PRObiotics and SYNbiotics to improve gut health and growth in infants in western Kenya (PROSYNK Trial): study protocol for a 4-arm, open-label, randomised, controlled trial

Mary Iwaret Otiti*, Simon Kariuki, Duolao Wang, Lindsay J. Hall, Feiko O. Ter Kuile, Stephen Allen

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)
40 Downloads (Pure)

Abstract

Background: Malnutrition amongst under-fives remains common in resource-poor countries and is resistant to current interventions. New opportunities have emerged to target “environmental enteric dysfunction” (EED) that refers to the abnormal gut structure and function that results from colonisation of the gut with pathogenic microbes and compromises nutrition and growth in early life. Although the gut microbiome may provide a defence against ingested gut pathogens through colonisation resistance, its development is adversely affected by multiple environmental factors. Dietary supplements of pro- or synbiotics may build the resilience of the gut microbiome against these environmental factors and boost colonisation resistance. We aim to assess whether dietary supplementation of newborns in rural Kenya with pro/synbiotics prevents or ameliorates EED and improves growth.

Methods: Six hundred newborns less than 4 days old will be recruited from Homa Bay County Teaching and Referral Hospital, western Kenya. Newborns will be randomly allocated, stratified by HIV exposure, in a 1:1:1:1 ratio to one of 4 study arms to receive either of two synbiotics, a probiotic or no supplement. Supplements will be given daily for 10 days and then weekly until 6 months of age. Participants will be followed until the age of 2 years. The primary outcome is systemic inflammation at 6 months assessed by plasma alpha-1-acid glycoprotein. Secondary outcomes include biomarkers of gut health and growth, anthropometric indices, morbidity and mortality.

Discussion: As dietary supplements with pro- or synbiotics may improve gut health and can be administered in early life, our findings may inform the package of interventions to prevent malnutrition and improve growth in Africa and similar low-resource settings.

Trial registration: Pan African Clinical Trials Registry, Trial number: PACTR202003893276712. Date: 02/03/2020 https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9798

Original languageEnglish
Article number284
Number of pages15
JournalTrials
Volume23
Issue number1
Early online date11 Apr 2022
DOIs
Publication statusPublished - Dec 2022

Bibliographical note

Funding Information:
Funding to conduct the trial is provided by the Liverpool School of Tropical Medicine through a grant from the Children’s Investment Fund Foundation (CIFF). The funders had no role in the design of this trial and will not have any during the execution, analysis, interpretation of the data or decision to submit the results.

Publisher Copyright:
© 2022, The Author(s).

Keywords

  • Environmental enteric dysfunction
  • Growth
  • Gut health
  • Inflammation
  • Nutrition
  • Probiotic
  • Synbiotic

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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