IBP-9414 for Necrotizing Enterocolitis

Not currently recruiting at 97 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called IBP-9414, a new potential drug, to prevent necrotizing enterocolitis, a severe intestinal condition, in preterm infants. The trial compares IBP-9414 to a placebo, a substance with no active treatment, to evaluate its effectiveness and safety. Babies born early, weighing between 500 and 1500 grams, and less than 48 hours old may qualify for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for preterm infants.

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 IBP-9414 is likely to be safe for humans?

Research has shown that IBP-9414 is safe for use in premature babies. Previous studies found no safety problems in these vulnerable infants. One study concluded that IBP-9414 was safe and well-tolerated, meaning the babies did not experience harmful side effects. Researchers are comparing this treatment to a placebo (a substance with no treatment effect) to ensure its safety and effectiveness in preventing necrotizing enterocolitis, a serious intestinal disease in premature infants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for necrotizing enterocolitis, like antibiotics and surgery, focus on managing symptoms and complications. But IBP-9414 is different because it uses a specific strain of probiotics to target the gut's microbiome directly. This novel approach aims to prevent the development of this serious condition by promoting a healthier balance of bacteria in the intestines. Researchers are excited about IBP-9414's potential to not only treat but also prevent necrotizing enterocolitis, offering a proactive solution rather than a reactive one.

What evidence suggests that IBP-9414 might be an effective treatment for necrotizing enterocolitis?

Research shows that IBP-9414 is being tested to prevent necrotizing enterocolitis (NEC), a serious and potentially life-threatening intestinal condition in premature babies. The Connection Study, the largest of its kind, examines the effectiveness and safety of IBP-9414. Participants in this trial receive either IBP-9414 or a placebo. Early results suggest that IBP-9414 might reduce the risk of NEC. Although specific results from this study are not yet available, the emphasis on safety and effectiveness in preventing NEC is promising for IBP-9414. ^{2 3 6 7 8}

Who Is on the Research Team?

Josef Neu, MD

Principal Investigator

University of Florida College of Medicine, Gainsville, FL

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03978000

Study Details | NCT03978000 | IBP-9414 for the Prevention ... IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of ...

2. ibtherapeutics.com ibtherapeutics.com/science/ibp-9414/

IBP-9414 NEC annually kills approximately 3,700 and 1,500 infants annually in Europe and the US, respectively. NEC has an unpredictable, spontaneous, and acute onset and ...

3. clinicaltrial.be clinicaltrial.be/en/details/63259?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

IBP-9414 for the Prevention of Necrotizing Enterocolitis... IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the ...

4. inderes.dk inderes.dk/en/releases/infant-bacterial-therapeutics-ibt-to-present-results-of-the-connection-study-at-espghan-2025-in-helsinki

Infant Bacterial Therapeutics (IBT) to present results of “The ... The Connection Study is the largest randomized, double-blind, parallel-group, placebo-controlled trial to date evaluating the efficacy and safety of IBP-9414 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11688151/

Clinical Characteristics of Necrotizing Enterocolitis Diagnosed ... Sixteen percent of cNEC cases died. Adverse events of NEC were reported in 8.5% of infants and 4.1% had NEC diagnosed by radiology and surgery/autopsy at the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03978000

IBP-9414 for the Prevention of Necrotizing Enterocolitis IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of ...

7. ibtherapeutics.com ibtherapeutics.com/what-is-the-connection-study/

What is the Connection Study This pivotal phase III study investigates the safety characteristics and the effectiveness of IBP-9414 over placebo in the prevention of NEC in preterm infants ...

8. microbiometimes.com microbiometimes.com/ibts-phase-iii-study-shows-a-significant-reduction-in-the-secondary-endpoint-all-cause-mortality-and-continues-the-development-towards-pharmaceutical-registration/

IBT's phase III study shows a significant reduction in ... Furthermore the study shows that giving IBP-9414 to these very vulnerable premature infants does not cause any safety issues, including the risk ...