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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00255385
Enrollment
1200
Registered
2005-11-18
Start date
2002-04-30
Completion date
2004-04-30
Last updated
2005-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Diarrhea, Febrile Illness, Growth, Pneumonia

Keywords

Zinc, Iron, Probiotics, Prebiotics, Child health, Milk fortification, Randomized controlled trial

Brief summary

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

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.

Interventions

DRUGMicronutrient (Zinc and Iron) fortification
DRUGPre and Probiotic fortification

Sponsors

Annamalai University
CollaboratorOTHER
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Activity
Pneumonia
Febrile illness
Growth
Development
Diarrhea

Secondary

MeasureTime frame
Zinc status
Colonization
Copper status
Iron status

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026