Protein Plus: Improving Infant Growth Through Diet and Enteric Health

Summary

This cluster-randomized controlled trial is designed to address linear growth faltering in 6-12-mo-old Bangladesh infants through a proof-of-concept package of interventions to a) increase intake of high quality protein and b) control enteric pathogens.

Timeline

Start

2018-09-23

Primary completion

2020-03-19

Completion

2020-03-24

Outcome

Missed primary endpoint

paper The intervention did not have a statistically significant effect on mean LAZ (β: 0.05, 95% confidence interval [CI]: -0.01, 0.10) or stunting prevalence PMID 38759886 ↗

paper provided with or without presumptive treatment for enteric pathogens, did not improve linear growth from 6 to 12 mo of age. PMID 39788294 ↗

Publications

• Background Arsenault JE, Brown KH. Dietary Protein Intake in Young Children in Selected Low-Income Countries Is Generally Adequate in Relation to Estimated Requirements for Healthy Children, Except When Complementary Food Intake Is Low. J Nutr. 2017 May;147(5):932-939. doi: 10.3945/jn.116.239657. Epub 2017 Feb 15.
• Background Uauy R. Keynote: rethinking protein. Food Nutr Bull. 2013 Jun;34(2):228-31. doi: 10.1177/156482651303400213. No abstract available.
• Background Lang D; MAL-ED Network Investigators. Opportunities to assess factors contributing to the development of the intestinal microbiota in infants living in developing countries. Microb Ecol Health Dis. 2015 May 29;26:28316. doi: 10.3402/mehd.v26.28316. eCollection 2015.
• Background MAL-ED Network Investigators. Relationship between growth and illness, enteropathogens and dietary intakes in the first 2 years of life: findings from the MAL-ED birth cohort study. BMJ Glob Health. 2017 Dec 28;2(4):e000370. doi: 10.1136/bmjgh-2017-000370. eCollection 2017.
• Palmer AC, Hossain MI, Ali H, Ayesha K, Shaikh S, Islam MT, Johura FT, Pasqualino MM, Rahman H, Haque R, Alland K, Wu LS, Schulze KJ, Chakraborty S, West KP Jr, Alam M, Ahmed T, Labrique AB. Protein supplementation delivered alone or in combination with presumptive azithromycin treatment for enteric pathogens did not improve linear growth in Bangladeshi infants: results of a cluster-randomized controlled trial. Am J Clin Nutr. 2025 Mar;121(3):597-609. doi: 10.1016/j.ajcnut.2024.12.027. Epub 2025 Jan 7.
• Pasqualino MM, Shaikh S, Hossain MI, Islam MT, Ali H, Haque R, Ayesha K, Wu LS, Dyer B, Hasan K, Alland K, Schulze KJ, Johura FT, Alam M, West KP Jr, Ahmed T, Labrique AB, Palmer AC. An Egg Intervention Improves Ponderal But Not Linear Growth Among Infants 6-12 mo of Age in Rural Bangladesh. J Nutr. 2024 Jul;154(7):2290-2299. doi: 10.1016/j.tjnut.2024.05.006. Epub 2024 May 15.
• Tong H, Thorne-Lyman A, Palmer AC, Shaikh S, Ali H, Gao Y, Pasqualino MM, Wu L, Alland K, Schulze K, West KP Jr, Hossain MI, Labrique AB. Prelacteal feeding is not associated with infant size at 3 months in rural Bangladesh: a prospective cohort study. Int Breastfeed J. 2024 Feb 27;19(1):15. doi: 10.1186/s13006-024-00621-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azithromycin	Small molecule	10 mg/kg	Oral

Indications