Multi-strain Probiotics for NEC

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

2170 Participants Needed

Trial Summary

What is the purpose of this 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?

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Multi-strain Probiotics for NEC?

Research shows that using multi-strain probiotics in premature infants significantly reduces the risk of necrotizing enterocolitis (NEC) and death. In a study, infants receiving these probiotics had lower rates of NEC and mortality compared to those who did not receive them. ^{1 2 3 4 5}

Is the use of multi-strain probiotics safe for humans, particularly in preterm infants?

Research indicates that multi-strain probiotics are generally safe for preterm infants, showing positive effects on reducing gastrointestinal complications, sepsis, and mortality. Studies have not reported significant safety concerns, suggesting that these probiotics can be safely administered to this vulnerable population. ^{4 6 7 8 9}

How is the multi-strain probiotics treatment for NEC different from other treatments?

The multi-strain probiotics treatment for NEC (necrotizing enterocolitis) is unique because it combines several strains of beneficial bacteria, which may offer a broader spectrum of efficacy and potentially synergistic effects compared to single-strain probiotics. This approach aims to enhance the modulation of the gut microbiome, which could be more effective in preventing or treating NEC than using a single strain. ^{10 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Bifidobacterium longum subsp. infantis in experimental necrotizing enterocolitis: alterations in inflammation, innate immune response, and the microbiota. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Mixed probiotics decrease the incidence of stage II-III necrotizing enterocolitis and death: A systematic review and meta-analysis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Probiotics and the mechanism of necrotizing enterocolitis. [2013]

4. Turkey pubmed.ncbi.nlm.nih.gov

The effect of early administration of combined multi-strain and multi-species probiotics on gastrointestinal morbidities and mortality in preterm infants: A randomized controlled trial in a tertiary care unit. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of different probiotic combinations on death and necrotizing enterocolitis in a premature rat model. [2013]

6. Brazil pubmed.ncbi.nlm.nih.gov

A meta-analysis of probiotics for preventing necrotizing enterocolitis in preterm neonates. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Can Enterococcus faecium prevent NEC in preterm infants?: A systematic review and meta-analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Single vs. Two-Strain Probiotic Prophylaxis for Prevention of Necrotizing Enterocolitis in Preterm Infants. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Probiotics for prevention of necrotizing enterocolitis in preterm infants: systematic review and meta-analysis. [2022]

10. Sweden pubmed.ncbi.nlm.nih.gov

Simulating colonic survival of probiotics in single-strain products compared to multi-strain products. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Multistrain Versus Single-strain Probiotics: Current Status and Recommendations for the Future. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Monostrain, multistrain and multispecies probiotics--A comparison of functionality and efficacy. [2006]

13. England pubmed.ncbi.nlm.nih.gov

Treatment with mixed probiotics induced, enhanced and diversified modulation of the gut microbiome of healthy rats. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Single-Strain Probiotics Versus Multi-Strain Mixtures: Systematic Review of Strain and Disease Specificity. [2021]