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

NCT03801317 | Completed

• 1 other identifier: 201808199
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stunting; Environmental Enteric Dysfunction

Outcome Measures

Primary Outcomes (2)

• Intestinal permeability

  The lactulose permeability test involves drinking 20 mL of a sugar water solution and collecting urine for 4 hours thereafter

  12 weeks

• Linear growth

  Change in length expressed as anthropometric z-score from enrollment to end point

  12 weeks and 32 weeks

Secondary Outcomes (5)

• Incidence of diarrhea

  12 weeks

• Adverse effects of the bovine colostrum/ egg

  12 weeks

• 16S configuration of fecal microbiota

  12 weeks

• Stunting

  12 and 32 weeks

• Environmental enteric dysfunction

  12 weeks

Study Arms (2)

BC/ egg

EXPERIMENTAL

4.3 grams egg powder + 5.7 grams bovine colostrum

Dietary Supplement: BC/ egg; Dietary Supplement: multiple micronutrient

Control

PLACEBO COMPARATOR

15 grams corn-soya blend

Dietary Supplement: Control; Dietary Supplement: multiple micronutrient

Interventions

BC/ egg DIETARY_SUPPLEMENT

4.3 egg powder + 5.7 g bovine colostrum

BC/ egg

Control DIETARY_SUPPLEMENT

15 grams corn-soya blend

Control

multiple micronutrient DIETARY_SUPPLEMENT

multiple micronutrient sprinkle powder

BC/ egg; Control

Eligibility Criteria

• Age: 9 Months - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy Children at 9-10 months of age

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Project Peanut Butter: collaborator
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Project Peanut Butter, Malawi

Blantyre, Malawi

Location

Related Publications (15)

• 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):e20160641. doi: 10.1542/peds.2016-0641. Epub 2016 Nov 4.

  PMID: 27940670 BACKGROUND

• 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.

  PMID: 25310000 BACKGROUND

• 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.

  PMID: 24037697 BACKGROUND

• 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.

  PMID: 27956653 BACKGROUND

• 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.

  PMID: 28122695 BACKGROUND

• 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.

  PMID: 27322559 BACKGROUND

• 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.

  PMID: 27211567 BACKGROUND

• 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.

  PMID: 27281303 BACKGROUND

• 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.

  PMID: 27294788 BACKGROUND

• 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.

  PMID: 27633102 BACKGROUND

• 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.

  PMID: 24807641 BACKGROUND

• Saad K, Abo-Elela MGM, El-Baseer KAA, Ahmed AE, Ahmad FA, Tawfeek MSK, El-Houfey AA, Aboul Khair 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.

  PMID: 27631207 BACKGROUND

• 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):370. doi: 10.3390/nu9040370.

  PMID: 28397754 BACKGROUND

• 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.

  PMID: 28541500 BACKGROUND

• Bierut T, Duckworth L, Grabowsky M, Ordiz MI, Laury ML, Callaghan-Gillespie M, Maleta K, Manary MJ. The effect of bovine colostrum/egg supplementation compared with corn/soy flour in young Malawian children: a randomized, controlled clinical trial. Am J Clin Nutr. 2021 Feb 2;113(2):420-427. doi: 10.1093/ajcn/nqaa325.

  PMID: 33330913 DERIVED

MeSH Terms

Conditions

Growth Disorders

Interventions

Eggs

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

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

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 11, 2019
• Study Start: December 3, 2018
• Primary Completion: December 30, 2019
• Study Completion: May 30, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)