NCT02231047

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

4.6 years

First QC Date

August 28, 2014

Last Update Submit

November 15, 2014

Conditions

DiarrheaPneumonia

Keywords

DiarrheaPneumoniaChild, PreschoolInfantDietary SupplementsColostrumsDeveloping Countries

Outcome Measures

Primary Outcomes (1)

  • Mortality from childhood diarrhea and pneumonia

    Assessed every 3 months for 4.5 years

Secondary Outcomes (1)

  • Medical visits for childhood diarrhea and pneumonia

    Every 3 months for 4.5 years

Study Arms (2)

64N Nutraceutical

EXPERIMENTAL

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

No 64N Nutraceutical

SHAM COMPARATOR

Culturally appropriate 12 ounce warm drink daily for 1 week (7 days).

Other: No 64N Nutraceutical

Interventions

64N NutraceuticalDIETARY_SUPPLEMENT

40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)

Also known as: Bovine colostrum
64N Nutraceutical
No 64N NutraceuticalOTHER

12 ounce warm drink daily for 1 week (7 days)

No 64N Nutraceutical

Eligibility Criteria

Age6 Hours - 1 Day
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy neonates

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Santa María de Jesús, Departamento de Sacatepéquez, 03011, Guatemala

Location

Related Publications (14)

  • 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: 23178060BACKGROUND

  • 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: 2570959BACKGROUND

  • 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: 4069083BACKGROUND

  • 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.

    BACKGROUND

  • 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: 10512407BACKGROUND

  • 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: 22254105BACKGROUND

  • 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: 23680352BACKGROUND

  • 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.

    PMID: 22579125BACKGROUND

  • 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: 20639714BACKGROUND

  • 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: 12142957BACKGROUND

  • 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: 18952725BACKGROUND

  • 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: 18538107BACKGROUND

  • 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/

    BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

DiarrheaPneumonia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Donna M Rohrs, DHSc, PA

    H2O Health and Agriculture LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna M Rohrs, DHSc, PA

CONTACT

517.281.0344h2ohealthag@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 3, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

GU(1)