Necrotizing Enterocolitis (NEC)Phase 3NCT06810154
Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
A Phase 3 study testing Multi-strain probiotics in people with Necrotizing Enterocolitis (NEC), run by University of Calgary at 4 sites in Canada.
Trial summary
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation. Read more about this study
- Who is it for?
- Ages 0 to 72 hours
- Conditions the study is for
- Necrotizing Enterocolitis (NEC)
- What is being tested?
- Multi-strain probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,170 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Jun 2025to 30 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 0 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born between <32 0/7 weeks gestation.
Who cannot join
- Major congenital or chromosomal abnormalities
- Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites
Foothills Medical Center
Calgary, Alberta, T2Z 2G9
Belal N Alshaikh, MD, MSc, +1 403 956 1588, balshaik@ucalgary.ca
Royal Alexandra Hospital
Edmonton, Alberta
Kumar Kumaran, MD, 780-735-5179, kumar.kumaran@ahs.ca
IWK
Halifax
Balpreet Singh, MD, 902-470-7055, balpreet.singh@iwk.nshealth.ca
Children's and Women's health of Britch Columbia
Vancouver, British Columbia
Horacio Osiovich, MD, 604- 875-2345, hosiovich@cw.bc.ca
About this study
Official title: Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants: a Stepped-Wedge Cluster Randomized Trial
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation. The main questions it aims to answer are:
- Does the use of a multi-strain probiotic combination reduce the incidence of NEC in preterm infants?
- Are there any adverse effects associated with the administration of this probiotic combination?
Read the detailed description
Researchers will compare outcomes between two phases:
Control Phase: No probiotics will be administered, and outcomes will be recorded to establish baseline NEC rates.
Intervention Phase: Participants will receive a daily multi-strain probiotic combination (0.5 g sachet) starting within 24 hours of enteral feeding initiation.
Participants will be:
- Preterm infants born at <32 weeks' gestation and <1500 g birth weight.
The study uses a stepped-wedge cluster randomized trial (SW-CRT) design, where neonatal intensive care units (NICUs) transition from the control phase to the intervention phase at pre-specified intervals. Individual consent will be obtained for probiotic administration and data collection during the intervention phase, and data collection-only consent will be sought during the control phase.
This trial is designed to provide high-quality evidence on the efficacy and safety of probiotics in preventing NEC in preterm infants.
- Conditions
- Necrotizing Enterocolitis (NEC)
- Being tested
- Multi-strain probiotics
- Keywords
- Probiotics, Necrotizing enteroclitis, preterm infants
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain probioticsBiological
Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Infants will not receive any probiotics. |
| Multi-strain probiotics | Experimental | Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds. Receives: Biological: Multi-strain probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of necrotizing enterocolitis (NEC
NEC defined in CNN according to modified Bell's criteria.
Measured: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Secondary outcomes (4)
Survival
Measured: From date of randomization until the date of 34 weeks corrected gestational age
Late-onset sepsis
Culture proven late onset sepsis
Measured: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Growth anthropometrics at 36 weeks corrected gestation
Z scores of weight and head circumference
Measured: at 36 weeks corrected age or discharge from level III NICU whichever occure first.
Time to achieve full enteral feed
Defined by reaching 140 mL/kg/day sustained for three consecutive days
Measured: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Enterocolitis (NEC)Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Sequential
- Model description
- A Stepped-Wedge Cluster Randomized Trial
- Masking
- None (open label)
- Enrolment
- 2,170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belal Alshaikh, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810154
- Sponsor's protocol ID
- U of Calgary REB24-1960
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants: a Stepped-Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06810154
- Acronym / sponsor ID
- U of Calgary REB24-1960
- Conditions
- Necrotizing Enterocolitis (NEC)
- Keywords
- Probiotics, Necrotizing enteroclitis, preterm infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,170 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 5 Feb 2025 (actual)
- 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.
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation. The main questions it aims to answer are:
- Does the use of a multi-strain probiotic combination reduce the incidence of NEC in preterm infants?
- Are there any adverse effects associated with the administration of this probiotic combination?
Detailed description
Researchers will compare outcomes between two phases:
Control Phase: No probiotics will be administered, and outcomes will be recorded to establish baseline NEC rates.
Intervention Phase: Participants will receive a daily multi-strain probiotic combination (0.5 g sachet) starting within 24 hours of enteral feeding initiation.
Participants will be:
- Preterm infants born at <32 weeks' gestation and <1500 g birth weight.
The study uses a stepped-wedge cluster randomized trial (SW-CRT) design, where neonatal intensive care units (NICUs) transition from the control phase to the intervention phase at pre-specified intervals. Individual consent will be obtained for probiotic administration and data collection during the intervention phase, and data collection-only consent will be sought during the control phase.
This trial is designed to provide high-quality evidence on the efficacy and safety of probiotics in preventing NEC in preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Stepped-Wedge Cluster Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Infants will not receive any probiotics. |
| Multi-strain probiotics | Experimental | Biological: Multi-strain probioticsInfants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds. |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born between <32 0/7 weeks gestation.
Key exclusion criteria (2 listed)
- Major congenital or chromosomal abnormalities
- Conditions affecting gastrointestinal systems that prohibit infants from starting on feed in the first 72 hours after birth.
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 |
|---|---|---|
| Multi-strain probioticsInfants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) with enetral feed. | Biological | Multi-strain probiotics |
Primary outcome
Incidence of necrotizing enterocolitis (NEC
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
NEC defined in CNN according to modified Bell's criteria.
4 secondary outcomes
Survival
Time frame: From date of randomization until the date of 34 weeks corrected gestational age
Late-onset sepsis
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Growth anthropometrics at 36 weeks corrected gestation
Time frame: at 36 weeks corrected age or discharge from level III NICU whichever occure first.
Time to achieve full enteral feed
Time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Multi-strain probiotics in people with Necrotizing Enterocolitis (NEC), run by University of Calgary at 4 sites in Canada.
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 2 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: opening soon, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Belal N Alshaikh, MD, MSc (+1 403 956 1588, balshaik@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of necrotizing enterocolitis (NEC (time frame: From date of randomization until the date of 34 weeks corrected gestational age or or date of death from any cause, whichever came first). 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 5 Feb 2025.