Trial Profile
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
Status:
Recruiting
Phase of Trial:
Phase III
Latest Information Update: 06 Mar 2024
Price :
$35
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At a glance
- Drugs Limosilactobacillus reuteri (Primary) ; Limosilactobacillus reuteri (Primary)
- Indications Acute enterocolitis
- Focus Registrational; Therapeutic Use
- Acronyms Connection
- Sponsors Infant Bacterial Therapeutics
- 21 Jun 2023 According to an Infant Bacterial Therapeutics media release, company have thus far enrolled more than 1,650 of the planned 2,158 premature babies.
- 21 Jun 2023 According to an Infant Bacterial Therapeutics media release, trial received approval from Data Monitoring Committee (DMC) and recruitment can continue as planned with the approved study protocol. DMC has performed a pre-planned futility safety analysis of data of 1403 babies. The information was submitted for publication, through the agency of the contact persons set out above, at 17:20 CET on June 21, 2023.
- 15 Jun 2023 According to an Infant Bacterial Therapeutics media release, the company announced that the European Patent Office has approved its patent application for Lactobacillus reuteri.