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Study on the Safety of ELGN-2112 for Preterm Infants with Intestinal Malabsorption

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety of a treatment called ELGN-2112 in infants with a condition known as Intestinal Malabsorption. Intestinal Malabsorption is a condition where the intestines cannot absorb nutrients properly. The treatment being tested is an oral solution containing Insulin Human, which is a protein that helps regulate blood sugar levels. The study will compare the effects of ELGN-2112 to a placebo in preterm infants born before 26 weeks of gestation and infants with Intra-Uterine Growth Restriction (IUGR), which means they are smaller than expected for their gestational age.

The purpose of the study is to assess the safety of ELGN-2112 in these specific groups of infants. Participants in the study will receive either the treatment or a placebo, and their health will be monitored over a period of time. The study will look at various factors, such as how long it takes for the infants to achieve full feeding through the intestines, the occurrence of a serious intestinal condition called Necrotizing Enterocolitis (NEC), and the number of days until they can be discharged from the hospital. The study will also track other health outcomes, including the incidence of infections and the infants' growth and development.

This trial is designed to provide important information about the safety of ELGN-2112 in helping infants with Intestinal Malabsorption and related conditions. By participating in this study, researchers hope to better understand how this treatment can support the health and development of these vulnerable infants.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves preterm infants born less than 26 weeks or infants with growth restrictions born between 26 and 32 weeks. The infant must be stable and able to tolerate feeding through a tube.
The infant's birth weight must be at least 450 grams, and they must be within five days of birth. The infant should not require blood pressure support through a central line.
Parents or legal guardians must sign an informed consent form for the infant to participate.
Step 2
Treatment administration
The treatment involves the administration of a powder reconstituted into an oral solution for feeding through a tube. This is compared to a placebo to assess safety.
The primary goal is to evaluate the safety of the treatment in preterm infants and those with growth restrictions.
Step 3
Monitoring and assessment
The study will monitor the number of days it takes for the infant to achieve full feeding through the tube, defined as at least 150 ml/kg/day for three consecutive days.
The study will also track the number of days until the infant can stop receiving nutrition through an IV, as well as the incidence and severity of any intestinal issues or infections.
Other assessments include the number of days until discharge from the hospital and the infant's growth and development.
Step 4
Completion of the study
The study is expected to continue until 2033, with recruitment starting in 2025.
The primary focus is on the safety of the treatment compared to a placebo, with various health outcomes being measured throughout the study period.

Who can join the trial?

11 criteria

The infant must be a preterm baby born before 26 weeks of pregnancy or an infant with Intra-Uterine Growth Restriction (IUGR), which means the baby is smaller than expected for the number of weeks of pregnancy, born between 26 and 32 weeks.
The infant must be stable enough, in the doctor's opinion, to complete the trial.
For participants in France, they must have a health insurance plan.
The infant's birth weight must be at least 450 grams.
The infant can be from a single birth or a twin birth.
The infant's age must be up to 5 days old (up to 120 hours after birth).
The infant must need a fraction of inspired oxygen of 0.60 or less at the time of joining the study. This means the amount of oxygen they need to breathe should not be too high.
The infant must have stable heart and blood pressure conditions at the time of joining the study. They should not need blood pressure support through a central line, which is a special tube used to give medicines or fluids.
The infant must be able to tolerate enteral feeds, which means they can be fed through a tube that goes into their stomach.
The infant is expected to stop needing parenteral nutrition (PN), which is nutrition given through a vein, at the main hospital where they are being treated.
The parents or legal guardian must sign an informed consent form, which is a document that explains the study and confirms their agreement for the infant to participate.

Who cannot join the trial?

1 criterion

Patients with **Intestinal Malabsorption** cannot participate. This means their intestines have trouble absorbing nutrients from food.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
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Madrid, Spain
Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

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Investigated drugs

ELGN-2112 is a medication being studied for its safety in specific groups of infants. The trial aims to understand how safe this medication is when given to preterm infants born before 26 weeks of gestation and infants with intrauterine growth restriction (IUGR) born between 26 and 32 weeks of gestation. The study is designed to compare the effects of ELGN-2112 with those of a placebo, focusing on these vulnerable populations.

Insulin Human

What is already known about the treatment

ELGN-2112 – This medication is administered orally and is currently being studied in clinical trials to evaluate its safety in specific infant populations. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for ELGN-2112 is to address intestinal malabsorption, particularly in preterm infants and those with intrauterine growth restriction. At the molecular level, its mechanism of action involves enhancing nutrient absorption in the intestines. ELGN-2112 is classified pharmacologically as a gastrointestinal agent.

Investigated diseases

Intestinal Malabsorption – This condition occurs when the small intestine cannot absorb nutrients effectively from food. It can lead to deficiencies in vitamins, minerals, and other essential nutrients, causing symptoms like diarrhea, weight loss, and fatigue. The condition may result from various underlying causes, including damage to the intestinal lining, infections, or certain medical conditions. Over time, if untreated, it can lead to more severe nutritional deficiencies and related health issues. The severity and progression of symptoms can vary depending on the underlying cause and the extent of malabsorption.