HealthyNCT00599430
Evaluation of Probiotics on Symptoms of Upper Respiratory Tract Infections
A study testing Lactobacillus acidophilus NCFM and Combination of Lactobacillus acidophilus and Bifidobacterium lactis in people with Healthy, run by Danisco at 1 site in China.
Trial summary
The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus acidophilus NCFM and Combination of Lactobacillus acidophilus and Bifidobacterium lactis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- Nov 2005to May 2006
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-5 years of normal nutritional status and health
Who cannot join
- Contraindications to dairy products (lactose intolerance or cow's milk allergy)
- Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
- Chronic cough from recurring respiratory distress-related diseases
- Hirschsprung's disease
- Cystic fibrosis
- Other metabolic, neurological, or anatomic alteration that predisposes participation
- Intake of probiotics within the last 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children
The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.
- Conditions
- Healthy
- Being tested
- Placebo, Lactobacillus acidophilus NCFM, Combination of Lactobacillus acidophilus and Bifidobacterium lactis
- Keywords
- Probiotic, Lactobacillus, NCFM, Bifidobacterium, Healthy children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Inert excipient
Lactobacillus acidophilus NCFMDietary supplement
1e10 CFU/day
Combination of Lactobacillus acidophilus and Bifidobacterium lactisDietary supplement
1x10e10 CFU/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| Active 1 | Active comparator | One probiotic strain Receives: Dietary Supplement: Lactobacillus acidophilus NCFM |
| Active 2 | Active comparator | Blend of two strains Receives: Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers.
Measured: Daily for six months
Secondary outcomes (1)
To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startNov 2005
- Primary completionMay 2006
- Study completionMay 2006
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 HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charlie Zhang, Study director, Sprim Advanced Life SciencesCheryl Riefer, Study chair, Sprim Advanced Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599430
- Sponsor's protocol ID
- Danisco - Mao
- Other IDs
- 06-02-D-011
- Status last verified
- Jan 2008
- First submitted
- 3 Jan 2008
- Last updated
- 23 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27.
PubMed 19651563
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children
- ClinicalTrials.gov ID
- NCT00599430
- Acronym / sponsor ID
- Danisco - Mao
- Conditions
- Healthy
- Keywords
- Probiotic, Lactobacillus, NCFM, Bifidobacterium, Healthy children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 23 Jan 2008 (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 aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| Active 1 | Active comparator | Dietary Supplement: Lactobacillus acidophilus NCFMOne probiotic strain |
| Active 2 | Active comparator | Dietary Supplement: Combination of Lactobacillus acidophilus and Bifidobacterium lactisBlend of two strains |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 3-5 years of normal nutritional status and health
Key exclusion criteria (7 listed)
- Contraindications to dairy products (lactose intolerance or cow's milk allergy)
- Indicators of inflammatory disease, intestinal disease, Crohn's disease, colitis, celiac disease
- Chronic cough from recurring respiratory distress-related diseases
- Hirschsprung's disease
- Cystic fibrosis
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 |
|---|---|---|
| PlaceboInert excipient | Dietary supplement | 1 |
| Lactobacillus acidophilus NCFM1e10 CFU/day | Dietary supplement | Active 1 |
| Combination of Lactobacillus acidophilus and Bifidobacterium lactis1x10e10 CFU/day | Dietary supplement | Active 2 |
Primary outcome
To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers.
Time frame: Daily for six months
1 secondary outcome
To determine if children who consume a beverage fortified with a probiotic miss fewer days of preschool as measured by illness.
Time frame: Six months
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 23 Jan 2008.
- Derived from this study: PubMed 19651563Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27.
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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.
Charlie Zhang study director
Sprim Advanced Life Sciences
Cheryl Riefer study chair
Sprim Advanced Life Sciences
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 acidophilus NCFM and Combination of Lactobacillus acidophilus and Bifidobacterium lactis in people with Healthy, run by Danisco 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 1 inclusion and 7 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 23 Jan 2008. 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?
To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers. (time frame: Daily for six months). 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 NCT00599430, 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 23 Jan 2008.