Days Absent From Day CareProbiCompNCT02032056
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
A study testing Probiotic (10^9 CFU/day) and Probiotic (10^8 CFU/day) in people with Days Absent From Day Care and Respiratory Tract Infections, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons. Read more about this study
- Who is it for?
- Ages 9 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Days Absent From Day Care, Respiratory Tract Infections, Gastrointestinal Infections
- What is being tested?
- Probiotic (10^9 CFU/day) and Probiotic (10^8 CFU/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to May 2014
- 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 9 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9 - 12 1/2 month at intervention start
- Start in daycare 4 +/- 2 weeks after intervention start
- Single born
Who cannot join
- Children born before 37th gestational week
- Children with a birth weight < 2500 g
- Children suffering from severe chronic illness
- Children receiving regular medication
- Children who have received antibiotics within a month before intervention start
- Children whose parents do not speak Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen
Frederiksberg, 1958
About this study
Official title: The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period
The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.
- Conditions
- Days Absent From Day Care, Respiratory Tract Infections, Gastrointestinal Infections, Allergy
- Being tested
- Probiotic (10^9 CFU/day), Probiotic (10^8 CFU/day), Placebo
- Keywords
- Infections, Allergy, Immune function, Microbiota, infant
- Medical subject headings
- Respiratory Tract Infections, Hypersensitivity, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic (10^9 CFU/day)Dietary supplement
Also called Bifidobacterium animalis ssp. Lactis (BB12)
Probiotic (10^8 CFU/day)Dietary supplement
Also called Bifidobacterium animalis ssp. Lactis (BB12)
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| probiotic (10^9 cfu/day) | Experimental | Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, provided as powder in a sachet which can be added to food or drink. Receives: Dietary Supplement: Probiotic (10^9 CFU/day) |
| probiotic (10^8 cfu/day) | Experimental | Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^8 cfu/day, provided as powder in a sachet which can be added to food or drink. Receives: Dietary Supplement: Probiotic (10^8 CFU/day) |
| Placebo | Placebo comparator | provided as powder in a sachet which can be added to food or drink. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days absent from day care due to respiratory and gastrointestinal infections
Recorded weekly by the parents using web-based questionnaires
Measured: Up to 6 month
Secondary outcomes (10)
Acute upper respiratory tract infections
Number of days with acute upper respiratory tract infections (URTI); Number of children with at least 1 episode of URTI; Number of children with at least 3 episodes of URTI; Number of URTI episodes/child/year; Duration of URTI episodes (days);
Additionally,symptoms of cold (defined as 2 days with runny/stuffy nose or cough)
Recorded by the parents daily/weekly using web-based questionnaires.
Measured: Up to 6 month
Acute lower respiratory infections
Number of children with at least 1 episode of a lower respiratory tract infection (LRTI).
LRTI include bronchitis and pneumonia
Recorded by the parents weekly using web-based questionnaires.
Measured: Up to 6 month
Gastrointestinal infections
Number of children with at least 1 episode of diarrhea; Duration of episodes with diarrhea(days); Number of episodes/child/year with diarrhea; Number of days with vomiting.
Recorded by the parents daily using web-based questionnaires
Measured: Up to 6 month
Fever
Number of days with fever
Recorded by the parents using web-based questionnaires
Measured: Up to 6 month
Antibiotic use
Number of treatments with antibiotics during the intervention period
Recorded weekly by the parents using web-based questionnires
Measured: Up to 6 month
Allergies
Number of children developing allergies during the intervention period (asthma, allergic rhinitis, atopic dermatitis, food allergies); Age for diagnosis of allergies; Use of medication due to allergies.
Recorded by the parents monthly using web-based questionnaires
Measured: Up to 6 month
Absence from day care due to illness other than infections
Number of days the child is absent from day care due to illness, which is not due to infections.
Recorded by the parents weekly using web-based questionnaires
Measured: Up to 6 month
Parental absence from work due to illness of the child
Number of days a parent is absent from work due to illness of the child (infections and other illnesses, respectively)
Recorded by the parents weekly using web-based questionnaires
Measured: Up to 6 month
Medical visits
Number of visits to a doctor due to infections and other illnesses, respectively.
Recorded by the parents using web-based questionnaires
Measured: Up to 6 month
Change from baseline in Thymus size
Change in thymic size during intervention period will be evaluated using ultraound
Measured: At baseline and after 6 mo (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Changes in study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Days Absent From Day CareStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Chr Hansen, Technical University of Denmark, University of Bergen, Odense University Hospital, Statens Serum Institut
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032056
- Sponsor's protocol ID
- H-3-2013-064
- Other IDs
- H-3-2013-064
- Acronym
- ProbiComp
- Status last verified
- May 2018
- First submitted
- 20 Nov 2013
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period
- ClinicalTrials.gov ID
- NCT02032056
- Acronym / sponsor ID
- ProbiComp / H-3-2013-064
- Conditions
- Days Absent From Day Care, Respiratory Tract Infections, Gastrointestinal Infections, Allergy
- Keywords
- Infections, Allergy, Immune function, Microbiota, infant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in study design
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Council for Strategic Research, Chr Hansen, Technical University of Denmark, University of Bergen, Odense University Hospital, Statens Serum Institut
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Jan 2014 (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 intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| probiotic (10^9 cfu/day) | Experimental | Dietary Supplement: Probiotic (10^9 CFU/day)Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, provided as powder in a sachet which can be added to food or drink. |
| probiotic (10^8 cfu/day) | Experimental | Dietary Supplement: Probiotic (10^8 CFU/day)Daily intake of bifidobacterium animalis ssp. Lactis (BB12), 10^8 cfu/day, provided as powder in a sachet which can be added to food or drink. |
| Placebo | Placebo comparator | Other: Placeboprovided as powder in a sachet which can be added to food or drink. |
Who may qualify
- Ages
- 9 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 9 - 12 1/2 month at intervention start
- Start in daycare 4 +/- 2 weeks after intervention start
- Single born
Key exclusion criteria (6 listed)
- Children born before 37th gestational week
- Children with a birth weight < 2500 g
- Children suffering from severe chronic illness
- Children receiving regular medication
- Children who have received antibiotics within a month before intervention start
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 |
|---|---|---|
| Probiotic (10^9 CFU/day)Also: Bifidobacterium animalis ssp. Lactis (BB12) | Dietary supplement | probiotic (10^9 cfu/day) |
| Probiotic (10^8 CFU/day)Also: Bifidobacterium animalis ssp. Lactis (BB12) | Dietary supplement | probiotic (10^8 cfu/day) |
| Placebo | Other | Placebo |
Primary outcome
Number of days absent from day care due to respiratory and gastrointestinal infections
Time frame: Up to 6 month
Recorded weekly by the parents using web-based questionnaires
10 secondary outcomes
Acute upper respiratory tract infections
Time frame: Up to 6 month
Acute lower respiratory infections
Time frame: Up to 6 month
Gastrointestinal infections
Time frame: Up to 6 month
Fever
Time frame: Up to 6 month
Antibiotic use
Time frame: Up to 6 month
Allergies
Time frame: Up to 6 month
Absence from day care due to illness other than infections
Time frame: Up to 6 month
Parental absence from work due to illness of the child
Time frame: Up to 6 month
Medical visits
Time frame: Up to 6 month
Change from baseline in Thymus size
Time frame: At baseline and after 6 mo (end of intervention)
Results and safety
The study was stopped early (reason given: Changes in study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic (10^9 CFU/day) and Probiotic (10^8 CFU/day) in people with Days Absent From Day Care and Respiratory Tract Infections, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 May 2018. 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 Denmark. 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 was stopped early (reason given: Changes in study design). Results are not available in the source record.
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?
Number of days absent from day care due to respiratory and gastrointestinal infections (time frame: Up to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2018.