Sponsor study identifier
interventional
620
1 country
1
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function. This study enrolled infants 5 weeks old living in urban Vellore, India to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix,GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Probiotics and zinc (or placebo) were provided for six weeks. A single dose of test product was administered daily one week prior to first study dose of rotavirus and polio vaccines through 1 week following second study dose of rotavirus and polio vaccines.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2012
Actual (reported)June 12, 2012
Actual (reported)July 2012
Date type not reportedThis date has not been verified as actual or estimated.
July 2013
Actual (reported)July 2013
Actual (reported)November 30, 2018
Actual (reported)Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine
Defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (IgA) antibodies at a concentration ≥20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age. Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).
from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
Geometric Mean Concentration of Rotavirus-specific IgA
Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus was administered (14 weeks of age). Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age).
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
A capsule that contains at least 1 x 10\^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.
Christian Medical Center, Vellore
Vellore, Tamil Nadu, 632 004, India
Gagandeep Kang, MD, PhD
Christian Medical Center, Vellore, India
620 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2012
First Posted
June 12, 2012
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children
from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)
from first dose of OPV to 4 weeks after last dose of OPV
Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1
0, 4 and/or 7 day post dose 1 of rotavirus vaccine
Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2
0, 4 and/or 7 day post dose 2 of rotavirus vaccine
Serious Adverse Events (SAEs)
from first day of study to 4 weeks after last dose
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.
The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2013
Actual (reported)Study Completion
July 2013
Actual (reported)Last Updated
December 26, 2018
Results First Posted
November 30, 2018
Record last verified: 2018-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: