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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 from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Awards & highlights

Summary

This trial will test a new medication to see if it can prevent a disease called necrotizing enterocolitis in premature babies.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed necrotizing enterocolitis (NEC)
Time to sustained feeding tolerance
Secondary outcome measures
At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication.
Days with clinical signs of feeding intolerance
Death all causes
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IBP-9414Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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.

Find a Location

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
~360 spots leftby Jul 2025