Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement

NCT01265355 | Completed Phase 2 DMC

• 1 other identifier: CMCLB001
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of rotavirus gastroenteritis

  One year after recruitment

Secondary Outcomes (5)

• IgA And IgG Antibody Response To Rotavirus

  At 4, 8 And 12 Months after recruitment

• Weight For Height Z Score

  At 6 and 12 months after recruitment

• Intestinal Function by lactulose:mannitol

  at 3, 6, 9 and 12 months

• Characterization of strains causing rotavirus gastroenteritis

  Over 12 months

• Incidence of adverse events

  Over 12 months

Study Arms (2)

Anti-rotavirus protein

EXPERIMENTAL

Dietary Supplement: Anti-rotavirus protein

Maltodextrin

PLACEBO COMPARATOR

Dietary Supplement: Maltodextrin

Interventions

Anti-rotavirus protein DIETARY_SUPPLEMENT

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

Anti-rotavirus protein

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin 1 gm daily

Maltodextrin

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 exclusively breast fed for at least four months

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Medical College, Vellore, India: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

• Gagandeep Kang, MD

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

• Uma Raman, MDS

  Christian Medical College, Vellore, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 23, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

IN (1)