A Phase 2/3 interventional study of Anti-rotavirus protein and Maltodextrin in Rotavirus Gastroenteritis, sponsored by Christian Medical College, Vellore, India. Completed at 1 site in India. Open to participants aged 6 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-04.
Sponsored by Christian Medical College, Vellore, India · Phase 2/3, Interventional, and Prevention
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.
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.
243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.
This study's enrollment of 330 is above the median of 126 across 160 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →Christian Medical College, Vellore, India is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Dietary Supplement: Anti-rotavirus protein
Dietary Supplement: Maltodextrin
11mg ARP In 1 Gm Product Daily For 12 Months, given in orange juice
Maltodextrin 1 gm daily
Incidence of rotavirus gastroenteritis
Time frame: One year after recruitment
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
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Christian Medical College, Vellore, India