IBP-9414 for Necrotizing Enterocolitis

Recruiting at 90 trial locations

Overseen By Anders Kronström

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Infant Bacterial Therapeutics

Disqualifiers: Sepsis, Chromosomal anomalies, HIV, others

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

Duration: 6 weeks

2158 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

Research Team

Josef Neu, MD

Principal Investigator

University of Florida College of Medicine, Gainsville, FL

Eligibility Criteria

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.

Inclusion Criteria

Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days

≤ 48 hours of age

Written informed consent from the subject´s legally authorized representative (LAR)

Exclusion Criteria

Infants with recognized chromosomal anomalies

Participation in any other interventional clinical trial

Infants in extremis to whom no further intensive care is offered by attending neonatologist

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IBP-9414 or placebo to evaluate efficacy and safety in the prevention of necrotizing enterocolitis

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• IBP-9414

Trial Overview 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.

Participant Groups

Group I: IBP-9414 Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Infant Bacterial Therapeutics

Lead Sponsor

Trials

2

Recruited

2,300+