Infant, Premature, DiseasesNCT01891604
Study the Safety and Efficacy of Probiotics Use in Premature Infants
A study testing breast milk with Bifidobacterium Longum subp. Infantis R0033 and breast milk in people with Infant, Premature, Diseases, run by University of Manitoba.
Trial summary
Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity. Read more about this study
- Who is it for?
- Ages Up to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- breast milk with Bifidobacterium Longum subp. Infantis R0033 and breast milk
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2016
- 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 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- born with weight<1500 g
- hospitalized within 48 hours after birth
Who cannot join
- present with evidence or suspicion of congenital intestinal obstruction
- perforation
- gastroschisis
- large omphalocele
- congenital diaphragmatic hernia
- major congenital heart defects
About this study
Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.
- Conditions
- Infant, Premature, Diseases
- Being tested
- breast milk with Bifidobacterium Longum subp. Infantis R0033, breast milk
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast milk with Bifidobacterium Longum subp. Infantis R0033Dietary supplement
breast milkDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Calprotectin will be used to determine the effect for probiotics
Measured: day1 and day30 of the observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Primary completionDec 2016 (estimated)
Why it stopped: Study Never Initiated due to Impact approval from institution not being obtinaed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Principal investigator, Dr. James Friel, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891604
- Sponsor's protocol ID
- jamesfriel2013
- Status last verified
- May 2017
- First submitted
- 26 Jun 2013
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Safety and Efficacy of Probiotics Use in Premature Infants
- ClinicalTrials.gov ID
- NCT01891604
- Acronym / sponsor ID
- jamesfriel2013
- Conditions
- Infant, Premature, Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study Never Initiated due to Impact approval from institution not being obtinaed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Primary completion
- Dec 2016 (estimated)
- First posted
- 3 Jul 2013 (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.
Prophylactic enteral probiotics may enhance clinical markers and biomarkers of preterm infants' health, and may also play a role in reducing NEC and associated morbidity.
Study design
- Intervention model
- Parallel groups
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- born with weight<1500 g
- hospitalized within 48 hours after birth
Key exclusion criteria (6 listed)
- present with evidence or suspicion of congenital intestinal obstruction
- perforation
- gastroschisis
- large omphalocele
- congenital diaphragmatic hernia
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 |
|---|---|---|
| breast milk with Bifidobacterium Longum subp. Infantis R0033 | Dietary supplement | – |
| breast milk | Dietary supplement | – |
Primary outcome
Calprotectin will be used to determine the effect for probiotics
Time frame: day1 and day30 of the observation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing breast milk with Bifidobacterium Longum subp. Infantis R0033 and breast milk in people with Infant, Premature, Diseases, run by University of Manitoba.
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: withdrawn, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 withdrawn before enrolling participants, so there are no results.
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?
Calprotectin will be used to determine the effect for probiotics (time frame: day1 and day30 of the observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.