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Arginine supplement may boost immunity in newborns after bowel surgery

NCT ID NCT05306925

Knowledge-focused Sponsor: University of Liverpool Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether giving extra arginine (a nutrient) to preterm and full-term infants after major bowel surgery or a serious gut infection (necrotising enterocolitis) can improve their immune function. Researchers will measure changes in gene activity related to infection-fighting cells. 48 infants will be split into groups receiving arginine in different ways or standard nutrition. The goal is to understand if arginine can help these vulnerable babies recover better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Arginine (dietary supplement)
What this could lead to
If it works, this could point toward a simple nutritional supplement to help babies fight infections after surgery.
What could go wrong
This is a very early exploratory study with only 48 infants, so results may not be conclusive or lead to a treatment. It focuses on gene activity, not direct health outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 44 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Preterm infants born \<30 weeks gestation requiring laparotomy/major bowel surgery or diagnosed with necrotising enterocolitis (Modified Bell's Stage II or higher) before discharge * Term and near term infants (born\>35 weeks gestation) requiring laparotomy/major bowel surgery in the first 3 days of life (gastroschisis; major bowel atresias expected to require at least 7 days of PN) Exclusion Criteria: * Infants who are unlikely to survive because of poor immediate postoperative condition * Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction * Parents who are unable to give informed consent

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Conditions

The condition(s) this trial relates to.

gastroschisis immune system disorder Malnutrition necrotizing enterocolitis nutritional deficiency disease Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune system and related disorders Nutritional deficiency Preterm Surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alder Hey Children's Hospital

    RECRUITING

    Liverpool, Merseyside, L14 5AB, United Kingdom

  • Liverpool Women's Hospital

    RECRUITING

    Liverpool, Merseyside, L8 7SS, United Kingdom

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