Nosocomial InfectionPhase 3NCT02558192
Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children
A Phase 3 study testing Lactobacillus Rhamnosus GG in people with Nosocomial Infection, run by Federico II University at 1 site in Italy.
Trial summary
Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Nosocomial Infection
- What is being tested?
- Lactobacillus Rhamnosus GG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jun 2015
- Phase
- Phase 3
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females between the ages of 3 months and 5 years
- Children admitted to a pediatric ward
Who cannot join
- Children with chronic diseases of the respiratory , gastrointestinal , renal system;
- Children with malformations of the cardiovascular system ;
- Children with immune deficiencies ;
- Infants born preterm ( gestational age < 37 weeks ) ;
- Children with congenital metabolic diseases ;
- Children Who received probiotics before enrollment ( up to 7 days before hospitalization)
Trial locations and contacts
1 site in 1 country.
About this study
Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.
- Conditions
- Nosocomial Infection
- Being tested
- Lactobacillus Rhamnosus GG, PLACEBO
- Keywords
- LGG, Probiotics, nosocomial infection prevention, pediatrics
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Rhamnosus GGDietary supplement
Also called LGG
1 vials q12 for 15 days
PLACEBODietary supplement
1 vials q12 for 15 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Vials containing 3 x 10^9 Colony Forming Units of LGG, vitamins ( B and C) and zinc Receives: Dietary Supplement: Lactobacillus Rhamnosus GG |
| Placebo | Placebo comparator | Vials containing water, maltodextrin, magnesium stearate, potassium sorbate, sodium benzoate, citric acid, fructose, flavor. Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the incidence of nosocomial gastrointestinal infection
Measured: After 15 days of treatment
Study the incidence of nosocomial URTI
Measured: After 15 days of treatment
Secondary outcomes (2)
Days of hospitalization
Measured: After 3 months from the enrollment
The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period
Measured: After 3 months from the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Guarino, Federico II University
- Investigators
- Alfredo Guarino, MD, Principal investigator, Univesità degli Studi di Napoli "Federico II"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558192
- Sponsor's protocol ID
- IN001
- Status last verified
- Sep 2015
- First submitted
- 13 Apr 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hojsak I, Abdovic S, Szajewska H, Milosevic M, Krznaric Z, Kolacek S. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics. 2010 May;125(5):e1171-7. doi: 10.1542/peds.2009-2568. Epub 2010 Apr 19.
PubMed 20403940Guarner F, Bourdet-Sicard R, Brandtzaeg P, Gill HS, McGuirk P, van Eden W, Versalovic J, Weinstock JV, Rook GA. Mechanisms of disease: the hygiene hypothesis revisited. Nat Clin Pract Gastroenterol Hepatol. 2006 May;3(5):275-84. doi: 10.1038/ncpgasthep0471.
PubMed 16673007Packey CD, Sartor RB. Interplay of commensal and pathogenic bacteria, genetic mutations, and immunoregulatory defects in the pathogenesis of inflammatory bowel diseases. J Intern Med. 2008 Jun;263(6):597-606. doi: 10.1111/j.1365-2796.2008.01962.x.
PubMed 18479259Macpherson AJ, Harris NL. Interactions between commensal intestinal bacteria and the immune system. Nat Rev Immunol. 2004 Jun;4(6):478-85. doi: 10.1038/nri1373. No abstract available.
PubMed 15173836Mazmanian SK, Kasper DL. The love-hate relationship between bacterial polysaccharides and the host immune system. Nat Rev Immunol. 2006 Nov;6(11):849-58. doi: 10.1038/nri1956. Epub 2006 Oct 6.
PubMed 17024229Brooks WA, Santosham M, Naheed A, Goswami D, Wahed MA, Diener-West M, Faruque AS, Black RE. Effect of weekly zinc supplements on incidence of pneumonia and diarrhoea in children younger than 2 years in an urban, low-income population in Bangladesh: randomised controlled trial. Lancet. 2005 Sep 17-23;366(9490):999-1004. doi: 10.1016/S0140-6736(05)67109-7.
PubMed 16168782Sazawal S, Black RE, Bhan MK, Bhandari N, Sinha A, Jalla S. Zinc supplementation in young children with acute diarrhea in India. N Engl J Med. 1995 Sep 28;333(13):839-44. doi: 10.1056/NEJM199509283331304.
PubMed 7651474
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children
- ClinicalTrials.gov ID
- NCT02558192
- Acronym / sponsor ID
- IN001
- Conditions
- Nosocomial Infection
- Keywords
- LGG, Probiotics, nosocomial infection prevention, pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Sep 2015 (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.
Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Lactobacillus Rhamnosus GGVials containing 3 x 10^9 Colony Forming Units of LGG, vitamins ( B and C) and zinc |
| Placebo | Placebo comparator | Dietary Supplement: PLACEBOVials containing water, maltodextrin, magnesium stearate, potassium sorbate, sodium benzoate, citric acid, fructose, flavor. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Males and females between the ages of 3 months and 5 years
- Children admitted to a pediatric ward
Key exclusion criteria (6 listed)
- Children with chronic diseases of the respiratory , gastrointestinal , renal system;
- Children with malformations of the cardiovascular system ;
- Children with immune deficiencies ;
- Infants born preterm ( gestational age < 37 weeks ) ;
- Children with congenital metabolic diseases ;
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 |
|---|---|---|
| Lactobacillus Rhamnosus GGAlso: LGG1 vials q12 for 15 days | Dietary supplement | Probiotics |
| PLACEBO1 vials q12 for 15 days | Dietary supplement | Placebo |
Primary outcome
Study the incidence of nosocomial gastrointestinal infection
Time frame: After 15 days of treatment
Study the incidence of nosocomial URTI
Time frame: After 15 days of treatment
2 secondary outcomes
Days of hospitalization
Time frame: After 3 months from the enrollment
The incidence of gastrointestinal and respiratory infection during the 3 month follow-up period
Time frame: After 3 months from the treatment
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 Sep 2015.
- Background: PubMed 20403940Hojsak I, Abdovic S, Szajewska H, Milosevic M, Krznaric Z, Kolacek S. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics. 2010 May;125(5):e1171-7. doi: 10.1542/peds.2009-2568. Epub 2010 Apr 19.
- Background: PubMed 16673007Guarner F, Bourdet-Sicard R, Brandtzaeg P, Gill HS, McGuirk P, van Eden W, Versalovic J, Weinstock JV, Rook GA. Mechanisms of disease: the hygiene hypothesis revisited. Nat Clin Pract Gastroenterol Hepatol. 2006 May;3(5):275-84. doi: 10.1038/ncpgasthep0471.
- Background: PubMed 18479259Packey CD, Sartor RB. Interplay of commensal and pathogenic bacteria, genetic mutations, and immunoregulatory defects in the pathogenesis of inflammatory bowel diseases. J Intern Med. 2008 Jun;263(6):597-606. doi: 10.1111/j.1365-2796.2008.01962.x.
- Background: PubMed 15173836Macpherson AJ, Harris NL. Interactions between commensal intestinal bacteria and the immune system. Nat Rev Immunol. 2004 Jun;4(6):478-85. doi: 10.1038/nri1373. No abstract available.
- Background: PubMed 17024229Mazmanian SK, Kasper DL. The love-hate relationship between bacterial polysaccharides and the host immune system. Nat Rev Immunol. 2006 Nov;6(11):849-58. doi: 10.1038/nri1956. Epub 2006 Oct 6.
- Background: PubMed 16168782Brooks WA, Santosham M, Naheed A, Goswami D, Wahed MA, Diener-West M, Faruque AS, Black RE. Effect of weekly zinc supplements on incidence of pneumonia and diarrhoea in children younger than 2 years in an urban, low-income population in Bangladesh: randomised controlled trial. Lancet. 2005 Sep 17-23;366(9490):999-1004. doi: 10.1016/S0140-6736(05)67109-7.
- Background: PubMed 7651474Sazawal S, Black RE, Bhan MK, Bhandari N, Sinha A, Jalla S. Zinc supplementation in young children with acute diarrhea in India. N Engl J Med. 1995 Sep 28;333(13):839-44. doi: 10.1056/NEJM199509283331304.
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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.
Alfredo Guarino, MD principal investigator
Univesità degli Studi di Napoli "Federico II"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus Rhamnosus GG in people with Nosocomial Infection, run by Federico II University at 1 site in Italy.
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 2 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 23 Sep 2015. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Study the incidence of nosocomial gastrointestinal infection (time frame: After 15 days of treatment). The study lists 2 primary outcomes in all. 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 NCT02558192, which also lists 7 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 23 Sep 2015.