This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement

This study has been completed.
Karolinska Institutet
Information provided by (Responsible Party):
Christian Medical College, Vellore, India Identifier:
First received: December 21, 2010
Last updated: February 3, 2015
Last verified: February 2015
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • IgA And IgG Antibody Response To Rotavirus [ Time Frame: At 4, 8 And 12 Months after recruitment ]
  • Weight For Height Z Score [ Time Frame: At 6 and 12 months after recruitment ]
  • Intestinal Function by lactulose:mannitol [ Time Frame: at 3, 6, 9 and 12 months ]
  • Characterization of strains causing rotavirus gastroenteritis [ Time Frame: Over 12 months ]
  • Incidence of adverse events [ Time Frame: Over 12 months ]

Enrollment: 330
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 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.

Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01265355

Christian Medical College
Vellore, TN, India, 632004
Sponsors and Collaborators
Christian Medical College, Vellore, India
Karolinska Institutet
Principal Investigator: Gagandeep Kang, MD Christian Medical College, Vellore, India
Study Director: Uma Raman, MDS Christian Medical College, Vellore, India
  More Information

Responsible Party: Christian Medical College, Vellore, India Identifier: NCT01265355     History of Changes
Other Study ID Numbers: CMCLB001
Study First Received: December 21, 2010
Last Updated: February 3, 2015

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases processed this record on September 21, 2017