Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months: a Double-blind, Randomized, Placebo-controlled Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Effect of Probiotics on Infections in Infants.
- Sponsor
- Fonterra Research Centre
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months.
Detailed Description
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 supplementation has been utilized in previous studies of childhood infections with promising results. In this study, the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months will be determined. The subjects will receive follow-on formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20), 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10), or placebo formula for at least three feeds per day for 12 weeks.
Investigators
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.
Outcomes
Primary Outcomes
The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
Time Frame: 12 weeks
The primary endpoint of this clinical trial is the proportion of subjects with one or more of the following confirmed bacterial or viral infections at any time during the study: fever \> 37.5ºC (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.
Secondary Outcomes
- Cumulative days with infectious symptoms(12 weeks)
- Cumulative number of infectious episodes(12 weeks)
- Infant Characteristics Questionnaire(12 weeks)
- Treatments for infectious episodes(12 weeks)
- Adverse events(12 weeks)
- Stool frequency(12 weeks)
- Stool Consistency(12 weeks)