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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hopital Necker Enfants Malades	Paris	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Isala Klinieken Stichting	Zwolle	The Netherlands
San Camillo Forlanini Hospital	Rome	Italy
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Azienda Ospedaliera di Padova	Padua	Italy
Policlinico Casilino	Rome	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Norrlands University Hospital	Umea	Sweden
Universita’ Politecnica Delle Marche	Ancona	Italy
Centre Hospitalier Universitaire De Rennes	Rennes	France
Servei De Salut De Les Illes Balears	Palma	Spain
Centre Hospitalier Intercommunal De Poissy Saint Germain	St Germain En Laye	France
Uatmbgvtznhj Mmbqfci Ciinrhf Gzjxqlbjk	Groningen	The Netherlands
Uuvjkxyrmxhdsusdkcx Sfppu	Lund	Sweden
Sqxlg Unhhfbjtbb Hfggyffm	Malmo	Sweden
Aatczovfd Uxd	Amsterdam	The Netherlands
Uxhwmqo Utgqfpgqoc Hjobnkxb	Uppsala	Sweden
Fusygvsmu Pnka Lm Izkzbljrxftlj Bprfthdqt Drm Hfqgviou Uqcjervplhbey La Pdb	Madrid	Spain
Lladzvnbejevynblc Sfzlzgde	Salzburg	Austria

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	03.03.2025
France	Recruiting	03.03.2025
Italy	Recruiting	03.03.2025
Spain	Recruiting	03.03.2025
Sweden	Recruiting	03.03.2025
The Netherlands	Recruiting	03.03.2025

Trial locations

Investigated drugs:

Insulin Human

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.

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.

Trial ID:

2024-517101-87-00

Protocol code:

FIT-PIV

NCT ID:

NCT05670951

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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