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Daily injection could free kids from IV nutrition dependency

NCT ID NCT03562130

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 2 times

Summary

This study tested a daily injection called teduglutide (Revestive) in 25 children aged 2 to 18 with short bowel syndrome who rely on IV nutrition. The goal was to see if the drug helps their intestines absorb more nutrients, so they can reduce or stop IV feedings. Researchers measured changes in IV nutrition needs, stool output, and quality of life over the long term.

What this could mean

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

Active substance
Teduglutide (Revestive), a daily injection that helps the intestines absorb more nutrients
What this could lead to
If it works, this could help children with short bowel syndrome reduce or stop needing IV nutrition, improving their daily life and reducing complications.
What could go wrong
This is a small, single-center study with only 25 children, so results may not apply to everyone. The treatment requires daily injections and may not work for all patients.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

25 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 2020

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

2 to 18 years

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: * Being aged from 2 to 18 years old included ; * Presenting less than 80 cm of residual small intestine with or without the terminal ileum, ileocecal valve and right colon or having less than 120 cm in case of Short Bowel Syndrome (SBS) caused by Hirschsprung disease; * Being stable on PN support (inability to significantly reduce PN intake for the last six months before inclusion) ; * Being dependent on PN for at least 2 years and enterally fed (oral or tube feeding) ; * Having a normal colonoscopy in the 12 months before screening for children with maintained colon (=SBS type 2 or 3) older than 12 years ; * Having signed the Informed consent form (or parents or legal representative for minor patients). Exclusion Criteria: * Having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ; * Having a clinically significant untreated intestinal obstruction or active stenosis ; * Having an unstable absorption due to cystic fibrosis or known DNA abnormalities ; * Presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ; * Having an unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of patients who had undergone ventricular or atrial septal defect repair ; * Having a history of cancer or clinically significant lymphoproliferative disease; excepted resected cutaneous basal or squamous cell carcinoma, or in situ non-aggressive and surgically resected cancer ; * Having participated in a clinical study using an experimental drug within 1 month or an experimental antibody treatment within 3 months prior to screening, or concurrent participation in any clinical study using an experimental drug that would affect the safety of teduglutide ; * Having already used native GLP-2 and glucagon-like peptide-1 analog or human growth hormone within 3 months prior to screening ; * Having already used oral or IV glutamine, octreotide, or dipeptidyl peptidase IV (DPP-IV) inhibitors within 3 months prior to screening ; * Having an active Crohn's disease which has been treated with biological therapy within the 6 months prior to screening ; * Having an intestinal polyposis; * Being, for female patient, both lactating and breast-feeding or having a positive pregnancy test during the screening period; * Refusing the follow the protocol requirements in terms of birth control ; * Being unable to follow the study procedures for any reason: psychological, geographical… * Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Summary of Product Characteristics (SPC), or trace residues of tetracycline. * Active or suspected malignancy. * Patients with a history of malignancies in the gastrointestinal tract including the hepatobiliary system within the last five years.

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Conditions

The condition(s) this trial relates to.

Hyperphagia Intestinal Failure short bowel syndrome

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hôpital Necker - Enfants malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.