Days Absent From DaycareProbiCompNCT02180581

Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare

A study testing Probiotic (2 * 10^9 cfu/day) in people with Days Absent From Daycare and Respiratory Tract Infections, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the intervention is to examine the effect of a combination of the two bacterial strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic manifestations in small children, and how a combination of BB-12 and LGG affects the immune system, gastrointestinal tract and the… Read more about this study

Who is it for?: Ages 8 to 14 monthsHealthy volunteers can take part
Conditions the study is for: Days Absent From Daycare, Respiratory Tract Infections, Gastrointestinal Infections
What is being tested?: Probiotic (2 * 10^9 cfu/day)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: 1 siteDenmark
Study dates: Aug 2014to Jun 2016
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 8 to 14 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Expected to start daycare between the age of 8-14 month
Intervention start 0 days to 12 weeks before starting daycare
Expected to start daycare from september to february (both month included)
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

Other trials in Denmark

About this study

Conditions: Days Absent From Daycare, Respiratory Tract Infections, Gastrointestinal Infections, Allergy
Being tested: Probiotic (2 * 10^9 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 (2 * 10^9 cfu/day)Dietary supplement
Also called bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, Lactobacillus Rhamnosus GG (LGG), 10^9 cfu/day
Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months
PlaceboDietary supplement
Placebo for 6 months

Study groups in NCT02180581
Study group	Role	What they receive
Probiotic (2 * 10^9 cfu/d)	Experimental	Daily intake of bifidobacterium animalis ssp. Lactis (BB12) and Lactobacillus Rhamnosus GG (LGG) in a dosage of 10^9 cfu/day of each strain. The probiotics are provided as powder in a sachet, and can be added to food or drink Receives: Dietary Supplement: Probiotic (2 * 10^9 cfu/day)
Placebo	Placebo comparator	provided as powder in a sachet, and can be added to food or drink Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of days absent from daycare 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 questionnaires
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 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 ultrasound
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.

Aug 2014Jun 2016

First posted2 Jul 2014 (estimated)
Study startAug 2014
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Days Absent From DaycareStudies 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: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02180581
Sponsor's protocol ID: H-4-2014-032
Other IDs: H-4-2014-032
Acronym: ProbiComp
Status last verified: Aug 2016
First submitted: 30 Jun 2014
Last updated: 24 Aug 2016
Results posted: No
Data monitoring committee: No

Publications

Schmidt RM, Pilmann Laursen R, Bruun S, Larnkjaer A, Molgaard C, Michaelsen KF, Host A. Probiotics in late infancy reduce the incidence of eczema: A randomized controlled trial. Pediatr Allergy Immunol. 2019 May;30(3):335-340. doi: 10.1111/pai.13018. Epub 2019 Feb 21.
PubMed 30790361
Laursen MF, Laursen RP, Larnkjaer A, Michaelsen KF, Bahl MI, Licht TR. Administration of two probiotic strains during early childhood does not affect the endogenous gut microbiota composition despite probiotic proliferation. BMC Microbiol. 2017 Aug 17;17(1):175. doi: 10.1186/s12866-017-1090-7.
PubMed 28818050

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare
ClinicalTrials.gov ID: NCT02180581
Acronym / sponsor ID: ProbiComp / H-4-2014-032
Conditions: Days Absent From Daycare, Respiratory Tract Infections, Gastrointestinal Infections, Allergy
Keywords: Infections, Allergy, Immune function, Microbiota, Infant
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: University of CopenhagenUniversity, hospital or other
Collaborators: The Danish Council for Strategic Research, Novonesis, Technical University of Denmark, University of Bergen, Odense University Hospital, Statens Serum Institut
Study start: Aug 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 2 Jul 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Probiotic (2 * 10^9 cfu/d)	Experimental	Dietary Supplement: Probiotic (2 * 10^9 cfu/day)Daily intake of bifidobacterium animalis ssp. Lactis (BB12) and Lactobacillus Rhamnosus GG (LGG) in a dosage of 10^9 cfu/day of each strain. The probiotics are provided as powder in a sachet, and can be added to food or drink
Placebo	Placebo comparator	Dietary Supplement: Placeboprovided as powder in a sachet, and can be added to food or drink

Who may qualify

Ages: 8 to 14 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Expected to start daycare between the age of 8-14 month
Intervention start 0 days to 12 weeks before starting daycare
Expected to start daycare from september to february (both month included)
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 (2 * 10^9 cfu/day)Also: bifidobacterium animalis ssp. Lactis (BB12), 10^9 cfu/day, Lactobacillus Rhamnosus GG (LGG), 10^9 cfu/dayCombination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months	Dietary supplement	Probiotic (2 * 10^9 cfu/d)
PlaceboPlacebo for 6 months	Dietary supplement	Placebo

Primary outcome

Number of days absent from daycare 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 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 24 Aug 2016.
Derived from this study: PubMed 30790361Schmidt RM, Pilmann Laursen R, Bruun S, Larnkjaer A, Molgaard C, Michaelsen KF, Host A. Probiotics in late infancy reduce the incidence of eczema: A randomized controlled trial. Pediatr Allergy Immunol. 2019 May;30(3):335-340. doi: 10.1111/pai.13018. Epub 2019 Feb 21.
Derived from this study: PubMed 28818050Laursen MF, Laursen RP, Larnkjaer A, Michaelsen KF, Bahl MI, Licht TR. Administration of two probiotic strains during early childhood does not affect the endogenous gut microbiota composition despite probiotic proliferation. BMC Microbiol. 2017 Aug 17;17(1):175. doi: 10.1186/s12866-017-1090-7.

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 (2 * 10^9 cfu/day) in people with Days Absent From Daycare 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 4 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: finished, as of the sponsor's last update on 24 Aug 2016. 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 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?

Number of days absent from daycare 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?

On the ClinicalTrials.gov record for NCT02180581, which also lists 2 linked publications.

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 24 Aug 2016.