Cryptosporidium. It has been recommended that five pathogens (i.e., typical E. coli, E. coli producing heat-stable toxin, Cryptosporidium, Shigella, rotavirus) be targeted in order to decrease the burden of moderate-to-severe childhood diarrhea in developing countries. In order to improve survival for children under the age of five in low resource settings, cost-effective, patient-directed, accessible, innovative, and alternative interventions that are culturally appropriate need to be explored. One such intervention that may confer passive immunity to protect young children in low resource settings against the multiple pathogenic causes of childhood diarrhea as well as childhood pneumonia is the utilization of 64N. 64N has been used by Ayurvedic physicians for medicinal purposes in humans in India and was also commonly used in Western medicine prior to the development of penicillin and other manufactured antibiotics. Both hyperimmune 64N and unadulterated 64N have been studied in children. Infants fed defatted hyperimmune 64N significantly decreased diarrhea due to rotavirus as compared with infants who received milk from the market. In children 3 to 15 months of age, 64N decreased rotavirus infection as compared with artificial infant formula. Treatment studies have also shown a benefit of 64N for diarrhea. In children presenting with diarrhea due to E. coli, administration of 64N significantly decreased stool frequency as compared with placebo. 64N concentrates were found to be effective in the treatment of infants with hemorrhagic diarrhea and stopped the progression of the disease to hemolytic urea syndrome. 64N has also been studied in children (1 to 10 years of age) who had mild to moderate nonorganic failure to thrive. In this randomized controlled trial, the authors found that the Gomez index (a weight for age index) was significantly improved with 3 months of 64N supplementation as compared with no 64N supplementation. There are few side effects of 64N. These are limited to lactose intolerance and sensitivity to milk proteins.

Official Title
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64N Nutraceutical for the Prevention of Childhood Diarrhea and Pneumonia in Low Resource Settings

Conditions
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Diarrhea, Pneumonia

Intervention / Treatment
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* Dietary Supplement: 64N Nutraceutical
* Other: No 64N Nutraceutical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy neonates Exclusion Criteria: Neonates with milk intolerance Neonates with lactose intolerance Premature neonates Neonates in poor health or who are being followed by a medical provider for illness

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64N Nutraceutical<br>Powdered 64N Nutraceutical 40 mg/kg/day mixed in 12 ounces of a culturally appropriate warm drink for 1 week (7 days). | Dietary Supplement: 64N Nutraceutical<br>* 40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)<br>* Other names: Bovine colostrum;|
| Sham Comparator: No 64N Nutraceutical<br>Culturally appropriate 12 ounce warm drink daily for 1 week (7 days). | Other: No 64N Nutraceutical<br>* 12 ounce warm drink daily for 1 week (7 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality from childhood diarrhea and pneumonia |  | Assessed every 3 months for 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical visits for childhood diarrhea and pneumonia |  | Every 3 months for 4.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea, Pneumonia, Child, Preschool, Infant, Dietary Supplements, Colostrums, Developing Countries