Protein Plus: Improving Infant Growth Through Diet and Enteric Health
NCT ID: NCT03683667
Last Updated: 2022-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
5283 participants
INTERVENTIONAL
2018-09-23
2020-03-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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Placebo & Control
Placebo / Nutrition education
Placebos
Contain inert excipients only
Nutrition Education
Monthly messaging on infant and young child feeding
Placebo & Protein Supplement
Placebo / Protein-rich blended food / Nutrition education
Placebos
Contain inert excipients only
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
Nutrition Education
Monthly messaging on infant and young child feeding
Placebo & Isocaloric Supplement
Placebo / Isocaloric blended food / Nutrition education
Placebos
Contain inert excipients only
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
Nutrition Education
Monthly messaging on infant and young child feeding
Placebo & Egg
Placebo / Egg / Nutrition education
Placebos
Contain inert excipients only
Egg
Egg provided daily to infants from 6-12 months of age
Nutrition Education
Monthly messaging on infant and young child feeding
Azithromycin & Control
Azithromycin / Nutrition education
Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
Nutrition Education
Monthly messaging on infant and young child feeding
Azithromycin & Protein Supplement
Azithromycin / Protein-rich blended food / Nutrition education
Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
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
Nutrition Education
Monthly messaging on infant and young child feeding
Azithromycin & Isocaloric Supplement
Azithromycin Isocaloric blended food Nutrition education
Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
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
Nutrition Education
Monthly messaging on infant and young child feeding
Azithromycin and Egg
Azithromycin Egg Nutrition education
Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
Egg
Egg provided daily to infants from 6-12 months of age
Nutrition Education
Monthly messaging on infant and young child feeding
Interventions
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Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
Placebos
Contain inert excipients only
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
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
Egg
Egg provided daily to infants from 6-12 months of age
Nutrition Education
Monthly messaging on infant and young child feeding
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
6 Months
ALL
No
Sponsors
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International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Bill and Melinda Gates Foundation
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Amanda C Palmer, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Md Iqbal Hossain, PhD
Role: PRINCIPAL_INVESTIGATOR
International Centre for Diarrhoel Disease Research, Bangladesh
Locations
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JiVitA Maternal and Child & Nutrition Research Site
Gaibandha, , Bangladesh
Countries
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References
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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.
Uauy R. Keynote: rethinking protein. Food Nutr Bull. 2013 Jun;34(2):228-31. doi: 10.1177/156482651303400213. No abstract available.
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.
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.
Other Identifiers
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OPP1163259
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
00008000
Identifier Type: -
Identifier Source: org_study_id
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