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.

Conditions

• Stunting
• Malnutrition; Protein
• Enteric Pathogens
• Campylobacter Infections

Interventions

DRUG

Azithromycin Oral Product

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

DRUG

Placebos

Contain inert excipients only

DIETARY_SUPPLEMENT

Protein 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

DIETARY_SUPPLEMENT

Isocaloric 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

DIETARY_SUPPLEMENT

Egg

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

BEHAVIORAL

Nutrition Education

Monthly messaging on infant and young child feeding

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Amanda C Palmer, PhD · Johns Hopkins Bloomberg School of Public Health

• Md Iqbal Hossain, PhD · International Centre for Diarrhoel Disease Research, Bangladesh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

3 Months

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-23

Primary Completion

2020-03-19

Completion

2020-03-24

Countries

• Bangladesh

Study Locations