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Can an amino acid pill help the body build protein when the gut fails?

NCT ID NCT01386034

Symptom relief Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether taking citrulline by mouth helps people with intestinal failure build protein more effectively. The study includes adults with short bowel syndrome who are fed orally and not on parenteral nutrition. Participants receive either citrulline or a placebo for seven days, then undergo a five-hour infusion of a safe, labeled amino acid to measure how their bodies handle protein. The goal is to see if citrulline boosts whole-body protein synthesis and improves nitrogen balance.

What this could mean

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

Active substance
citrulline, an amino acid supplement
What this could lead to
If citrulline helps the body build protein, it could offer a simple oral supplement to support nutrition in people whose intestines cannot absorb enough nutrients.
What could go wrong
The trial is very small, with only 11 participants, so results may not apply broadly. Citrulline might not change protein synthesis enough to matter, and the isotope infusion method is complex and could yield unclear data.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

11 people

The number who actually took part.

Start date

Jul 2012

Finished

Jul 2015

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

18 to 75 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: * Adult between 18 and 75 years * Patient with short bowel syndrome * Patient with an incompetent small intestine after intestinal resection * Patient fed orally and beyond more than 6 weeks after surgery * Absence of any earlier supplementation with citrulline, glutamine, ornithine a-ketoglutarate, or stimol® * No current artificial feeding (parenteral) * No low-sodium diet- No renal, cardiac, respiratory or hepatic insufficiency * No chronic inflammatory disease (intestinal or other) * No current corticosteroid treatment * Fasting blood glucose below 6mmol/L * Patient able to understand benefits and risks of protocol * Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 15 days following the end of the study * Signed informed consent Exclusion Criteria: * Subject not fulfilling inclusion criteria * Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique" * Pregnancy

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Conditions

The condition(s) this trial relates to.

chronic intestinal failure Intestinal Failure short bowel syndrome

As listed by the trial registrant

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

Intestinal failure

Contacts and locations

Locations

  • Clinique Saint Yves

    Rennes, France

  • Nantes University Hospital

    Nantes, France

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