Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Condition: Immunity to Oral Rotavirus Vaccine; Immunity to Oral Polio Vaccine; Shedding of Oral Rotavirus Vaccine
MeSH terms: Poliomyelitis
Intervention: Probiotic; Zinc; Probiotic placebo; Zinc placebo; Rotavirus vaccine; Oral polio vaccine
Intervention description: 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 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.
Intervention MeSH terms: Zinc; Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 620.0
Sex: All
Minimum age: 5 Weeks
Maximum age: 16 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: rotavirus; polio; zinc supplement; probiotic supplement; rotavirus vaccine shedding

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.
    

Eligibility criteria:

        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)