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New injection aims to fix choline deficiency in intestinal failure patients

NCT ID NCT06910943

Disease control Sponsor: Protara Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study tests an injectable form of choline, a nutrient often missing in people with intestinal failure who rely on IV nutrition. The goal is to see if it can safely raise choline levels and reduce liver injury. About 129 adolescents and adults will receive either a low or high dose of choline or a placebo over several weeks, with long-term follow-up.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 129 people

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

Started

Dec 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 years and older

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.

Key Inclusion Criteria: * Male or female 12 years of age or older at the time of signing the informed consent * Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry * Individuals with intestinal failure receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated who are receiving stable PS at time of screening and for the duration of the study; Note: Long-Term PS = Participant must have been receiving PS for at least 6 months prior to screening and requiring PS at least 3 times per week * Females of childbearing potential must have a negative urine pregnancy test at screening Key Exclusion Criteria: * Participants taking steatogenic medications or any medicine that could affect the measurement of hepatic steatosis within 12 weeks prior to signing consent * Evidence of systemic active infection at the time of dosing * Participants intending to take non-study drug choline supplements or choline-containing multivitamins during the course of the study * Participants unwilling to limit alcohol intake to no more than 20/g a day for 24 hours prior to their screening visit and for the duration of the study * Active malignancy (excluding basal cell skin tumor, low or very low risk prostate cancer, cervical carcinoma in situ and local resected cervical cancer) * Clinically significant renal disease * Low B12 or low serum folic acid levels that are less than the normal range * Participants with severe hepatic impairment, defined as Child-Turcotte-Pugh (CTP) Class C (score ≥10) at screening.

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Conditions

The condition(s) this trial relates to.

choline deficiency disease chronic intestinal failure drug-induced liver injury Hyperphagia Intestinal Failure

As listed by the trial registrant

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

Choline deficiency Liver injury

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites in 6 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aalborg University Hospital, Department of Medical Gastroenterology

    RECRUITING

    Aalborg, 9100, Denmark

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Beaujon Hospital - APHP

    RECRUITING

    Clichy, 92110, France

  • CHRU Nancy - Barbois Hospital

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • Charite - University Hospital Berlin

    RECRUITING

    Berlin, 13353, Germany

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/ New York Presbyterian Hospital

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Czerniakowski Hospital Sp. z o.o. (LCC)

    RECRUITING

    Warsaw, 00-739, Poland

  • Duke Clinic - Abdominal Transplant Research Office

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Floridian Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • M. Pirogow Provincial Specialized Hospital in Lodz, Nutritional Treatment Center

    RECRUITING

    Lodz, 90-532, Poland

  • Nebraska Medicine

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68105, United States

  • Pinnacle Clinical Research- San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Rennes University Hospital Center - Pontchaillou Site

    WITHDRAWN

    Rennes, 35000, France

  • Rigshospitalet - University Hospital Copenhagen

    RECRUITING

    Copenhagen, 2100, Denmark

  • University Duisburg-Essen, University Hospital Essen

    RECRUITING

    Essen, 45147, Germany

  • University Hospitals Leuven, Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • University of Colorado School of Medicine

    RECRUITING

    Aurora, Colorado, 80045, United States

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