Clinical trial NCT01265355: Community Based Prevention of Rotavirus Gastroenteritis by a Functional Food Supplement
Official title: Community Based Prophylaxis for Rotavirus Gastroenteritis in Children by an Anti-rotavirus Protein Based Food Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Rotavirus Gastroenteritis
Lead sponsor: Christian Medical College, Vellore, India
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2010-12-23
Enrollment: 330
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Incidence of rotavirus gastroenteritis
timeFrame: One year after recruitment
Secondary outcomes:
measure: IgA And IgG Antibody Response To Rotavirus
timeFrame: At 4, 8 And 12 Months after recruitment
measure: Weight For Height Z Score
timeFrame: At 6 and 12 months after recruitment
measure: Intestinal Function by lactulose:mannitol
timeFrame: at 3, 6, 9 and 12 months
measure: Characterization of strains causing rotavirus gastroenteritis
timeFrame: Over 12 months
measure: Incidence of adverse events
timeFrame: Over 12 months
Other outcomes:
Locations:
city: Vellore
country: India
facility: Christian Medical College
state: TN
Study officials:
affiliation: Christian Medical College, Vellore, India
name: Gagandeep Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian Medical College, Vellore, India
name: Uma Raman, MDS
role: STUDY_DIRECTOR
References: