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StuntingNCT03801317

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

A study testing BC/ egg and multiple micronutrient in people with Stunting and Environmental Enteric Dysfunction, run by Washington University School of Medicine at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 9 to 10 monthsHealthy volunteers can take part
Conditions the study is for
Stunting, Environmental Enteric Dysfunction
What is being tested?
BC/ egg and multiple micronutrient
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
278 participants
Where
1 siteMalawi
Study dates
3 Dec 2018to 30 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 10 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy Children at 9-10 months of age

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • Project Peanut Butter, Malawi

    Blantyre

Other trials in Malawi

About this study

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.

Being tested
BC/ egg, Control, multiple micronutrient
Medical subject headings
Growth Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BC/ eggDietary supplement

    4.3 egg powder + 5.7 g bovine colostrum

  • ControlDietary supplement

    15 grams corn-soya blend

  • multiple micronutrientDietary supplement

    multiple micronutrient sprinkle powder

Study groups in NCT03801317
Study groupRoleWhat they receive
BC/ eggExperimental4.3 grams egg powder + 5.7 grams bovine colostrum
Receives: Dietary Supplement: BC/ egg; Dietary Supplement: multiple micronutrient
ControlPlacebo comparator15 grams corn-soya blend
Receives: Dietary Supplement: Control; Dietary Supplement: multiple micronutrient

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intestinal permeability

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

    Measured: 12 weeks

  2. Linear growth

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

    Measured: 12 weeks and 32 weeks

Secondary outcomes (5)

  1. Incidence of diarrhea

    Caregiver report of number of days they child has diarrhea over the course of the study

    Measured: 12 weeks

  2. Adverse effects of the bovine colostrum/ egg

    Caregiver report of number of days they child has adverse effects over the course of the study

    Measured: 12 weeks

  3. 16S configuration of fecal microbiota

    Looking at the 16S configuration in stool samples collected

    Measured: 12 weeks

  4. Stunting

    Categorization of length-for-age z-scores

    Measured: 12 and 32 weeks

  5. Environmental enteric dysfunction

    Categorization of lactulose permeability measurements

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2019
  2. Study start3 Dec 2018
  3. Primary completion30 Dec 2019
  4. Study completion30 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03801317
Sponsor's protocol ID
201808199
Status last verified
Sep 2020
First submitted
10 Jan 2019
Last updated
16 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27940670

  • 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.

    PubMed 25310000

  • 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.

    PubMed 24037697

  • 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.

    PubMed 27956653

  • 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.

    PubMed 28122695

  • 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.

    PubMed 27322559

  • 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.

    PubMed 27211567

  • 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.

    PubMed 27281303

  • 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.

    PubMed 27294788

  • 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.

    PubMed 27633102

  • 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.

    PubMed 24807641

  • 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.

    PubMed 27631207

  • 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.

    PubMed 28397754

  • 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.

    PubMed 28541500

  • 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.

    PubMed 33330913

Questions about this trial

What is this clinical trial studying?

A study testing BC/ egg and multiple micronutrient in people with Stunting and Environmental Enteric Dysfunction, run by Washington University School of Medicine at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intestinal permeability (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03801317, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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