Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Christian Medical College, Vellore, India.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by:
Christian Medical College, Vellore, India
ClinicalTrials.gov Identifier:
NCT01265355
First received: December 21, 2010
Last updated: December 22, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Rotavirus Gastroenteritis
Dietary Supplement: Anti-rotavirus protein
Dietary Supplement: Maltodextrin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Community Based Prophylaxis for Rotavirus Gastroenteritis in Children by an Anti-rotavirus Protein Based Food Supplement

Resource links provided by NLM:


Further study details as provided by Christian Medical College, Vellore, India:

Primary Outcome Measures:
  • Incidence of rotavirus gastroenteritis [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IgA And IgG Antibody Response To Rotavirus [ Time Frame: At 4, 8 And 12 Months after recruitment ] [ Designated as safety issue: No ]
  • Weight For Height Z Score [ Time Frame: At 6 and 12 months after recruitment ] [ Designated as safety issue: No ]
  • Intestinal Function by lactulose:mannitol [ Time Frame: at 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Characterization of strains causing rotavirus gastroenteritis [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Over 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-rotavirus protein Dietary Supplement: Anti-rotavirus protein
11mg ARP In 1 Gm Product Daily For 12 Months, given in orange juice
Placebo Comparator: Maltodextrin Dietary Supplement: Maltodextrin
Maltodextrin 1 gm daily

Detailed Description:

The study will be carried out in an urban slum area in Vellore, south India. Children between the ages of 6 and 12 months will be recruited for participation in the study. They will be randomized to receive supplementation with ARP or placebo, and will be followed for a period of one year, with weekly home visits and monitoring of all episodes of diarrhoea. In addition, every two weeks, surveillance stool samples will be collected and tested for rotavirus to identify asymptomatic infections by PCR. All episodes of diarrhoea will be investigated intensively for bacterial, viral and parasitic agents of diarrhoea using both conventional and molecular techniques and all cases will be treated appropriately at the study clinic or referral hospital as required. Monthly anthropometric measurements will be carried out to estimate rates of growth and to identify growth faltering. Blood samples will be taken at 4, 8 and 12 months for estimation of anti-rotavirus IgA and IgG antibodies. Studies on intestinal absorption and permeability will be carried out at recruitment, 6 and 12 months by the lactulose:mannitol test (measured by HPLC detection of sugars). All rotavirus strains obtained will be characterized by genotyping.

  Eligibility

Ages Eligible for Study:   6 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 exclusively breast fed for at least four months

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265355

Contacts
Contact: Gagandeep Kang, MD, PhD +914162282052 gkang@cmcvellore.ac.in
Contact: George Mathew, MS +914162284202 princi@cmcvellore.ac.in

Locations
India
Christian Medical College Not yet recruiting
Vellore, TN, India, 632004
Contact: Gagandeep Kang, MD, PhD    +914162282052    gkang@cmcvellore.ac.in   
Principal Investigator: Gagandeep Kang, MD, PhD         
Sub-Investigator: Jayaprakash Muliyil, MD, DrPH         
Sub-Investigator: Anuradha Bose, MD,FRCPCH         
Sponsors and Collaborators
Christian Medical College, Vellore, India
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Principal, Christian Medical College, Vellore
ClinicalTrials.gov Identifier: NCT01265355     History of Changes
Other Study ID Numbers: CMCLB001
Study First Received: December 21, 2010
Last Updated: December 22, 2010
Health Authority: India: Indian Council of Medical Research
India: Institutional Review Board

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014