Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.

Launched by FONTERRA RESEARCH CENTRE · Nov 8, 2012

Keywords

ClinConnect Summary

Probiotics are live bacteria that offer a health benefit to the host when administered via the diet in adequate amounts. Probiotic supplementation is safe for use in infants to the elderly and has demonstrated beneficial effects for a wide variety of health conditions such as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel disease. The immune-enhancing benefits of probiotics are attractive, particularly for infants, a group that is particularly prone to a variety of infections, e.g. respiratory tract infection, strep throat, and diarrhea. Probiotic suppleme...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age 6 to 12 months.
• • Known vaccination history.
• • Ability of the participant's parent or legal guardian to comprehend the full nature and purpose of the study including possible risks and side effects.
• • Parental or legal guardian's consent to the study and willing to comply with study procedures.
• Exclusion Criteria:
• • Symptoms of any infection at screening.
• • History of ≥5 infections in the previous 2 months.
• • Lactose intolerance or unable to drink milk.
• • Leukopenia or leukocytosis.
• • Immunodeficient or use of immunosuppressive drugs.
• • Use of antibiotic and anti-inflammatory medications within the last 2 weeks.
• • Use of products containing prebiotics or probiotics within the last 2 weeks.
• • Use of low-lactose or lactose-free infant or follow-on formula within the last 2 weeks.
• • Hepatitis B or C.
• • Medications or supplements that may affect subject safety or confound study outcomes in the opinion of the investigator.
• • Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
• • Participation in another study with any investigational product within 3 months of screening.
• • Any other condition that, in the investigator's opinion, may preclude the subject's ability to safely complete the trial.

Trial Officials