Skip to main content
OpenTrials
Completed

NCT Number: NCT03683667

Protein Plus: Improving Infant Growth Through Diet and Enteric Health

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Stunting a major public health problem in Bangladesh, where 36% of children under the age of five are too short for their age. While dietary data indicate that protein intakes of infants and young children are largely in line with requirements, the extent to which requirements derived for healthy infants and young children are relevant in the context of frequent infections remains an important research question.

Recent investigations indicate widespread pathogen carriage among Bangladeshi infants, with virtually all having at least one detectable pathogen in nondiarrheal stools by six months of age. Campylobacter and pathogenic E. Coli predominate in this setting. Enteric pathogens can compete with the host for available nutrients or alter nutrient metabolism. Acting via environmental enteric dysfunction, they can alter both digestion-through loss of digestive enzymes-and absorption of nutrients. Microbial translocation may further alter specific amino acid requirements.

Even in the absence of acute diarrheal disease, enteric pathogen carriage is strongly associated with linear growth faltering. Combining the effects of high pathogen burden and poor diet, as indicated by low energy and protein from complementary foods, observational evidence suggests that the potentially preventable length-for-age Z-score deficit may be as high as 0.98.

The present trial will test the combination of a) protein supplementation in the form of a protein-rich blended food or an egg, both fed daily to infants 6-12 months of age, and b) azithromycin treatment for enteric pathogens. The primary outcome will be change in length-for-age Z-score from the 6 to 12 months. Biochemical, microbiological and clinical intermediates will be measured to inform our secondary aims.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born to women enrolled in ongoing community trial (NCT02909179) over a one-year period

Exclusion criteria

  • Born to women not registered as part of the ongoing community trial (NCT02909179)

Treatment and study plan

Azithromycin Oral Product

Drug

Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age

Other names: Azithrocin

Placebos

Drug

Contain inert excipients only

Protein Supplement

Dietary Supplement

Blended food providing 125 kcal and 10 g protein as egg white powder prepared as porridge and fed daily to infants from 6-12 months of age

Isocaloric Supplement

Dietary Supplement

Blended food providing 125 kcal and 1 g protein as rice powder prepared as porridge and fed daily to infants from 6-12 months of age

Egg

Dietary Supplement

Egg provided daily to infants from 6-12 months of age

Nutrition Education

Behavioral

Monthly messaging on infant and young child feeding

Primary outcomes

  1. Length-for-age Z-score (LAZ) at 12 months of age

    Time frame: 12 months

Secondary outcomes

  1. Nutrient biomarkers

    Time frame: 6 and 12 months

    Serum essential, conditionally essential amino acids and choline (by metabolomic analysis); retinol and tocopherols (HPLC); vitamin B12 (microbiological assay); zinc (AAS); ferritin and thyroglobulin (ELISA)

  2. Growth hormone and stress axes biomarkers

    Time frame: 6 and 12 months

    Serum insulin-like growth factor 1 (IGF-1), IGF binding protein 3, cortisol, by ELISA

  3. Enteropathogen burden

    Time frame: 6, 6.5, 9, 9.5, 12, 15, and 18 months

    Campylobacter, enterotoxigenic Escherichia coli (ETEC), enteroaggregative Escherichia coli (EAEC), enteropathogenic Escherichia coli (EPEC), Shigella and Cryptosporidium, by quantitative polymerase chain reaction (qPCR)

  4. Gut microbiota composition

    Time frame: 6, 6.5, 9, 9.5, 12, 15, and 18 months

    Microbial diversity and abundance, by 16S ribosomal RNA sequencing

  5. Environmental enteric dysfunction biomarkers

    Time frame: 6 and 12 months

    Stool myeloperoxidase and intestinal fatty acid-binding protein concentrations and plasma Endogenous endotoxin-core antibody (EndoCAb), by ELISA

  6. Inflammatory biomarkers

    Time frame: 6 and 12 months

    Plasma alpha-1 acid glycoprotein, C-reactive protein and interleukin-6, by ELISA; stool inflammatory cytokines, by ELISA

  7. Bone biomarkers

    Time frame: 6 and 12 months

    Plasma collagen type X and N-Terminal Pro-C-Type Natriuretic Peptide (NT-ProCNP), by ELISA

  8. Morbidity incidence

    Time frame: 6-12 months

    Incident diarrhea/dysentery or respiratory infection, based on weekly recalls

  9. Body composition

    Time frame: 6, 9, 12, 15, and 18 months

    Fat mass by bioelectrical impedence

  10. Antibiotic resistance

    Time frame: 6, 9, 12, 15, and 18 months

    Resistance of commensal E. coli (stool) or S. pneumoniae (nasopharyngeal swab) to panel of antibiotics, by culture

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study title

Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants

Acronym: JiVitA-6

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.