Gastrointestinal Tract InfectionsPROBIC IINCT01702766
Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children
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 nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission This study is a… Read more about this study
- Who is it for?
- Ages 1 year to 18 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
- Not given
- Where
- 1 siteCroatia
- Study dates
- Dec 2012to Jul 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 18 years
- All sexes
- Child, Adult
Who may be able to join
- Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb
- Age from 1 year to 18 years
- Signed informed consent by the parents
Who cannot join
- Immunodeficiency
- Infants from neonatal period until 1 year of age
- Re-hospitalisation (readmission in a hospital within one month)
- Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization)
- Neoplasms
- Severe chronic diseases
- Hospitalization shorter than 3 days
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission
This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.
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.
The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.
The placebo product is an identical product except for the absence of probiotics.
The study includes an intervention period lasting the length of the hospital stay.
The study product will be consumed daily in the morning together with breakfast.
The consumption of the study products will be taken under the surveillance of the physician.
Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.
- 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 in children
Number of children with common infections (gastrointestinal and respiratory infections):
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.
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 startDec 2012
- Primary completionJul 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
- Intervention model
- Parallel groups
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
- NCT01702766
- Sponsor's protocol ID
- PROBBIC II Study
- Acronym
- PROBIC II
- 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, Tokic Pivac V, Mocic Pavic A, Pasini AM, Kolacek S. Bifidobacterium animalis subsp. lactis fails to prevent common infections in hospitalized children: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2015 Mar;101(3):680-4. doi: 10.3945/ajcn.114.102004. Epub 2015 Jan 7.
PubMed 25733653
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 for Lowering the Risk of Common Infections in Hospitalized Children
- ClinicalTrials.gov ID
- NCT01702766
- Acronym / sponsor ID
- PROBIC II / PROBBIC II Study
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Children's Hospital ZagrebUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 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 nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission
This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.
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.
The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.
The placebo product is an identical product except for the absence of probiotics.
The study includes an intervention period lasting the length of the hospital stay.
The study product will be consumed daily in the morning together with breakfast.
The consumption of the study products will be taken under the surveillance of the physician.
Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- 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 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb
- Age from 1 year to 18 years
- Signed informed consent by the parents
Key exclusion criteria (7 listed)
- Immunodeficiency
- Infants from neonatal period until 1 year of age
- Re-hospitalisation (readmission in a hospital within one month)
- Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization)
- Neoplasms
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 in children
Number of children with common infections (gastrointestinal and respiratory infections): 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. 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 25733653Hojsak I, Tokic Pivac V, Mocic Pavic A, Pasini AM, Kolacek S. Bifidobacterium animalis subsp. lactis fails to prevent common infections in hospitalized children: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2015 Mar;101(3):680-4. doi: 10.3945/ajcn.114.102004. Epub 2015 Jan 7.
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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 3 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 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 in children. 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 NCT01702766, 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.