Effect of Probiotics on Infections in Infants.NCT01724203
Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.
A study testing Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis in people with Effect of Probiotics on Infections in Infants., run by Fonterra Research Centre at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Effect of Probiotics on Infections in Infants.
- What is being tested?
- Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
China1 site
Shanghai Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
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.
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.
Read the 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.
- Being tested
- Lactobacillus rhamnosus, Bifidobacterium animalis subsp. lactis, Placebo
- Keywords
- Probiotics for infants, Bacterial and viral infections in infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosusDietary supplement
Bifidobacterium animalis subsp. lactisDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus rhamnosus | Active comparator | Formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks. Receives: Dietary Supplement: Lactobacillus rhamnosus |
| Bifidobacterium animalis subsp. lactis | Active comparator | Formula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks. Receives: Dietary Supplement: Bifidobacterium animalis subsp. lactis |
| Placebo | Placebo comparator | Placebo formula without probiotics at least three times daily for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Stool frequency
Parents will record the number of infant defecations each day in a diary during the 12-week supplementation period.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Treatments for infectious episodes
Treatments that are taken to alleviate infectious symptoms will be documented in a daily diary.
Measured: 12 weeks
Adverse events
Adverse events will be recorded in the daily diary and at study visits during the 12-week supplementation period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Probiotics on Infections in Infants.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fonterra Research Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Xiaoyang Sheng, Dr, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724203
- Sponsor's protocol ID
- 111104-SUS-FON-ICP-MS
- Status last verified
- Oct 2013
- First submitted
- 7 Nov 2012
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36004715
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01724203
- Acronym / sponsor ID
- 111104-SUS-FON-ICP-MS
- Keywords
- Probiotics for infants, Bacterial and viral infections in infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Fonterra Research CentreIndustry (pharma, biotech, devices)
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Sprim Advanced Life Sciences
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus rhamnosus | Active comparator | Dietary Supplement: Lactobacillus rhamnosusFormula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20) at least three times daily for 12 weeks. |
| Bifidobacterium animalis subsp. lactis | Active comparator | Dietary Supplement: Bifidobacterium animalis subsp. lactisFormula containing 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10) at least three times daily for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo formula without probiotics at least three times daily for 12 weeks. |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosus | Dietary supplement | Lactobacillus rhamnosus |
| Bifidobacterium animalis subsp. lactis | Dietary supplement | Bifidobacterium animalis subsp. lactis |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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.
7 secondary outcomes
Cumulative days with infectious symptoms
Time frame: 12 weeks
Cumulative number of infectious episodes
Time frame: 12 weeks
Stool frequency
Time frame: 12 weeks
Stool Consistency
Time frame: 12 weeks
Infant Characteristics Questionnaire
Time frame: 12 weeks
Treatments for infectious episodes
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Derived from this study: PubMed 36004715Dekker 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyang Sheng, Dr principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus and Bifidobacterium animalis subsp. lactis in people with Effect of Probiotics on Infections in Infants., run by Fonterra Research Centre at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with one or more of confirmed bacterial or viral infections at any time during the study (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01724203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2013; AzTrials last refreshed its copy on 7 Nov 2026.