Efficacy of Bifidus DR10 and Oligo Saccharides / Micronutrient Fortification of Milk

Study Overview
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Brief Summary
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The purpose of the study is to evaluate effect or fortifying milk with pre and probiotics or with micronutrients on prevention of diarrhea, pneumonia and other childhood illnesses and improvement in growth and development.

Detailed Description
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The 1993 World Bank World Development Report (1) delivered a strong but sad reminder of the dramatic scale of suffering and death among preschool children attributable to pneumonia (2.7million in 1990) and diarrhea (another 2.5million deaths). In terms of disability adjusted life years (DALYS) lost, in 0-4 years old children, respiratory infections account for 18.5% and 17.6% (in boys & girls respectively) and diarrhea accounts of another 16.2% and 15.7% respectively. The development of effective interventions to reduce morbidity from these illnesses has become a humanitarian, economic and political imperative and essential in achieving the morbidity and mortality reduction goals that the World Summit for Children set a decade ago. Therapy with Oral Rehydration Solution (ORS) for diarrhea, a cornerstone of the universal strategy for child survival, has low compliance due to having no effect on duration of diarrhea and has mixed impact on child mortality (2-5). Present strategies for containing morbidity and mortality due to respiratory infection focuses primarily on antibiotic treatment. Increasing prevalence of antibiotic resistant strains, poses a problem with the current strategy. Lack of any truly effective and affordable preventive vaccine, for both diarrhea and pneumonia has aroused considerable interest in food based preventive interventions. In the recent years increasing recognition and evidence regarding the role of Probiotics, and micronutrients like Zinc, as both preventive and therapeutic agents against infections has made them a potential and promising candidate. This study is in fact two trial run concurrently with two milk preparation one fortified with pre and Probiotics and second fortified with micronutrients and each having same milk unfortified as control.

Official Title
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Evaluating Efficacy of Milk Fortified With Bifidus DR10-Oligosaccharides, Zinc and Iron in Reducing Morbidity Due to Diarrhea, Pneumonia and Improving Growth and Development in Children Ages 13-36 Months

Conditions
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Pneumonia, Diarrhea, Febrile Illness, Growth, Child Development

Intervention / Treatment
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* Drug: Micronutrient (Zinc and Iron) fortification
* Drug: Pre and Probiotic fortification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 12-36 months at enrollment Resident of Sangam Vihar and likely to be in the area for 1 year. Parents consenting to participate in the trial. Exclusion Criteria: Children who have been given complete therapeutic/preventive course of Iron in the last 6 months. Children currently as part of a different Iron/Zinc supplementation program. Children known to be allergic to milk. Children who are severely malnourished and requiring hospitalization.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Micronutrient (Zinc and Iron) fortification|nan|
|Drug: Pre and Probiotic fortification|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea |  |  | 
| Pneumonia |  |  | 
| Febrile illness |  |  | 
| Growth |  |  | 
| Development |  |  | 
| Activity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron status |  |  | 
| Zinc status |  |  | 
| Colonization |  |  | 
| Copper status |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zinc, Iron, Probiotics, Prebiotics, Child health, Milk fortification, Randomized controlled trial