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Trial record 62 of 356 for:    Recruiting, Not yet recruiting, Available Studies | "nutrition disorders" | Child

Protein Plus: Improving Infant Growth Through Diet and Enteric Health (JiVitA-6)

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ClinicalTrials.gov Identifier: NCT03683667
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief 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.

Condition or disease Intervention/treatment Phase
Stunting Malnutrition; Protein Enteric Pathogens Campylobacter Infections Drug: Azithromycin Oral Product Drug: Placebos Dietary Supplement: Protein Supplement Dietary Supplement: Isocaloric Supplement Dietary Supplement: Egg Behavioral: Nutrition Education Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3180 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: For this 2 x 4 factorial, cluster-randomized trial, 566 previously defined clusters will be assigned independently to 8 different combinations of interventions: 1) azithromycin and protein supplementation; 2) azithromycin and isocaloric supplementation; 3) azithromycin and egg; 4) azithromycin and control (nutrition education); 5) placebo and protein supplementation; 6) placebo and isocaloric supplementation; 7) placebo and egg; 8) placebo and control (nutrition education).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Efficacy of Supplemental Protein, Delivered Alone or in Combination With Treatment for Enteric Pathogens, to Prevent Growth Faltering in Bangladeshi Infants
Actual Study Start Date : September 23, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Placebo Comparator: Placebo & Control
Placebo / Nutrition education
Drug: Placebos
Contain inert excipients only

Behavioral: Nutrition Education
Monthly messaging on infant and young child feeding

Experimental: Placebo & Protein Supplement
Placebo / Protein-rich blended food / Nutrition education
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

Behavioral: Nutrition Education
Monthly messaging on infant and young child feeding

Placebo Comparator: Placebo & Isocaloric Supplement
Placebo / Isocaloric blended food / Nutrition education
Drug: Placebos
Contain inert excipients only

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

Behavioral: Nutrition Education
Monthly messaging on infant and young child feeding

Experimental: Placebo & Egg
Placebo / Egg / Nutrition education
Drug: Placebos
Contain inert excipients only

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

Experimental: Azithromycin & Control
Azithromycin / Nutrition education
Drug: Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
Other Name: Azithrocin

Behavioral: Nutrition Education
Monthly messaging on infant and young child feeding

Experimental: Azithromycin & Protein Supplement
Azithromycin / Protein-rich blended food / Nutrition education
Drug: Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
Other Name: Azithrocin

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

Behavioral: Nutrition Education
Monthly messaging on infant and young child feeding

Experimental: Azithromycin & Isocaloric Supplement
Azithromycin Isocaloric blended food Nutrition education
Drug: Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
Other Name: Azithrocin

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

Behavioral: Nutrition Education
Monthly messaging on infant and young child feeding

Experimental: Azithromycin and Egg
Azithromycin Egg Nutrition education
Drug: Azithromycin Oral Product
Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
Other Name: Azithrocin

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




Primary Outcome Measures :
  1. Length-for-age Z-score (LAZ) at 12 months of age [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683667


Contacts
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Contact: Amanda C Palmer, PhD 443-287-5050 acpalmer@jhu.edu
Contact: Alain B Labrique, PhD 443-287-4744 alabriqu@gmail.com

Locations
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Bangladesh
JiVitA Maternal and Child & Nutrition Research Site Recruiting
Gaibandha, Bangladesh
Contact: Hasmot Ali, MPH    +8801713163461    hasmot.jivita@gmail.com   
Contact: Saijuddin Shaikh, PhD    +8801713202561    saiju.jivita@gmail.com   
Principal Investigator: Alain B Labrique, PhD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
International Centre for Diarrhoeal Disease Research, Bangladesh
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Amanda C Palmer, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Md Iqbal Hossain, PhD International Centre for Diarrhoel Disease Research, Bangladesh

Publications:
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03683667     History of Changes
Other Study ID Numbers: 00008000
OPP1163259 ( Other Grant/Funding Number: Bill and Melinda Gates Foundation )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
linear growth
infant feeding
environmental enteric dysfunction

Additional relevant MeSH terms:
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Campylobacter Infections
Malnutrition
Kwashiorkor
Nutrition Disorders
Gram-Negative Bacterial Infections
Bacterial Infections
Severe Acute Malnutrition
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents