Clinical trial NCT01724203: Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Probiotics on Infections in Infants.
Keywords: Probiotics for infants
Bacterial and viral infections in infants
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Sprim Advanced Life Sciences
First posted: 2012-11-09
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
timeFrame: 12 weeks
Secondary outcomes:
measure: Cumulative days with infectious symptoms
timeFrame: 12 weeks
measure: Cumulative number of infectious episodes
timeFrame: 12 weeks
measure: Stool frequency
timeFrame: 12 weeks
measure: Stool Consistency
timeFrame: 12 weeks
measure: Infant Characteristics Questionnaire
timeFrame: 12 weeks
measure: Treatments for infectious episodes
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiaoyang Sheng, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dekker J, Quilter M, Qian H. Comparison of two probiotics in follow-on formula: Bifidobacterium animalis subsp. lactis HN019 reduced upper respiratory tract infections in Chinese infants. Benef Microbes. 2022 Oct 4;13(4):341-354. doi: 10.3920/BM2022.0041. Epub 2022 Aug 25.