The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children

Stunting Clinical Trial

Official title:

The Effect of Bovine Colostrum/ Egg Supplementation in Young Malawian Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801317
• Other study ID #: 201808199
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: September 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial will consist of adding either a supplement of 4.3g egg powder + 5.7g bovine colostrum or a control flour along with a multiple micronutrient powder to the diets of healthy Malawian children 9 months of age. This supplement provides additional essential amino acids, choline and immunoactive colostrum. Children will be receive either the supplement or control for 12 weeks. Children will have regular follow-up where anthropometry is measured. At enrollment and after 12 weeks, stool will be collected and a urinary lactulose permeability test conducted. Children will be measured at enrollment and at weeks 2, 4, 8, 12, 20, 32 after enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: May 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 10 Months

Eligibility

Inclusion Criteria:

• Healthy Children at 9-10 months of age

Exclusion Criteria:

• Malnutrition

• congenital abnormalities

• chronic diseases such as heart disease, cerebral palsy, or HIV infection

Related Conditions & MeSH terms

• Environmental Enteric Dysfunction
• Growth Disorders
• Stunting

Intervention

Dietary Supplement:
• BC/ egg
4.3 egg powder + 5.7 g bovine colostrum
• Control
15 grams corn-soya blend
• multiple micronutrient
multiple micronutrient sprinkle powder

Locations

Country	Name	City	State
Malawi	Project Peanut Butter, Malawi	Blantyre

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Project Peanut Butter, University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

References & Publications (14)

Halasa M, Maciejewska D, Baskiewicz-Halasa M, Machalinski B, Safranow K, Stachowska E. Oral Supplementation with Bovine Colostrum Decreases Intestinal Permeability and Stool Concentrations of Zonulin in Athletes. Nutrients. 2017 Apr 8;9(4). pii: E370. doi: 10.3390/nu9040370. — View Citation

Iannotti LL, Lutter CK, Bunn DA, Stewart CP. Eggs: the uncracked potential for improving maternal and young child nutrition among the world's poor. Nutr Rev. 2014 Jun;72(6):355-68. doi: 10.1111/nure.12107. Epub 2014 May 7. Review. — View Citation

McKay S, Gaudier E, Campbell DI, Prentice AM, Albers R. Environmental enteropathy: new targets for nutritional interventions. Int Health. 2010 Sep;2(3):172-80. doi: 10.1016/j.inhe.2010.07.006. — View Citation

Ordiz MI, Stephenson K, Agapova S, Wylie KM, Maleta K, Martin J, Trehan I, Tarr PI, Manary MJ. Environmental Enteric Dysfunction and the Fecal Microbiota in Malawian Children. Am J Trop Med Hyg. 2017 Feb 8;96(2):473-476. doi: 10.4269/ajtmh.16-0617. Epub 2016 Dec 12. — View Citation

Owino V, Ahmed T, Freemark M, Kelly P, Loy A, Manary M, Loechl C. Environmental Enteric Dysfunction and Growth Failure/Stunting in Global Child Health. Pediatrics. 2016 Dec;138(6). pii: e20160641. Epub 2016 Nov 4. Review. — View Citation

Prendergast AJ, Humphrey JH. The stunting syndrome in developing countries. Paediatr Int Child Health. 2014 Nov;34(4):250-65. doi: 10.1179/2046905514Y.0000000158. Epub 2014 Oct 13. Review. — View Citation

Saad K, Abo-Elela MG, El-Baseer KA, Ahmed AE, Ahmad FA, Tawfeek MS, El-Houfey AA, AboulKhair MD, Abdel-Salam AM, Abo-Elgheit A, Qubaisy H, Ali AM, Abdel-Mawgoud E. Effects of bovine colostrum on recurrent respiratory tract infections and diarrhea in children. Medicine (Baltimore). 2016 Sep;95(37):e4560. doi: 10.1097/MD.0000000000004560. — View Citation

Savarino SJ, McKenzie R, Tribble DR, Porter CK, O'Dowd A, Cantrell JA, Sincock SA, Poole ST, DeNearing B, Woods CM, Kim H, Grahek SL, Brinkley C, Crabb JH, Bourgeois AL. Prophylactic Efficacy of Hyperimmune Bovine Colostral Antiadhesin Antibodies Against Enterotoxigenic Escherichia coli Diarrhea: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Trial. J Infect Dis. 2017 Jul 1;216(1):7-13. doi: 10.1093/infdis/jix144. — View Citation

Semba RD, Gonzalez-Freire M, Moaddel R, Trehan I, Maleta KM, Khadeer M, Ordiz MI, Ferrucci L, Manary MJ. Environmental Enteric Dysfunction Is Associated With Altered Bile Acid Metabolism. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):536-540. doi: 10.1097/MPG.0000000000001313. — View Citation

Semba RD, Shardell M, Sakr Ashour FA, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Kraemer K, Khadeer MA, Ferrucci L, Manary MJ. Child Stunting is Associated with Low Circulating Essential Amino Acids. EBioMedicine. 2016 Apr;6:246-252. doi: 10.1016/j.ebiom.2016.02.030. Epub 2016 Feb 19. — View Citation

Semba RD, Shardell M, Trehan I, Moaddel R, Maleta KM, Ordiz MI, Kraemer K, Khadeer M, Ferrucci L, Manary MJ. Metabolic alterations in children with environmental enteric dysfunction. Sci Rep. 2016 Jun 13;6:28009. doi: 10.1038/srep28009. — View Citation

Semba RD, Trehan I, Gonzalez-Freire M, Kraemer K, Moaddel R, Ordiz MI, Ferrucci L, Manary MJ. Perspective: The Potential Role of Essential Amino Acids and the Mechanistic Target of Rapamycin Complex 1 (mTORC1) Pathway in the Pathogenesis of Child Stunting. Adv Nutr. 2016 Sep 15;7(5):853-65. doi: 10.3945/an.116.013276. Print 2016 Sep. — View Citation

Semba RD, Trehan I, Li X, Moaddel R, Ordiz MI, Maleta KM, Kraemer K, Shardell M, Ferrucci L, Manary M. Environmental Enteric Dysfunction is Associated with Carnitine Deficiency and Altered Fatty Acid Oxidation. EBioMedicine. 2017 Mar;17:57-66. doi: 10.1016/j.ebiom.2017.01.026. Epub 2017 Jan 18. — View Citation

Semba RD, Zhang P, Gonzalez-Freire M, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Ferrucci L, Manary MJ. The association of serum choline with linear growth failure in young children from rural Malawi. Am J Clin Nutr. 2016 Jul;104(1):191-7. doi: 10.3945/ajcn.115.129684. Epub 2016 Jun 8. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal permeability	The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter	12 weeks
Primary	Linear growth	Change in length expressed as anthropometric z-score from enrollment to end point	12 weeks and 32 weeks
Secondary	Incidence of diarrhea	Caregiver report of number of days they child has diarrhea over the course of the study	12 weeks
Secondary	Adverse effects of the bovine colostrum/ egg	Caregiver report of number of days they child has adverse effects over the course of the study	12 weeks
Secondary	16S configuration of fecal microbiota	Looking at the 16S configuration in stool samples collected	12 weeks
Secondary	Stunting	Categorization of length-for-age z-scores	12 and 32 weeks
Secondary	Environmental enteric dysfunction	Categorization of lactulose permeability measurements	12 weeks