Recruiting

Study on the Effects of ELGN-2112 (Human Insulin) for Treating Intestinal Malabsorption in Preterm Infants

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying intestinal malabsorption in preterm infants. Intestinal malabsorption is a condition where the intestines cannot absorb nutrients properly, which can be particularly challenging for infants born prematurely. The study will evaluate the effects of a treatment called ELGN-2112, which is an oral solution containing insulin human. Insulin human is a protein that is commonly used to help regulate blood sugar levels, but in this study, it is being tested for its potential benefits in improving nutrient absorption in the intestines of preterm infants.

The purpose of the study is to assess how effective and safe ELGN-2112 is compared to a placebo in helping preterm infants reach full enteral feeding. Enteral feeding refers to delivering nutrition directly to the stomach or intestines, which is crucial for the growth and development of preterm infants. The study will involve two groups of infants: one group will receive the ELGN-2112 treatment, and the other group will receive a placebo. The main goal is to see how quickly infants can achieve full enteral feeding, defined as consuming at least 150 ml/kg/day for three consecutive days.

Throughout the study, researchers will monitor various aspects of the infants' health, including the time it takes to wean off parenteral nutrition (nutrition given through a vein), the occurrence of a serious intestinal condition called necrotizing enterocolitis (NEC), and the overall time to discharge from the hospital. The study aims to provide valuable insights into whether ELGN-2112 can help improve the health outcomes of preterm infants with intestinal malabsorption.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, the infant's eligibility is confirmed based on specific criteria such as gestational age, birth weight, and stability. The infant must be able to tolerate enteral feeds and is expected to wean off parenteral nutrition at the primary hospital.
The parents or legal guardian must sign an informed consent form to allow the infant to participate in the trial.
Step 2
Randomization
The infant is randomly assigned to one of two groups: one receiving the treatment with ELGN-2112 and the other receiving a placebo. This process is double-blind, meaning neither the parents nor the medical staff know which group the infant is in.
Step 3
Treatment administration
The assigned treatment, either ELGN-2112 or placebo, is administered as a powder reconstituted into an oral solution through an enteral feeding tube.
The dosage and frequency of administration are determined by the study protocol and are monitored by the medical team.
Step 4
Monitoring and assessments
Throughout the trial, the infant's health and progress are closely monitored. This includes tracking the number of days to achieve full enteral feeding, defined as the ability to consume at least 150 ml/kg/day for three consecutive days.
Additional assessments include monitoring for any adverse events, such as infections or necrotizing enterocolitis, and evaluating the infant's growth and development.
Step 5
Completion and follow-up
The trial concludes once the primary and secondary endpoints are reached, such as the infant being weaned off parenteral nutrition and discharged from the primary hospital.
Follow-up assessments may be conducted to ensure the infant's continued health and to gather additional data for the study.

Who can join the trial?

9 criteria

The infant must be a preterm baby, born between 26 and 32 weeks of pregnancy. This means the baby was born earlier than the full term of 40 weeks.
The baby's birth weight must be at least 500 grams.
The baby can be either a single birth or a twin.
The baby must be no older than 5 days after birth (up to 120 hours).
The baby must be able to breathe with a fraction of inspired oxygen of 0.60 or less at the time of joining the study. This means the baby should not need too much extra oxygen to breathe.
The baby must have a stable heart and blood pressure. If the baby needs blood pressure support through a central line, they are considered unstable.
The baby must be able to tolerate enteral feeds, which means they can receive nutrition through a feeding tube into the stomach.
The baby is expected to stop needing parenteral nutrition (nutrition given through a vein) at the main hospital.
The parents or legal guardian must sign an informed consent form, agreeing to the baby's participation in the study.

Who cannot join the trial?

1 criterion

Patients with **Intestinal Malabsorption** cannot participate. This means if your body has trouble absorbing nutrients from food, you are not eligible.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

ELGN-2112 is a medication being tested to see if it can help preterm infants who have trouble absorbing nutrients from their intestines. The goal of the study is to find out if this medication can help these infants reach full feeding by mouth more quickly. This means the infants would be able to take in enough milk or formula to grow and develop without needing extra nutrition through a tube or IV. The study is comparing the effects of ELGN-2112 to see if it works better than not using any active medication at all.

Insulin Human

What is already known about the treatment

ELGN-2112 – ELGN-2112 is administered orally and is being studied for its potential to help preterm infants with intestinal malabsorption, a condition where the intestines cannot absorb nutrients properly. Currently, this medication is in the clinical trial phase, and its effectiveness and safety are being compared to a placebo. The main goal of using ELGN-2112 is to improve the time it takes for these infants to reach full enteral feeding, which means they can receive all their nutrition through their digestive system. The exact way ELGN-2112 works at the molecular level is still under investigation, but it is classified as a treatment for digestive system disorders.

Investigated diseases

Intestinal Malabsorption – Intestinal malabsorption is a condition where the small intestine cannot absorb nutrients effectively from food. This can lead to deficiencies in vitamins, minerals, and other essential nutrients. The condition may result from damage to the intestinal lining, certain diseases, or infections. Symptoms often include diarrhea, weight loss, and fatigue due to the lack of nutrient absorption. Over time, it can cause growth and developmental issues, especially in infants and children. The progression of the condition depends on the underlying cause and the extent of the intestinal damage.