Multi-strain Probiotics for NEC

Not yet recruiting at 3 trial locations

Overseen By Belal N Alshaikh, MD, MSc

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Calgary

Disqualifiers: Congenital abnormalities, Gastrointestinal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mix of probiotics, specifically strains of lactobacillus and bifidobacterium, can prevent necrotizing enterocolitis (NEC) in preterm infants. NEC affects the intestines of babies born too early. The study aims to determine if the probiotics can reduce the risk of NEC and identify any side effects. Infants born before 32 weeks of pregnancy who can begin feeding within the first 72 hours after birth may qualify for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that probiotics with multiple strains, such as those containing lactobacillus and bifidobacterium, are generally safe for premature babies. Studies have found that these probiotics can help prevent necrotizing enterocolitis (NEC), a serious intestinal condition, and improve feeding tolerance in premature infants. They are considered both safe and effective for these purposes.

Additionally, several reviews indicate that probiotics not only lower the risk of NEC but also reduce the overall mortality rate in infants. This suggests that the benefits of probiotics outweigh the risks. While no treatment is completely risk-free, current evidence indicates that these probiotics are well-tolerated and do not present major safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for necrotizing enterocolitis (NEC) focus on supportive care, like antibiotics and surgery, to manage symptoms and complications. However, multi-strain probiotics represent a novel approach by using beneficial bacteria, specifically Bifidobacterium and Lacticaseibacillus, to potentially prevent or reduce the severity of NEC. Researchers are excited about these probiotics because they aim to restore a healthy gut microbiome, which could enhance gut health and immunity in infants. This treatment works differently by proactively balancing gut bacteria rather than just treating symptoms, which could lead to better outcomes for vulnerable infants.

What evidence suggests that multi-strain probiotics might be an effective treatment for NEC?

Research shows that probiotics with multiple strains, such as lactobacillus and bifidobacterium, can help prevent necrotizing enterocolitis (NEC), a serious gut condition in premature babies. Studies have found that these probiotics lower the risk of NEC and related deaths. Using multiple strains appears more effective, with one study showing a significant drop in death rates. In this trial, some infants will receive multi-strain probiotics, which are believed to improve gut health and may protect against NEC. Overall, evidence supports the idea that these probiotics can reduce the risk of NEC in vulnerable infants. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for very preterm infants born at less than 32 weeks of gestation. It's designed to see if multi-strain probiotics can prevent a serious intestinal condition called necrotizing enterocolitis (NEC).

Inclusion Criteria

My baby was born before 32 weeks of pregnancy.

Exclusion Criteria

My infant couldn't start feeding within 72 hours after birth due to a gastrointestinal condition.

I have a significant birth defect or genetic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Control Phase

No probiotics will be administered, and outcomes will be recorded to establish baseline NEC rates

Varies by NICU transition schedule

Intervention Phase

Participants will receive a daily multi-strain probiotic combination starting within 24 hours of enteral feeding initiation

Until 34 weeks corrected gestational age or discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

Until 36 weeks corrected gestational age or discharge

What Are the Treatments Tested in This Trial?

Interventions

• Multi-strain Probiotics

Trial Overview The study tests whether giving a combination of lactobacillus and bifidobacterium probiotics to these infants can reduce the risk of developing NEC.

How Is the Trial Designed?

Group I: Multi-strain probiotics Experimental Treatment 1 Intervention

Infants will be started on probiotics (Bifidobacterium and Lacticaseibacillus) within 24 hours of commencing enteral feeds.

Group II: Control Active Control 1 Intervention

Infants will not receive any probiotics.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11987312/

The effectiveness of treatment with probiotics in preventing ... The present review suggests that supplementation with probiotics reduced NEC and related mortality. Probiotic supplementation can be recognized ...

2. cureus.com cureus.com/articles/418505-effect-of-probiotic-supplementation-in-preventing-necrotizing-enterocolitis-sepsis-and-mortality-among-preterm-and-very-low-birth-weight-infants-a-systematic-review-and-meta-analysis.pdf?email=

Effect of Probiotic Supplementation in Preventing ... Primary outcomes assessed were NEC, sepsis, and mortality, while secondary outcomes included feeding tolerance, hospital stay, and inflammatory ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0171579

Multiple strains probiotics appear to be the most effective ... Multiple strains probiotics had a greater effectiveness in reducing mortality and were associated with a pooled OR of 0.58 (95% CI, 0.43–0.79; P = .0006).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06810154

Study Details | NCT06810154 | Multi-strain Probiotics to ... The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1744165X25000629

does it prevent or cause neonatal sepsis? Multiple systematic reviews and meta-analyses consistently show that probiotics reduce necrotising enterocolitis (NEC) incidence and all-cause ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9415863/

Effect of a Multi-Strain Probiotic on the Incidence and ... Conclusion: A multi-strain probiotic is a safe and cost-effective way of preventing NEC and feeding intolerances in premature neonates. Keywords ...