Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

July 31, 2025 updated by: Elgan Pharma Ltd.

A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • AZ Sint-Jan
      • Brussel, Belgium
        • UZ Brussel
      • Liege, Belgium
        • CHR de la Citadelle
      • Rocourt, Belgium
        • CHC Cliniques Saint-Vincent
      • Wilrijk, Belgium
        • GZA Sint-Augustinus
  • France
      • Nancy, France
        • CHRU Nancy, Maternité Régionale
      • Paris, France
        • CHU Necker-Enfants Malades
      • Rennes, France
        • CHU - Hôpital Sud
  • Germany
      • Berlin, Germany
        • Kinderklinik, Evangelisches Waldkrankenhaus Spandau
      • Dresden, Germany
        • Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden
      • Nürnberg, Germany
        • Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat
      • Pforzheim, Germany
        • Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim
      • Spandau, Germany
        • Kinderklinik, Evangelisches Waldkrankenhaus
  • Hungary
      • Debrecen, Hungary
        • DE KK Gyermekklinika
      • Szeged, Hungary
        • Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly
      • Székesfehérvár, Hungary
        • Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi
      • Veszprém, Hungary
        • Csolnoky Ferenc Korhaz
  • Israel
      • Ashqelon, Israel
        • Barzilai MC
      • Be'er Sheva, Israel
        • Soroka Medical Center
      • Haifa, Israel
        • Rambam Health Care Campus
      • Haifa, Israel
        • Bnai zion MC
      • Netanya, Israel
        • Laniado
      • Petach Tikva, Israel
        • Schneider Children's Medical Center
      • Ramat Gan, Israel
        • Sheba MC
      • Tel Aviv, Israel
        • Tel Aviv Sourasky MC
  • Italy
      • Ancona, Italy
        • Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona
      • Milan, Italy
        • Granda Ospedale Maggiore Policlinico
      • Milan, Italy
        • Ospedale dei Bambini "V.Buzzi"- Azienda ICP
      • Monza, Italy
        • Azienda Ospedaliera San Gerardo
      • Rome, Italy
        • Policlinico Gemelli
      • Udine, Italy
        • Azienda Ospedaliero Universitaria
      • Varese, Italy
        • Ospedale F. Del Ponte - Azienda Ospedaliera di Varese
  • Netherlands
      • Amsterdam, Netherlands
        • AMC - Academic Medical Center
      • Groningen, Netherlands
        • UMC Groningen (UMCG), Beatrix Kinderziekenhuis
      • Zwolle, Netherlands
        • Isala Klinieken
  • Spain
      • Barcelona, Spain
        • Vall d'Hebron
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • La-Paz
      • Murcia, Spain
        • Hospital Universitario Virgen de la Arrixaca
      • Santiago, Spain
        • CHUS - Complejo Hospitalario Universitario de Santiago
      • Valencia, Spain
        • Hospital Universitario La Fe
  • United Kingdom
      • Bradford, United Kingdom
        • Bradford Royal Infirmary
      • Leicester, United Kingdom
        • University Hospital of Leicester NHS Trust- Royal Infirmary
      • Nottingham, United Kingdom
        • Queen's Medical College
      • Nottingham, United Kingdom
        • Queens Medical Center
      • Portsmouth, United Kingdom
        • Portsmouth Hospitals NHS Trust
  • United States
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Vidant Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 5 days (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
  2. Birth weight ≥ 500g
  3. Singleton or twin birth

Exclusion Criteria

1. Complete enteral feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NTRA-2112 A
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: NTRA-2112
Experimental: NTRA-2112 B
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: NTRA-2112
Placebo Comparator: Placebo
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numbers of Days to Achieve Complete Enteral Feeding
Time Frame: 28 days or discharge from hospital

Numbers of days to achieve full enteral feeding (NFE) is defined as:

Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.
28 days or discharge from hospital

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
Time Frame: 28 days or discharge from hospital

Readiness for discharge from hospital is defined as achieving all of the below:

  • Infant weight ≥ 1800g
  • Stable body temperature
  • Capable of oral feeding (reached full enteral feeding and not dependent on PN)
28 days or discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elgan Pharma Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FIT-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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