64N Nutraceutical for the Prevention of Childhood Diarrhea and Pneumonia in Low Resource Settings
NCT ID: NCT02231047
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2015-01-31
2019-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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64N Nutraceutical
Powdered 64N Nutraceutical 40 mg/kg/day mixed in 12 ounces of a culturally appropriate warm drink for 1 week (7 days).
64N Nutraceutical
40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)
No 64N Nutraceutical
Culturally appropriate 12 ounce warm drink daily for 1 week (7 days).
No 64N Nutraceutical
12 ounce warm drink daily for 1 week (7 days)
Interventions
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64N Nutraceutical
40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)
No 64N Nutraceutical
12 ounce warm drink daily for 1 week (7 days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Neonates with lactose intolerance
* Premature neonates
* Neonates in poor health or who are being followed by a medical provider for illness
6 Hours
1 Day
ALL
Yes
Sponsors
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H2O Health and Agriculture LLC
OTHER
Responsible Party
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Principal Investigators
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Donna M Rohrs, DHSc, PA
Role: PRINCIPAL_INVESTIGATOR
H2O Health and Agriculture LLC
Locations
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Santa María de Jesús, Departamento de Sacatepéquez, Guatemala
Countries
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Central Contacts
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Facility Contacts
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References
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Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am. 2013 Feb;60(1):49-74. doi: 10.1016/j.pcl.2012.10.002.
Davidson GP, Whyte PB, Daniels E, Franklin K, Nunan H, McCloud PI, Moore AG, Moore DJ. Passive immunisation of children with bovine colostrum containing antibodies to human rotavirus. Lancet. 1989 Sep 23;2(8665):709-12. doi: 10.1016/s0140-6736(89)90771-x.
Ebina T, Sato A, Umezu K, Ishida N, Ohyama S, Oizumi A, Aikawa K, Katagiri S, Katsushima N, Imai A, et al. Prevention of rotavirus infection by oral administration of cow colostrum containing antihumanrotavirus antibody. Med Microbiol Immunol. 1985;174(4):177-85. doi: 10.1007/BF02123694.
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.
Huppertz HI, Rutkowski S, Busch DH, Eisebit R, Lissner R, Karch H. Bovine colostrum ameliorates diarrhea in infection with diarrheagenic Escherichia coli, shiga toxin-producing E. Coli, and E. coli expressing intimin and hemolysin. J Pediatr Gastroenterol Nutr. 1999 Oct;29(4):452-6. doi: 10.1097/00005176-199910000-00015.
Hurley WL, Theil PK. Perspectives on immunoglobulins in colostrum and milk. Nutrients. 2011 Apr;3(4):442-74. doi: 10.3390/nu3040442. Epub 2011 Apr 14.
Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.
Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
Panahi Y, Falahi G, Falahpour M, Moharamzad Y, Khorasgani MR, Beiraghdar F, Naghizadeh MM. Bovine colostrum in the management of nonorganic failure to thrive: a randomized clinical trial. J Pediatr Gastroenterol Nutr. 2010 May;50(5):551-4. doi: 10.1097/MPG.0b013e3181b91307.
Solomons NW. Modulation of the immune system and the response against pathogens with bovine colostrum concentrates. Eur J Clin Nutr. 2002 Aug;56 Suppl 3:S24-8. doi: 10.1038/sj.ejcn.1601480.
Stelwagen K, Carpenter E, Haigh B, Hodgkinson A, Wheeler TT. Immune components of bovine colostrum and milk. J Anim Sci. 2009 Apr;87(13 Suppl):3-9. doi: 10.2527/jas.2008-1377. Epub 2008 Oct 24.
Struff WG, Sprotte G. Bovine colostrum as a biologic in clinical medicine: a review--Part II: clinical studies. Int J Clin Pharmacol Ther. 2008 May;46(5):211-25. doi: 10.5414/cpp46211.
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
Other Identifiers
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H2O - BCO1
Identifier Type: -
Identifier Source: org_study_id