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Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement

NCT01265355 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2015-02-04

No results posted yet for this study

Summary

Rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. The investigators hypothesize that use of a food based prophylactic will decrease incidence of rotavirus infection in young children in south India, prevent intestinal damage and overall result in lower infection rates and better gut function. This trial will evaluate the efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or antibody fragments expressed in yeast or placebo are given daily as a food supplement to children between the ages of 6 and 12 months. The children will followed for one year and rates of rotavirus diarrhoea, antibody responses and gut function will be compared between children receiving antibody fragments or placebo.

Conditions

  • Rotavirus Gastroenteritis

Interventions

DIETARY_SUPPLEMENT

Anti-rotavirus protein

11mg ARP In 1 Gm Product Daily For 12 Months, given in orange juice

DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin 1 gm daily

Sponsors & Collaborators

Principal Investigators

  • Gagandeep Kang, MD · Christian Medical College, Vellore, India

  • Uma Raman, MDS · Christian Medical College, Vellore, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • India

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01265355 on ClinicalTrials.gov