Community based prevention of rotavirus gastroenteritis by a functional food supplement

Production and delivery of antibody fragments against gastrointestinal pathogens by lactobacilli

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003002

Enrollment

330

Registered

2010-11-24

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: Yeast expressed anti-rotavirus protein: 11mg ARP in 1 gm product daily for 12 months Control Intervention1: Maltodextrin: 1 gm daily for 12 months

Eligibility

Inclusion criteria

Inclusion criteria: Healthy child aged 6 to 12 months, families resident in the study area, willing to participate and available for follow up for a period of one year Normal birth weight ( > 2.5 kg), child breast fed for at least four months

Exclusion criteria

Exclusion criteria: Families not available for a follow up period of one year Children with any atopic conditions Children with gross congenital anomalies including cardiovascular, renal or hepatic disease Children with syndromic or serological evidence of HIV infection

Design outcomes

Primary

Measure	Time frame
Rotavirus gastroenteritisTimepoint: Total number of episodes in the 12 month follow up period	—

Secondary

Measure	Time frame
IgA and IgG antibody response to rotavirus at 4, 8 and 12 month height for age Z score at 6 and 12 months Intestinal function by lactulose:mannitol test at 3, 6 9 and 12 months Characterization of circulating rotavirus strains Timepoint: As specified above and over entire follow up duration	—

Countries

India

Contacts

Public ContactGagandeep Kang

gkang@cmcvellore.ac.in9894070266

Outcome results