<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02231047</url>
  </required_header>
  <id_info>
    <org_study_id>H2O - BCO1</org_study_id>
    <nct_id>NCT02231047</nct_id>
  </id_info>
  <brief_title>64N Nutraceutical for the Prevention of Childhood Diarrhea and Pneumonia in Low Resource Settings</brief_title>
  <official_title>64N Nutraceutical for the Prevention of Childhood Diarrhea and Pneumonia in Low Resource Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H2O Health and Agriculture LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H2O Health and Agriculture LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the occurrence of childhood diarrheal disease and&#xD;
      pneumonia in subjects under the age of 5 years in low resource settings who have received&#xD;
      prophylactic 64N nutraceutical (64N)as a neonate as compared with neonates who have not&#xD;
      received prophylactic 64N.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diarrheal disease and pneumonia are two of the top four causes of mortality in children under&#xD;
      the age of five . In 2010, 64 percent of deaths in this age group were due to infectious&#xD;
      causes. A majority of these deaths occur in developing countries. Although vaccines have been&#xD;
      proven to prevent pneumonia and diarrheal disease due to rotavirus, these vaccines may not be&#xD;
      available to the most vulnerable children in developing countries. Barriers to vaccination in&#xD;
      the poorest countries include lack of infrastructure, poor health systems, lack of finances,&#xD;
      and lack of transportation. It has been estimated that an additional one billion US dollars&#xD;
      will be needed to guarantee that the most vulnerable populations receive vaccinations.&#xD;
&#xD;
      Diarrheal disease is especially problematic since pathogens other than rotavirus cause&#xD;
      diarrhea in children living in developing countries. Examples of pathogens causing diarrhea&#xD;
      include Vibrio cholera, Salmonella enterica serovar Typhi, Escherichia coli [E. coli],&#xD;
      Cryptosporidium, Entamoeba histolytica, and Shigella. Parasitic worms of the Schistosoma&#xD;
      genus also cause diarrheal disease in poor countries. In developing countries, infants 0 to&#xD;
      11 months of age are at the highest risk of dying from diarrhea caused by typical E. coli and&#xD;
      E. coli producing heat-stable toxin. Children 12 to 23 months of age are at the highest risk&#xD;
      of dying from diarrhea caused by Cryptosporidium. It has been recommended that five pathogens&#xD;
      (i.e., typical E. coli, E. coli producing heat-stable toxin, Cryptosporidium, Shigella,&#xD;
      rotavirus) be targeted in order to decrease the burden of moderate-to-severe childhood&#xD;
      diarrhea in developing countries.&#xD;
&#xD;
      In order to improve survival for children under the age of five in low resource settings,&#xD;
      cost-effective, patient-directed, accessible, innovative, and alternative interventions that&#xD;
      are culturally appropriate need to be explored. One such intervention that may confer passive&#xD;
      immunity to protect young children in low resource settings against the multiple pathogenic&#xD;
      causes of childhood diarrhea as well as childhood pneumonia is the utilization of 64N.&#xD;
&#xD;
      64N has been used by Ayurvedic physicians for medicinal purposes in humans in India and was&#xD;
      also commonly used in Western medicine prior to the development of penicillin and other&#xD;
      manufactured antibiotics. Both hyperimmune 64N and unadulterated 64N have been studied in&#xD;
      children. Infants fed defatted hyperimmune 64N significantly decreased diarrhea due to&#xD;
      rotavirus as compared with infants who received milk from the market. In children 3 to 15&#xD;
      months of age, 64N decreased rotavirus infection as compared with artificial infant formula.&#xD;
&#xD;
      Treatment studies have also shown a benefit of 64N for diarrhea. In children presenting with&#xD;
      diarrhea due to E. coli, administration of 64N significantly decreased stool frequency as&#xD;
      compared with placebo. 64N concentrates were found to be effective in the treatment of&#xD;
      infants with hemorrhagic diarrhea and stopped the progression of the disease to hemolytic&#xD;
      urea syndrome. 64N has also been studied in children (1 to 10 years of age) who had mild to&#xD;
      moderate nonorganic failure to thrive. In this randomized controlled trial, the authors found&#xD;
      that the Gomez index (a weight for age index) was significantly improved with 3 months of 64N&#xD;
      supplementation as compared with no 64N supplementation.&#xD;
&#xD;
      There are few side effects of 64N. These are limited to lactose intolerance and sensitivity&#xD;
      to milk proteins.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality from childhood diarrhea and pneumonia</measure>
    <time_frame>Assessed every 3 months for 4.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical visits for childhood diarrhea and pneumonia</measure>
    <time_frame>Every 3 months for 4.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Diarrhea</condition>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>64N Nutraceutical</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Powdered 64N Nutraceutical 40 mg/kg/day mixed in 12 ounces of a culturally appropriate warm drink for 1 week (7 days).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No 64N Nutraceutical</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Culturally appropriate 12 ounce warm drink daily for 1 week (7 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>64N Nutraceutical</intervention_name>
    <description>40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)</description>
    <arm_group_label>64N Nutraceutical</arm_group_label>
    <other_name>Bovine colostrum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No 64N Nutraceutical</intervention_name>
    <description>12 ounce warm drink daily for 1 week (7 days)</description>
    <arm_group_label>No 64N Nutraceutical</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy neonates&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonates with milk intolerance&#xD;
&#xD;
          -  Neonates with lactose intolerance&#xD;
&#xD;
          -  Premature neonates&#xD;
&#xD;
          -  Neonates in poor health or who are being followed by a medical provider for illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Hours</minimum_age>
    <maximum_age>1 Day</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna M Rohrs, DHSc, PA</last_name>
    <role>Principal Investigator</role>
    <affiliation>H2O Health and Agriculture LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donna M Rohrs, DHSc, PA</last_name>
    <phone>517.281.0344</phone>
    <email>h2ohealthag@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <address>
        <city>Santa Maria de Jesus</city>
        <state>Sacatepequez</state>
        <zip>03011</zip>
        <country>Guatemala</country>
      </address>
    </facility>
    <contact>
      <last_name>Donna M Rohrs, DHSc, PA</last_name>
      <phone>517.281.0344</phone>
      <email>h2ohealthag@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Donna M Rohrs, DHSc, PA</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Guatemala</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23178060</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>2570959</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>4069083</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10512407</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22254105</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23680352</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: Lancet. 2012 Oct 13;380(9850):1308.</citation>
    <PMID>22579125</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20639714</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12142957</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18952725</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18538107</PMID>
  </reference>
  <reference>
    <citation>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/</citation>
  </reference>
  <reference>
    <citation>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</citation>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>November 15, 2014</last_update_submitted>
  <last_update_submitted_qc>November 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diarrhea</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Child, Preschool</keyword>
  <keyword>Infant</keyword>
  <keyword>Dietary Supplements</keyword>
  <keyword>Colostrums</keyword>
  <keyword>Developing Countries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02231047
org study id: H2O - BCO1
nct id: NCT02231047
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Mortality from childhood diarrhea and pneumonia
time frame: Assessed every 3 months for 4.5 years
measure: Medical visits for childhood diarrhea and pneumonia
time frame: Every 3 months for 4.5 years
arm group label: 64N Nutraceutical
arm group type: Experimental
description: Powdered 64N Nutraceutical 40 mg/kg/day mixed in 12 ounces of a culturally appropriate warm drink for 1 week (7 days).
arm group label: No 64N Nutraceutical
arm group type: Sham Comparator
description: Culturally appropriate 12 ounce warm drink daily for 1 week (7 days).
intervention type: Dietary Supplement
intervention name: 64N Nutraceutical
description: 40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)
arm group label: 64N Nutraceutical
other name: Bovine colostrum
intervention type: Other
intervention name: No 64N Nutraceutical
description: 12 ounce warm drink daily for 1 week (7 days)
arm group label: No 64N Nutraceutical
criteria: 
gender: All
minimum age: 6 Hours
maximum age: 1 Day
healthy volunteers: Accepts Healthy Volunteers
last name: Donna M Rohrs, DHSc, PA
role: Principal Investigator
affiliation: H2O Health and Agriculture LLC
last name: Donna M Rohrs, DHSc, PA
phone: 517.281.0344
email: h2ohealthag@gmail.com
facility: 
contact: 
investigator: 
country: Guatemala
citation: 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.
PMID: 23178060
citation: 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.
PMID: 2570959
citation: 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.
PMID: 4069083
citation: 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.
citation: 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.
PMID: 10512407
citation: 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.
PMID: 22254105
citation: 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.
PMID: 23680352
citation: 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. Erratum In: Lancet. 2012 Oct 13;380(9850):1308.
PMID: 22579125
citation: 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.
PMID: 20639714
citation: 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.
PMID: 12142957
citation: 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.
PMID: 18952725
citation: 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.
PMID: 18538107
citation: 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/
citation: 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
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Diarrhea