Necrotizing EnterocolitisPhase 3NCT03978000
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
A Phase 3 study testing IBP-9414 in people with Necrotizing Enterocolitis, run by Infant Bacterial Therapeutics at 89 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- IBP-9414
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,158 participants
- Where
- 89 sitesin 10 countries
- Study dates
- 4 Jul 2019to Jul 2024
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
89 sites in 10 countries.
89 sites in 10 countries
United States54 sites
C.S Mott Children'S Hospital
Ann Arbor, Michigan, 48109
Georgia Regents University
Augusta, Georgia, 30912
St David'S Health Care - St. David'S Medical Center/North Austin Medical Center
Austin, Texas, 78705
Tufts Children's Hospital
Boston, Massachusetts, 02111
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, 02215
Kings County Hospital Center
Brooklyn, New York, 11203
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Children'S Hospital of the University of Illinois
Chicago, Illinois, 60612
St. Francis Medical Center
Colorado Springs, Colorado, 80923
Geisinger Health
Danville, Pennsylvania, 17822
Children's Hospital of Michigan
Detroit, Michigan, 48201
Duke University
Durham, North Carolina, 27705
North Shore University Health System
Evanston, Illinois, 60201
University of Florida Health
Gainesville, Florida, 32610
University of Texas Medical Branch - Ocr
Galveston, Texas, 77555
Helen DeVos Children's Hospital Spectrum Health Research
Grand Rapids, Michigan, 49503
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Connecticut Children'S Medical Center - Uconn - School of Medicine
Hartford, Connecticut, 06106
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jackson Madison County General Hospital
Jackson, Tennessee, 38301
Wolfson Children'S Hospital
Jacksonville, Florida, 32207
Uf Health Jacksonville
Jacksonville, Florida, 32209
Arkansas Children'S Hospital
Little Rock, Arkansas, 72205
University of Arkansas For Medical Services
Little Rock, Arkansas, 72205
Loma Linda University Children Hospital
Loma Linda, California, 11234
Good Samaritan Hospital
Los Angeles, California, 90017
LAC & USC Medical Center
Los Angeles, California, 90033
University of Califorina, Los Angeles (UCLA)
Los Angeles, California, 90095
Valley Childrens Hospital
Madera, California, 93636
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
University of Miami/Holtz Children'S Hospital
Miami, Florida, 33136
Children'S Minnesota
Minneapolis, Minnesota, 55404
West Virginia University Medical Center
Morgantown, West Virginia, 26506
Cohen Children'S Medical Center of Ny
New Hyde Park, New York, 11040
Northwell Health Cohen Children'S Medical Center of Ny
New York, New York, 11040
Children'S Hospital At Ou Medicine
Oklahoma City, Oklahoma, 73104
Texas Health Presbyterian Hospital - Plano
Plano, Texas, 75024
Sheridan Healthcare of Texas, P.A./Medical City Plano
Plano, Texas, 75075-6199
Sheridan Clinical Research / Plantation General Hospital
Plantation, Florida, 33323
Children's Hospital of Richmind at VCU
Richmond, Virginia, 23298
Associates in Newborn Medicine - Saint Paul
Saint Paul, Minnesota, 55102
North Central Baptist Hospital
San Antonio, Texas, 78258
Sharp Memorial Hospital
San Diego, California, 92123
Memorial Hospital of South Bend
South Bend, Indiana, 46601
SIU School of Medicine - HSHS St. John's Children's Hospital
Springfield, Illinois, 62769
Baystate Medical Center
Springfield, Massachusetts, 01199
University of South Florida
Tampa, Florida, 33606
St. Joseph'S Women'S Hospital
Tampa, Florida, 33607
Children'S Hospital At Montefiore
The Bronx, New York, 10461
Banner University Medical Center / University of Arizona
Tucson, Arizona, 85724
Maria Fareri Children's Hospital - Westchester Medical Center
Valhalla, New York, 10595
Wesley Medical Center
Wichita, Kansas, 67214
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Wake Health Forest Baptist Health
Winston-Salem, North Carolina, 27012
Hungary7 sites
University of Debrecen Clinical Center
Debrecen, 4032
Bács-Kiskun County Hospital
Kecskemét, 6000
Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital
Miskolc
Szszb County Hospital and Jósa András University Teaching Hospital
Nyíregyháza, 4400
University of Szeged, Albert Szent-Györgyi Health Centre
Szeged
Szent György University Teaching Hospital of County Fejér
Székesfehérvár, 8000
Veszprém County Csolnoky Ferenc Hospital
Veszprém
Bulgaria5 sites
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology
Pleven
University Multiprofile Hospital for Active Treatment
Plovdiv
Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)
Sofia
Specialized Hospital in Active Treatment of Pediatric Diseases
Sofia
University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic
Sofia
Romania5 sites
Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"
Bucharest
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca
Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi
Iași
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
Timișoara
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara
Spain5 sites
Hospital General de Alicante
Alicante
Hospital Clinico San Carlos - Idissc
Madrid
Hospital Universitario Hm Puerta Del Sur
Madrid
Hospital Juan XXIII
Tarragona
Hospital Universitario La Fe
Valencia
Poland4 sites
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
Szczecin
Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University
Szczecin
Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego
Warsaw
Uniwersytecki Szpital Kliniczny
Wroclaw
France3 sites
Chu Amiens-Picardie - Site Sud
Amiens
Centre Hospitalier Universitaire de Caen Normandie
Caen
Hopital Louis Mourier
Colombes
Israel3 sites
Carmel Medical Center
Haifa
Rambam Hospital
Haifa
Tel-Aviv Sourasky Medical Center
Tel Aviv
United Kingdom2 sites
Nottingham University Hospitals NHS Trust
Nottingham
Nottingham University Hospitals, Neonatology: City Campus
Nottingham
About this 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
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.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- IBP-9414, Placebo
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBP-9414Drug
Oral suspension
PlaceboDrug
Sterile water
| Study group | Role | What they receive |
|---|---|---|
| IBP-9414 | Active comparator | Not described Receives: Drug: IBP-9414 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed necrotizing enterocolitis (NEC)
Measured: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Time to sustained feeding tolerance
Measured: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary outcomes (7)
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.
Measured: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Surgery (or autopsy) with confirmation of NEC
Measured: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Death all causes
Measured: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Number of days of hospitalization
Measured: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Weight gain in g/kg
Measured: Weeks 3 and 4 of age
Number of subjects growing at ≥100 g/kg/week
Measured: Weeks 3 and 4 of age
Days with clinical signs of feeding intolerance
Measured: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start4 Jul 2019
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infant Bacterial Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josef Neu, MD, Principal investigator, University of Florida College of Medicine, Gainsville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978000
- Sponsor's protocol ID
- IBP-9414-020
- Status last verified
- Apr 2024
- First submitted
- 5 Jun 2019
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Frazer LC, Orgel KA, Good M. Dysbiotic Microbiota in Necrotizing Enterocolitis: Insights into Pathogenesis, Treatment, and Prevention. Gastroenterol Clin North Am. 2025 Jun;54(2):415-427. doi: 10.1016/j.gtc.2024.11.001. Epub 2025 Jan 24.
PubMed 40348496Calvo LN, Greenberg RG, Gray KD. Safety and Effectiveness of Probiotics in Preterm Infants with Necrotizing Enterocolitis. Neoreviews. 2024 Apr 1;25(4):e193-e206. doi: 10.1542/neo.25-4-e193.
PubMed 38556499
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03978000
- Acronym / sponsor ID
- IBP-9414-020
- Conditions
- Necrotizing Enterocolitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,158 participants (actual)
- Lead sponsor
- Infant Bacterial TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBP-9414 | Active comparator | Drug: IBP-9414 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBP-9414Oral suspension | Drug | IBP-9414 |
| PlaceboSterile water | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Derived from this study: PubMed 40348496Frazer LC, Orgel KA, Good M. Dysbiotic Microbiota in Necrotizing Enterocolitis: Insights into Pathogenesis, Treatment, and Prevention. Gastroenterol Clin North Am. 2025 Jun;54(2):415-427. doi: 10.1016/j.gtc.2024.11.001. Epub 2025 Jan 24.
- Derived from this study: PubMed 38556499Calvo LN, Greenberg RG, Gray KD. Safety and Effectiveness of Probiotics in Preterm Infants with Necrotizing Enterocolitis. Neoreviews. 2024 Apr 1;25(4):e193-e206. doi: 10.1542/neo.25-4-e193.
Related trials for Necrotizing Enterocolitis
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Neu, MD principal investigator
University of Florida College of Medicine, Gainsville, FL
89 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBP-9414 in people with Necrotizing Enterocolitis, run by Infant Bacterial Therapeutics at 89 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Hungary, Bulgaria, Romania, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed necrotizing enterocolitis (NEC) (time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03978000, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.