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

Fonterra

Status: Completed

Conditions: Effect of Probiotics on Infections in Infants.

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus rhamnosus; Dietary Supplement: Bifidobacterium animalis subsp. lactis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01724203

111104-SUS-FON-ICP-MS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 3 patient groups, including a placebo group

Lactobacillus rhamnosus

Active Comparator group

Description:

Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.

Treatment:

Dietary Supplement: Lactobacillus rhamnosus

Bifidobacterium animalis subsp. lactis

Active Comparator group

Description:

Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks.

Treatment:

Dietary Supplement: Bifidobacterium animalis subsp. lactis

Placebo

Placebo Comparator group

Description:

Placebo formula without probiotics at least three times daily for 12 weeks.

Treatment:

Dietary Supplement: Placebo