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

November 15, 2014 updated by: H2O Health and Agriculture LLC
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
    • Sacatepequez
      • Santa Maria de Jesus, Sacatepequez, Guatemala, 03011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 hours to 1 day (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 64N Nutraceutical
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
40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)
Other Names:
  • Bovine colostrum
SHAM_COMPARATOR: No 64N Nutraceutical
Culturally appropriate 12 ounce warm drink daily for 1 week (7 days).
Other: No 64N Nutraceutical
12 ounce warm drink daily for 1 week (7 days)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H2O Health and Agriculture LLC

Investigators

  • Principal Investigator: Donna M Rohrs, DHSc, PA, H2O Health and Agriculture LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (ESTIMATE)

September 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 15, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2O - BCO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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