Back to resultsEffect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.
Primary Purpose
Effect of Probiotics on Infections in Infants.
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lactobacillus rhamnosus
Bifidobacterium animalis subsp. lactis
Placebo
Sponsored by
About this trial
This is an interventional health services research trial for Effect of Probiotics on Infections in Infants. focused on measuring Probiotics for infants, Bacterial and viral infections in infants
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.
Sites / Locations
- Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Lactobacillus rhamnosus
Bifidobacterium animalis subsp. lactis
Placebo
Arm Description
Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.
Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks.
Placebo formula without probiotics at least three times daily for 12 weeks.
Outcomes
Primary Outcome Measures
The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
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 Outcome Measures
Cumulative days with infectious symptoms
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
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
Parents will record the number of infant defecations each day in a diary during the 12-week supplementation period.
Stool Consistency
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
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
Treatments that are taken to alleviate infectious symptoms will be documented in a daily diary.
Adverse events
Adverse events will be recorded in the daily diary and at study visits during the 12-week supplementation period.
Full Information
NCT ID
NCT01724203
First Posted
November 7, 2012
Last Updated
October 10, 2013
Sponsor
Fonterra Research Centre
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Sprim Advanced Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01724203
Brief Title
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
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fonterra Research Centre
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Sprim Advanced Life Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Probiotics on Infections in Infants.
Keywords
Probiotics for infants, Bacterial and viral infections in infants
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus rhamnosus
Arm Type
Active Comparator
Arm Description
Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks.
Arm Title
Bifidobacterium animalis subsp. lactis
Arm Type
Active Comparator
Arm Description
Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo formula without probiotics at least three times daily for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus rhamnosus
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium animalis subsp. lactis
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cumulative days with infectious symptoms
Description
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.
Time Frame
12 weeks
Title
Cumulative number of infectious episodes
Description
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.
Time Frame
12 weeks
Title
Stool frequency
Description
Parents will record the number of infant defecations each day in a diary during the 12-week supplementation period.
Time Frame
12 weeks
Title
Stool Consistency
Description
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.
Time Frame
12 weeks
Title
Infant Characteristics Questionnaire
Description
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.
Time Frame
12 weeks
Title
Treatments for infectious episodes
Description
Treatments that are taken to alleviate infectious symptoms will be documented in a daily diary.
Time Frame
12 weeks
Title
Adverse events
Description
Adverse events will be recorded in the daily diary and at study visits during the 12-week supplementation period.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoyang Sheng, Dr
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36004715
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):341-353. doi: 10.3920/BM2022.0041. Epub 2022 Aug 25.
Results Reference
derived
Learn more about this trial
Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.
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