Gastrointestinal Tract InfectionsPROBBICNCT01702753
Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers
A study testing Bifidobacterium animalis subsp. lactis in people with Gastrointestinal Tract Infections and Respiratory Tract Infections, run by Children's Hospital Zagreb at 1 site in Croatia.
Trial summary
Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Gastrointestinal Tract Infections, Respiratory Tract Infections
- What is being tested?
- Bifidobacterium animalis subsp. lactis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteCroatia
- Study dates
- Jan 2013to 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 1 year to 7 years
- All sexes
- Child
Who may be able to join
- Healthy children attending day care at kindergartens located in the Zagreb's city centre
- Age from 1 year to 7 years
- Attendance at daycare centers: > 3 days per week
- Signed informed consent by the parents
Who cannot join
- Immunodeficiency
- Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start)
- Neoplasms
- Severe chronic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study
Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre
This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers.
Read more
The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections and absence from day care due to infections.
The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics.
The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal.
The consumption of the study products will be taken under the surveillance of the parents.
During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel.
Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log).
All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's \& physician's).
- Being tested
- Bifidobacterium animalis subsp. lactis
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium animalis subsp. lactisDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium animalis subsp. lactis | Active comparator | Not described Receives: Dietary Supplement: Bifidobacterium animalis subsp. lactis |
| Placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common infections
Number of children with gastrointestinal tract infections defined as diarrhoea (3 or more loose or watery stools in 24 hours or increase of number of stools for more than 50% in 24 hours) or vomiting (defined by physician and not a result of other symptoms including cough or diseases including gastroesophageal reflux disease or neurological conditions) or both.
And number of children with respiratory tract infections defined as: pharyngitis, otitis, common cold, pneumonia, bronchitis and bronciolitis (all infections diagnosed by physician) Number of children with adverse events.
Secondary outcomes (1)
Duration of symptoms
Duration of symptoms in days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study startJan 2013
- 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 Gastrointestinal Tract InfectionsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702753
- Sponsor's protocol ID
- PROBBIC I Study
- Acronym
- PROBBIC
- Status last verified
- Jul 2013
- First submitted
- 3 Oct 2012
- Last updated
- 26 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hojsak I, Mocic Pavic A, Kos T, Dumancic J, Kolacek S. Bifidobacterium animalis subsp. lactis in prevention of common infections in healthy children attending day care centers - Randomized, double blind, placebo-controlled study. Clin Nutr. 2016 Jun;35(3):587-91. doi: 10.1016/j.clnu.2015.05.004. Epub 2015 May 19.
PubMed 26031908
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01702753
- Acronym / sponsor ID
- PROBBIC / PROBBIC I Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Children's Hospital ZagrebUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Oct 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.
Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre
This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers.
The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections and absence from day care due to infections.
The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics.
The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal.
The consumption of the study products will be taken under the surveillance of the parents.
During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel.
Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log).
All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's \& physician's).
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 |
|---|---|---|
| Bifidobacterium animalis subsp. lactis | Active comparator | Dietary Supplement: Bifidobacterium animalis subsp. lactis |
| Placebo | Placebo comparator | – |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children attending day care at kindergartens located in the Zagreb's city centre
- Age from 1 year to 7 years
- Attendance at daycare centers: > 3 days per week
- Signed informed consent by the parents
Key exclusion criteria (4 listed)
- Immunodeficiency
- Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start)
- Neoplasms
- Severe chronic disorders
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 |
|---|---|---|
| Bifidobacterium animalis subsp. lactis | Dietary supplement | Bifidobacterium animalis subsp. lactis |
Primary outcome
Common infections
Number of children with gastrointestinal tract infections defined as diarrhoea (3 or more loose or watery stools in 24 hours or increase of number of stools for more than 50% in 24 hours) or vomiting (defined by physician and not a result of other symptoms including cough or diseases including gastroesophageal reflux disease or neurological conditions) or both. And number of children with respiratory tract infections defined as: pharyngitis, otitis, common cold, pneumonia, bronchitis and bronciolitis (all infections diagnosed by physician) Number of children with adverse events.
1 secondary outcome
Duration of symptoms
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 26 Jul 2013.
- Derived from this study: PubMed 26031908Hojsak I, Mocic Pavic A, Kos T, Dumancic J, Kolacek S. Bifidobacterium animalis subsp. lactis in prevention of common infections in healthy children attending day care centers - Randomized, double blind, placebo-controlled study. Clin Nutr. 2016 Jun;35(3):587-91. doi: 10.1016/j.clnu.2015.05.004. Epub 2015 May 19.
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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.
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 Bifidobacterium animalis subsp. lactis in people with Gastrointestinal Tract Infections and Respiratory Tract Infections, run by Children's Hospital Zagreb at 1 site in Croatia.
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 4 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 26 Jul 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 Croatia. 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?
Common infections. 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 NCT01702753, 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 26 Jul 2013.