Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines (NCT01616693) | Clinical Trial Compass
CompletedPhase 4
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
India620 participantsStarted 2012-07
Plain-language summary
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.
Who can participate
Age range
5 Weeks – 16 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants 35-41 days old
* 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 history of atopic symptoms
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine
Timeframe: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine
2
Geometric Mean Concentration of Rotavirus-specific IgA
Timeframe: from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine