Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01265355
Other study ID # CMCLB001
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT01575197 - Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana Phase 4
Completed NCT01202201 - A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan N/A
Completed NCT00953056 - A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED) Phase 1
Completed NCT00737503 - Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab Phase 4
Completed NCT04185545 - Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates Phase 3
Completed NCT03474055 - Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India Phase 2/Phase 3
Completed NCT01236066 - Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia N/A
Completed NCT00489567 - Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden N/A
Completed NCT02584816 - Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization Phase 3
Completed NCT02062385 - Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024) Phase 3
Completed NCT02133690 - A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants Phase 3
Completed NCT01177657 - Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil N/A
Completed NCT00740935 - Impact of Systematic Infants Vaccination Against Rotavirus on Gastroenteritis Hospitalization: a Prospective Study in Brest District, France. Phase 4
Completed NCT00169455 - Assess the Immunogenicity of the Human Rotavirus (HRV) Vaccine After Reconstitution Without Buffering Agent; & Evaluate the Immunogenicity, Reactogenicity & Safety of the Vaccine After Storage for 7 d at 37°C Following 2 Doses in Healthy Infants Phase 3
Completed NCT04819412 - To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus Phase 3
Completed NCT02728869 - Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants Phase 1/Phase 2
Recruiting NCT05958771 - The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E Phase 3
Recruiting NCT01061658 - Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine Phase 1/Phase 2
Completed NCT01026779 - Rotavirus Gastroenteritis and Vaccine Usage in Rhode Island
Completed NCT01508533 - Epidemiology of Rotavirus Infection in North India Community N/A