What side effects are associated with this type of intervention?

Common treatments for Necrotizing Enterocolitis (NEC) include antibiotics, surgery, and supportive care. Probiotics, like those being studied in the IBP-9414 trial, are used to modulate gut microbiota and prevent NEC. Known side effects of probiotics can include gastrointestinal symptoms such as gas, bloating, and diarrhea. In rare cases, probiotics may cause infections, particularly in immunocompromised individuals. Overall, probiotics are generally considered safe, but their use should be carefully monitored in vulnerable populations like preterm infants.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved probiotic treatments for Necrotizing Enterocolitis (NEC). The standard management of NEC primarily involves supportive care, including bowel rest, parenteral nutrition, and antibiotics. Surgical intervention may be necessary in severe cases. The IBP-9414 trial is investigating the use of probiotics to modulate gut microbiota as a preventive measure for NEC, which represents a novel approach in the treatment landscape for this condition.

What other types of research exist?

Promising alternatives to IBP-9414 for the prevention of necrotizing enterocolitis in preterm infants include: 1) Probiotics such as Lactobacillus rhamnosus GG and Bifidobacterium breve, which have shown efficacy in reducing NEC incidence. 2) Synbiotics, which combine probiotics and prebiotics, like the combination of Bifidobacterium breve M-16V with galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS). 3) Emerging therapies focusing on gut microbiota modulation and enhancing gut barrier function, though these are still under investigation.

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Protein

IBP-9414 for Necrotizing Enterocolitis

Phase 3

Waitlist Available

Led By Josef Neu, MD

Research Sponsored by Infant Bacterial Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing IBP-9414 to see if it can prevent a serious gut disease in premature babies who weigh between 500 and 1500 grams. The treatment likely helps keep their intestines healthy and reduces infections.

Who is the study for?

This trial is for preterm infants born between 23 and 32 weeks of gestation, weighing 500-1500g, and under 48 hours old. Infants with chromosomal anomalies, enrolled in other trials, critically ill without intensive care options, at high risk for early sepsis, with gastrointestinal diseases or exposed to HIV are excluded.

What is being tested?

The study tests IBP-9414's effectiveness and safety in preventing necrotizing enterocolitis (a serious intestinal disease) in preterm infants compared to a placebo. The goal is to see if this treatment can protect these vulnerable babies from developing the condition.

What are the potential side effects?

While specific side effects of IBP-9414 aren't listed here, common concerns may include reactions at the administration site, digestive issues or imbalances in gut bacteria due to its nature as an intestinal-focused treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: IBP-9414Active Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Probiotics, such as those being studied in the IBP-9414 trial, are a common treatment for Necrotizing Enterocolitis (NEC) that work by modulating the gut microbiota. They enhance the intestinal barrier function and modulate the immune response, which helps prevent the overgrowth of pathogenic bacteria, reduce inflammation, and improve gut integrity. These mechanisms are crucial for preventing NEC in preterm infants, as they address the underlying factors that contribute to the development of this serious condition.

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Who is running the clinical trial?

Infant Bacterial TherapeuticsLead Sponsor

1 Previous Clinical Trials

120 Total Patients Enrolled

Josef Neu, MDPrincipal InvestigatorUniversity of Florida College of Medicine, Gainsville, FL

4 Previous Clinical Trials

281 Total Patients Enrolled

Media Library

IBP-9414 (Protein) Clinical Trial Eligibility Overview. Trial Name: NCT03978000 — Phase 3

Necrotizing Enterocolitis Research Study Groups: Placebo, IBP-9414

Necrotizing Enterocolitis Clinical Trial 2023: IBP-9414 Highlights & Side Effects. Trial Name: NCT03978000 — Phase 3

IBP-9414 (Protein) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03978000 — Phase 3

~345 spots leftby Oct 2025

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