IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

• ClinicalTrials.gov Identifier: NCT03978000
• Recruitment Status: Recruiting
• First Posted: June 6, 2019
• Last Update Posted: March 9, 2022
• Sponsor: Infant Bacterial Therapeutics
• Information provided by (Responsible Party): Infant Bacterial Therapeutics

Tracking Information

• First Submitted Date: June 5, 2019
• First Posted Date: June 6, 2019
• Last Update Posted Date: March 9, 2022
• Actual Study Start Date: July 4, 2019
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2019)

• Confirmed necrotizing enterocolitis (NEC) [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
• Time to sustained feeding tolerance [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 5, 2019)

• 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. [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
• Surgery (or autopsy) with confirmation of NEC [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
• Death all causes [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
• Number of days of hospitalization [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
• Weight gain in g/kg [ Time Frame: Weeks 3 and 4 of age ]
• Number of subjects growing at ≥100 g/kg/week [ Time Frame: Weeks 3 and 4 of age ]
• Days with clinical signs of feeding intolerance [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
• Official Title: A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study
• Brief Summary: 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 necrotizing enterocolitis.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Necrotizing Enterocolitis

Intervention

• Drug: IBP-9414
  Oral suspension
• Drug: Placebo
  Sterile water

Study Arms

• Active Comparator: IBP-9414
  Intervention: Drug: IBP-9414
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 5, 2019): 2158
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
• Birth weight 500-1500g
• ≤ 48 hours of age
• Written informed consent from the subject´s legally authorized representative (LAR)

Exclusion Criteria:

• Participation in any other interventional clinical trial
• Infants in extremis to whom no further intensive care is offered by attending neonatologist
• Infants with, or at a high probability for, early onset sepsis
• Infants with recognized chromosomal anomalies
• Congenital or acquired gastrointestinal disease
• Earlier or planned administration of formulas, foods or supplements that contain added live bacteria
• Infants with known positive maternal HIV status

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 48 Hours (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Anders Kronström; +46841014555; clinical@ibtherapeutics.com

• Listed Location Countries: Bulgaria, France, Hungary, Israel, Poland, Romania, Serbia, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03978000
• Other Study ID Numbers: IBP-9414-020
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Infant Bacterial Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Infant Bacterial Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Josef Neu, MD; University of Florida College of Medicine, Gainsville, FL

• PRS Account: Infant Bacterial Therapeutics
• Verification Date: March 2022