Necrotizing EnterocolitisPhase 3NCT01531179
Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants
A Phase 3 study testing Lactobacillus reuteri in people with Necrotizing Enterocolitis and Very Low Birth Weight Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Necrotizing Enterocolitis, Very Low Birth Weight Infants
- What is being tested?
- Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2012to Feb 2013
- 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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very low birth weight infants < 1500 gr
- Gestational age < 32 weeks
Who cannot join
- Genetic anomalies
- Short bowel syndrome
- Not willing to participate
- Allergy to Lactobacillus reuteri components
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Ankara, Turkey, 06110
About this study
Official title: Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.
- Being tested
- Lactobacillus reuteri, Placebo
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDrug
Also called BioGaia
Lactobacillus reuteri 100 million CFU/day for 3 months
PlaceboDrug
Placebo for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri | Experimental | Lactobacillus reuteri 100 million CFU/day for 3 months Receives: Drug: Lactobacillus reuteri |
| Control | Placebo comparator | Placebo for 3 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.
Measured: up to 6 months
Secondary outcomes (3)
Effect of Lactobacillus reuteri on culture proved sepsis
Patients with culture positivity will accept as proven sepsis.
Measured: up to 6 months
Effect of Lactobacillus reuteri on weight gain
The infants will be weight daily on scales that will calibrated weekly.
Measured: up to 6 months
Effect of Lactobacillus reuteri on length of hospital stay
Specified length of hospital stay as days
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 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 Necrotizing EnterocolitisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yekta, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Mehmet Yekta Oncel, MD, Principal investigator, Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531179
- Sponsor's protocol ID
- ZTB6303
- Status last verified
- Feb 2013
- First submitted
- 4 Feb 2012
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Oncel MY, Sari FN, Arayici S, Guzoglu N, Erdeve O, Uras N, Oguz SS, Dilmen U. Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F110-5. doi: 10.1136/archdischild-2013-304745. Epub 2013 Dec 5.
PubMed 24309022
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role Of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01531179
- Acronym / sponsor ID
- ZTB6303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Feb 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.
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are < 1500 g. Although bifidobacterium and other lactobacilli spp. have been used to reduce the incidence of necrotizing enterocolitis in clinical trials, Lactobacillus reuteri has not been used in the prevention of necrotizing enterocolitis in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered Lactobacillus reuteri in reducing the incidence and severity of necrotizing enterocolitis in very low birth weight infants.
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 |
|---|---|---|
| Lactobacillus reuteri | Experimental | Drug: Lactobacillus reuteriLactobacillus reuteri 100 million CFU/day for 3 months |
| Control | Placebo comparator | Drug: PlaceboPlacebo for 3 months |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Very low birth weight infants < 1500 gr
- Gestational age < 32 weeks
Key exclusion criteria (4 listed)
- Genetic anomalies
- Short bowel syndrome
- Not willing to participate
- Allergy to Lactobacillus reuteri components
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 reuteriAlso: BioGaiaLactobacillus reuteri 100 million CFU/day for 3 months | Drug | Lactobacillus reuteri |
| PlaceboPlacebo for 3 months | Drug | Control |
Primary outcome
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
Time frame: up to 6 months
NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.
3 secondary outcomes
Effect of Lactobacillus reuteri on culture proved sepsis
Time frame: up to 6 months
Effect of Lactobacillus reuteri on weight gain
Time frame: up to 6 months
Effect of Lactobacillus reuteri on length of hospital stay
Time frame: up to 6 months
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 13 May 2013.
- Derived from this study: PubMed 24309022Oncel MY, Sari FN, Arayici S, Guzoglu N, Erdeve O, Uras N, Oguz SS, Dilmen U. Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F110-5. doi: 10.1136/archdischild-2013-304745. Epub 2013 Dec 5.
- Lactobacillus reuteriLink provided by the sponsor.
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Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
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Necrotizing Enterocolitis
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Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
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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.
Mehmet Yekta Oncel, MD principal investigator
Neonatology
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 reuteri in people with Necrotizing Enterocolitis and Very Low Birth Weight Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 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 13 May 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 Turkey (Türkiye). 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?
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants (time frame: up to 6 months). 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 NCT01531179, 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 13 May 2013.