Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
NCT ID: NCT01616693
Last Updated: 2018-12-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
620 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Probiotics for Infectious Diarrhea in Children in South India
NCT01130792
Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients with Ventriculitis
NCT06151392
Comparing the Efficacy of Two Oral Rehydration Solutions, With or Without the Probiotic Lactobacillus Reuteri DSM 17938 and Zinc, on the Duration and Severity of Acute Gastroenteritis in 6 - 36 Months Old Children in Out-patient Care
NCT01737086
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
NCT02722993
Efficacy and Safety of Oral Lactobacillus Plantarum GUANKE (CGMCC NO.21720) in Enhancement of Antibody Level After SARS-CoV-2 Vaccination (Trial 1)
NCT05194033
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus immunoglobulin A (IgA) antibodies) among Indian infants receiving zinc supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc placebo.
2. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus IgA antibodies) among Indian infants receiving probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a probiotic placebo.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zinc and probiotic
Received daily zinc and probiotic supplements, in addition to rotavirus vaccine and trivalent oral polio vaccines.
Probiotic
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.
Zinc
Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Zinc alone
Received daily zinc and probiotic placebo supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Zinc
Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo
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.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Probiotic alone
Received daily zinc placebo and probiotic supplement, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic
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.
Zinc placebo
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.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Placebo
Received daily zinc placebo and probiotic placebo, in addition to rotavirus vaccine and trivalent oral polio vaccine.
Probiotic placebo
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.
Zinc placebo
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.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Probiotic
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.
Zinc
Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
Probiotic placebo
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.
Zinc placebo
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.
Rotavirus vaccine
1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
Oral polio vaccine
A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Live in area under surveillance
* Current weight ≥3.2 kg
* No syndromic evidence of immunocompromise as determined by medical doctor
* No prior illness requiring hospitalization
* No current medical condition as determined by medical doctor which precludes study involvement
* Available for follow up for duration of study (through approximately 14 weeks of age)
* Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent
Exclusion Criteria
* Child has a known digestive system defect
* Child has history of chronic diarrhea
* Child has major congenital anomalies
* Child has received a prior dose of rotavirus vaccine
* Child has received a prior dose of polio vaccine (beyond the birth dose)
5 Weeks
16 Weeks
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Christian Medical College, Vellore, India
OTHER
Ministry of Science and Technology, India
OTHER_GOV
PATH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gagandeep Kang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Christian Medical Center, Vellore, India
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Christian Medical Center, Vellore
Vellore, Tamil Nadu, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CMC ZP 2012; PATH HS-658
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.