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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02231047
Recruitment Status : Unknown
Verified November 2014 by H2O Health and Agriculture LLC.
Recruitment status was:  Not yet recruiting
First Posted : September 3, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
H2O Health and Agriculture LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diarrhea Pneumonia Dietary Supplement: 64N Nutraceutical Other: No 64N Nutraceutical Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: 64N Nutraceutical for the Prevention of Childhood Diarrhea and Pneumonia in Low Resource Settings
Study Start Date : January 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Pneumonia

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 Name: 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)




Primary Outcome Measures :
  1. Mortality from childhood diarrhea and pneumonia [ Time Frame: Assessed every 3 months for 4.5 years ]

Secondary Outcome Measures :
  1. Medical visits for childhood diarrhea and pneumonia [ Time Frame: Every 3 months for 4.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231047


Contacts
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Contact: Donna M Rohrs, DHSc, PA 517.281.0344 h2ohealthag@gmail.com

Locations
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Guatemala
Santa Maria de Jesus, Sacatepequez, Guatemala, 03011
Contact: Donna M Rohrs, DHSc, PA    517.281.0344    h2ohealthag@gmail.com   
Principal Investigator: Donna M Rohrs, DHSc, PA         
Sponsors and Collaborators
H2O Health and Agriculture LLC
Investigators
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Principal Investigator: Donna M Rohrs, DHSc, PA H2O Health and Agriculture LLC

Publications:
Godhia, ML, Patel, N. Colostrum - its composition, benefits as a nutraceutical: A review. Current Research in Nutrition and Food Science, 1(1), 37-47, 2013.
World Health Organization. Causes of child mortality, by region, 2000-2011. In Global health observatory (GHO), (2014) Retrieved from http://www.who.int/gho/child_health/mortality/mortality_causes_region_text/en/
World Health Organization. Childhood vaccines at all-time high, but access not equitable, (2009). Retrieved from http://www.who.int/mediacentre/news/releases/2009/state_immunizaton_200910

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Responsible Party: H2O Health and Agriculture LLC
ClinicalTrials.gov Identifier: NCT02231047    
Other Study ID Numbers: H2O - BCO1
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by H2O Health and Agriculture LLC:
Diarrhea
Pneumonia
Child, Preschool
Infant
Dietary Supplements
Colostrums
Developing Countries
Additional relevant MeSH terms:
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Pneumonia
Diarrhea
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms