Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.
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|ClinicalTrials.gov Identifier: NCT01724203|
Recruitment Status : Completed
First Posted : November 9, 2012
Last Update Posted : October 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Effect of Probiotics on Infections in Infants.||Dietary Supplement: Lactobacillus rhamnosus Dietary Supplement: Bifidobacterium animalis subsp. lactis Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||December 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Active Comparator: Lactobacillus rhamnosus
Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.
Dietary Supplement: Lactobacillus rhamnosus
Active Comparator: Bifidobacterium animalis subsp. lactis
Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks.
Dietary Supplement: Bifidobacterium animalis subsp. lactis
Placebo Comparator: Placebo
Placebo formula without probiotics at least three times daily for 12 weeks.
Dietary Supplement: Placebo
- 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.
- Cumulative days with infectious symptoms [ Time Frame: 12 weeks ]Cumulative number of days with infectious symptoms will be defined as the total number of days during the study on which a subject has symptoms of a confirmed infection. Confirmed infections that count toward the primary endpoint include: fever >37.5°C (axillary), upper respiratory tract infection, lower respiratory tract infection, pneumonia, strep throat, diarrhea, and otitis media.
- Cumulative number of infectious episodes [ Time Frame: 12 weeks ]Cumulative number of infectious episodes will be defined as the total number of infectious episodes (defined as presence of one of more symptoms of a confirmed infection) experienced during the study. An infectious episode will be defined as a period when symptoms of a confirmed infection last for more than 24 hours and are followed by at least 3 days of no symptoms.
- Stool frequency [ Time Frame: 12 weeks ]Parents will record the number of infant defecations each day in a diary during the 12-week supplementation period.
- Stool Consistency [ Time Frame: 12 weeks ]Parents will rate the consistency of each infant bowel movement by using the Bristol Stool Scale Form. Parents will record stool consistency each day during the 12-week supplementation period.
- Infant Characteristics Questionnaire [ Time Frame: 12 weeks ]The Infant Characteristic Questionnaire for infants approximately 6 months old (ICQ-6) measures parental perception of infant temperament, focusing on difficult temperament 8. The questionnaire is comprised of 24 items describing infant behavior. The parent or primary caregiver ranks each item on a 7-point scale, indicating the level of perceived difficulty in dealing with the described behavior. Four subscales have been identified through principal components analyses: Fussy/Difficult, Unadaptable, Dull, and Unpredictable.
- Treatments for infectious episodes [ Time Frame: 12 weeks ]Treatments that are taken to alleviate infectious symptoms will be documented in a daily diary.
- Adverse events [ Time Frame: 12 weeks ]Adverse events will be recorded in the daily diary and at study visits during the 12-week supplementation period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724203
|Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine|
|Shanghai, Shanghai, China, 200092|
|Principal Investigator:||Xiaoyang Sheng, Dr||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|