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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03978000
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Infant Bacterial Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Drug: IBP-9414 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 4, 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: IBP-9414 Drug: IBP-9414
Oral suspension
Placebo Comparator: Placebo Drug: Placebo
Sterile water


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

Secondary Outcome Measures :
  1. 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 ]
  2. Surgery (or autopsy) with confirmation of NEC [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
  3. Death all causes [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
  4. Number of days of hospitalization [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]
  5. Weight gain in g/kg [ Time Frame: Weeks 3 and 4 of age ]
  6. Number of subjects growing at ≥100 g/kg/week [ Time Frame: Weeks 3 and 4 of age ]
  7. Days with clinical signs of feeding intolerance [ Time Frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age ]

Eligibility Criteria
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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978000


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

Locations
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Sponsors and Collaborators
Infant Bacterial Therapeutics
Investigators
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Principal Investigator: Josef Neu, MD University of Florida College of Medicine, Gainsville, FL
More Information
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Responsible Party: Infant Bacterial Therapeutics
ClinicalTrials.gov Identifier: NCT03978000    
Other Study ID Numbers: IBP-9414-020
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases