Premature Infant DiseaseReuteriNCT01181791
Effects of Lactobacillus Reuteri in Premature Infants
A study testing Lactobacillus reuteri in people with Premature Infant Disease, run by University of Miami at 2 sites in Chile.
Trial summary
This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Premature Infant Disease
- What is being tested?
- Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesChile
- Study dates
- Jul 2010to Jul 2017
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days
Who cannot join
- Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
- Parental refusal
- Prior enrollment into a conflicting clinical trial
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Sotero del Rio
Santiago
Pontifica Universidad Catolica
Santiago
About this study
Official title: Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.
The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.
Read the detailed description
The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live
- Conditions
- Premature Infant Disease
- Being tested
- Lactobacillus reuteri, Placebo
- Keywords
- probiotics, premature infants, feeding tolerance
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day
PlaceboOther
The placebo consists of an identical formulation except that the L. reuteri is not present.
| Study group | Role | What they receive |
|---|---|---|
| probiotic group | Experimental | Lactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day Receives: Dietary Supplement: Lactobacillus reuteri |
| Placebo | Placebo comparator | The placebo consists of an identical formulation except that the L. reuteri is not present. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach full feeds
Days to reach full feeds from the day feeds are started
Measured: First 40 days after birth
Secondary outcomes (2)
Intestinal colonization
PCR quantification of lactobacillus reuteri in the stools
Measured: 0-6 months after birth
Intestinal immunological response
Quantification immunological markers in the stools
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: Poor recruitment
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 Premature Infant DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Model description
- Administration of probiotic Lactobacillus Reuteri
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile
- Responsible party
- Principal investigator, Teresa del Moral, University of Miami
- Investigators
- Teresa del Moral, MD, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181791
- Sponsor's protocol ID
- 20090924
- Acronym
- Reuteri
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2010
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.
PubMed 37493095Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
PubMed 33058137
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Effects of Lactobacillus Reuteri in Preterm Newborns
- ClinicalTrials.gov ID
- NCT01181791
- Acronym / sponsor ID
- Reuteri / 20090924
- Conditions
- Premature Infant Disease
- Keywords
- probiotics, premature infants, feeding tolerance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile
- Study start
- Jul 2010
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Aug 2010 (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.
This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants.
The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.
Detailed description
The primary outcome "days to achieve full feeds" will be measure during the the first month of life Secondary outcomes will be measured at baseline (before intervention), 3 weeks after intervention, once intervention discontinued and at 6 months of live
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Administration of probiotic Lactobacillus Reuteri
| Arm | Type | Receives |
|---|---|---|
| probiotic group | Experimental | Dietary Supplement: Lactobacillus reuteriLactobacillus reuteri will be given at a dose of 1x108 colony forming units (CFU)/day |
| Placebo | Placebo comparator | Other: PlaceboThe placebo consists of an identical formulation except that the L. reuteri is not present. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm newborns admitted to the neonatal intensive care units with a birth weight 700-1500 g and who survive more than 3 days
Key exclusion criteria (5 listed)
- Chromosomal anomalies.
- Major congenital anomalies (complex cardiac anomalies, congenital hydrocephalus, renal dysplasia)
- Congenital (e.g. jejunal atresia) and acquired (e.g. GI perforation) gastrointestinal pathology precluding oral feed and/or requiring major surgical or medical intervention
- Parental refusal
- Prior enrollment into a conflicting clinical trial
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 reuteriLactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day | Dietary supplement | probiotic group |
| PlaceboThe placebo consists of an identical formulation except that the L. reuteri is not present. | Other | Placebo |
Primary outcome
Time to reach full feeds
Time frame: First 40 days after birth
Days to reach full feeds from the day feeds are started
2 secondary outcomes
Intestinal colonization
Time frame: 0-6 months after birth
Intestinal immunological response
Time frame: 0-6 months
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Derived from this study: PubMed 37493095Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.
- Derived from this study: PubMed 33058137Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
- Individual participant dataSharing planned: No
Related trials for Premature Infant Disease
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Teresa del Moral, MD, MPH principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri in people with Premature Infant Disease, run by University of Miami at 2 sites in Chile.
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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
Time to reach full feeds (time frame: First 40 days after birth). 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 NCT01181791, 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 28 Aug 2017.