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Prevention of Rotavirus infection and diarrhoea by Cow Complex Milk Lipid (Dairy Dietary Supplement) in children aged 8-24 months living within a community setting in India

Prevention of Rotavirus infection and diarrhoea by bovine Complex Milk Lipid: a randomized, controlled trial of children aged 8-24 months living within a community setting in India

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000873
Enrollment
450
Registered
2009-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Bovine Complex Milk Lipid Powder: 5 gm sachet OD for 12 Weeks Control Intervention1: Whole Milk Powder: 5 gm sachet OD for 12 Weeks

Sponsors

LactoPharma, New Zealand
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female infant aged 8-24 months 2. Living at home within a community setting 3. 1 child per family unit to be randomized into the trial 4. With or without history of diarrhea 5. Located near to designated study site(s)

Exclusion criteria

Exclusion criteria: 1. Prior vaccination for Rotavirus 2. Sibling currently randomized into the trial 3. Allergy to milk or dairy products 4. Any serious medical condition, including prolonged hospitalization for diarrhea

Design outcomes

Primary

MeasureTime frame
Total number of days with diarrhoea over study periodTimepoint:—

Secondary

MeasureTime frame
-Occurrence, duration and severity of diarrhoea over study period -Rotavirus load in stool samples at baseline and 12 weeks -General HealthTimepoint:—

Countries

India

Contacts

Public ContactDr.Ashish Rastogi
ashish@excellifesciences.com0120-4022600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026