Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement

Rotavirus Gastroenteritis Clinical Trial

Official title:

Community Based Prophylaxis for Rotavirus Gastroenteritis in Children by an Anti-rotavirus Protein Based Food Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265355
• Other study ID #: CMCLB001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 21, 2010
• Last updated: February 3, 2015
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2015
• Source: Christian Medical College, Vellore, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical ResearchIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Dietary Supplement:
• Anti-rotavirus protein
11mg ARP In 1 Gm Product Daily For 12 Months, given in orange juice
• Maltodextrin
Maltodextrin 1 gm daily

Locations

Country	Name	City	State
India	Christian Medical College	Vellore	TN

Sponsors (2)

Lead Sponsor	Collaborator
Christian Medical College, Vellore, India	Karolinska Institutet

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of rotavirus gastroenteritis		One year after recruitment	No
Secondary	IgA And IgG Antibody Response To Rotavirus		At 4, 8 And 12 Months after recruitment	No
Secondary	Weight For Height Z Score		At 6 and 12 months after recruitment	No
Secondary	Intestinal Function by lactulose:mannitol		at 3, 6, 9 and 12 months	No
Secondary	Characterization of strains causing rotavirus gastroenteritis		Over 12 months	No
Secondary	Incidence of adverse events		Over 12 months	Yes