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临床试验/NCT03683667
NCT03683667已完成2 期

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

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 5,283 人开始时间: 2018年9月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
5,283
试验地点
1
主要终点
Length-for-age Z-score (LAZ) at 12 months of age

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Participants, care providers, investigators and outcomes assessors will be blinded to the azithromycin or placebo interventions. Neither participants nor outcomes assessors will be masked to the nutrition interventions. Investigators will be masked to the nutrition interventions.

入排标准

年龄范围
3 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Placebo & Control

Placebo Comparator

Placebo / Nutrition education

干预措施: Placebos (Drug)

Placebo & Control

Placebo Comparator

Placebo / Nutrition education

干预措施: Nutrition Education (Behavioral)

Placebo & Protein Supplement

Experimental

Placebo / Protein-rich blended food / Nutrition education

干预措施: Placebos (Drug)

Placebo & Protein Supplement

Experimental

Placebo / Protein-rich blended food / Nutrition education

干预措施: Protein Supplement (Dietary Supplement)

Placebo & Protein Supplement

Experimental

Placebo / Protein-rich blended food / Nutrition education

干预措施: Nutrition Education (Behavioral)

Placebo & Isocaloric Supplement

Placebo Comparator

Placebo / Isocaloric blended food / Nutrition education

干预措施: Placebos (Drug)

Placebo & Isocaloric Supplement

Placebo Comparator

Placebo / Isocaloric blended food / Nutrition education

干预措施: Isocaloric Supplement (Dietary Supplement)

Placebo & Isocaloric Supplement

Placebo Comparator

Placebo / Isocaloric blended food / Nutrition education

干预措施: Nutrition Education (Behavioral)

Placebo & Egg

Experimental

Placebo / Egg / Nutrition education

干预措施: Placebos (Drug)

Placebo & Egg

Experimental

Placebo / Egg / Nutrition education

干预措施: Egg (Dietary Supplement)

Placebo & Egg

Experimental

Placebo / Egg / Nutrition education

干预措施: Nutrition Education (Behavioral)

Azithromycin & Control

Experimental

Azithromycin / Nutrition education

干预措施: Azithromycin Oral Product (Drug)

Azithromycin & Control

Experimental

Azithromycin / Nutrition education

干预措施: Nutrition Education (Behavioral)

Azithromycin & Protein Supplement

Experimental

Azithromycin / Protein-rich blended food / Nutrition education

干预措施: Azithromycin Oral Product (Drug)

Azithromycin & Protein Supplement

Experimental

Azithromycin / Protein-rich blended food / Nutrition education

干预措施: Protein Supplement (Dietary Supplement)

Azithromycin & Protein Supplement

Experimental

Azithromycin / Protein-rich blended food / Nutrition education

干预措施: Nutrition Education (Behavioral)

Azithromycin & Isocaloric Supplement

Experimental

Azithromycin Isocaloric blended food Nutrition education

干预措施: Azithromycin Oral Product (Drug)

Azithromycin & Isocaloric Supplement

Experimental

Azithromycin Isocaloric blended food Nutrition education

干预措施: Isocaloric Supplement (Dietary Supplement)

Azithromycin & Isocaloric Supplement

Experimental

Azithromycin Isocaloric blended food Nutrition education

干预措施: Nutrition Education (Behavioral)

Azithromycin and Egg

Experimental

Azithromycin Egg Nutrition education

干预措施: Azithromycin Oral Product (Drug)

Azithromycin and Egg

Experimental

Azithromycin Egg Nutrition education

干预措施: Egg (Dietary Supplement)

Azithromycin and Egg

Experimental

Azithromycin Egg Nutrition education

干预措施: Nutrition Education (Behavioral)

结局指标

主要结局

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

时间窗: 12 months

次要结局

  • Body composition(6, 9, 12, 15, and 18 months)
  • Antibiotic resistance(6, 9, 12, 15, and 18 months)
  • Growth hormone and stress axes biomarkers(6 and 12 months)
  • Nutrient biomarkers(6 and 12 months)
  • Gut microbiota composition(6, 6.5, 9, 9.5, 12, 15, and 18 months)
  • Enteropathogen burden(6, 6.5, 9, 9.5, 12, 15, and 18 months)
  • Inflammatory biomarkers(6 and 12 months)
  • Environmental enteric dysfunction biomarkers(6 and 12 months)
  • Bone biomarkers(6 and 12 months)
  • Morbidity incidence(6-12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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