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Evaluation of Choline Chloride for Intestinal Failure Patients Receiving Long-Term Parenteral Support

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying intestinal failure, a condition where the intestine cannot absorb enough nutrients to maintain health, requiring patients to receive long-term parenteral support (nutrition delivered directly into the bloodstream, bypassing the digestive system). The study will evaluate Choline Chloride for Injection at different doses compared to placebo. Choline is an essential nutrient that the body needs for many functions, including liver health and cell membrane integrity. The purpose of this study is to determine if Choline Chloride for Injection can serve as an effective source of choline for adolescents and adults with intestinal failure who are receiving long-term parenteral support.

The study consists of several phases: a dose-selection phase to determine appropriate dosing, a double-blind phase where participants receive either Choline Chloride for Injection or placebo, and an open-label extension where all participants receive the active treatment. Throughout the study, researchers will monitor plasma free choline concentrations (the amount of choline in the bloodstream), liver function tests, and other health indicators. The study will also use MRI-PDFF (magnetic resonance imaging-proton density fat fraction) to measure liver fat content and MRE (magnetic resonance elastography) to assess liver stiffness, which indicates fibrosis or scarring.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting the clinical trial

    After joining the study, you will be assigned to receive either Choline Chloride for Injection (at either a low dose or high dose) or a placebo (a substance that looks like the medication but contains no active ingredient).

    The study has three main phases: a Dose-Selection phase, a Double-Blind phase, and an Open-Label Extension phase. The total duration of the trial is approximately 64 weeks.

  2. Step 2

    Initial assessments

    At the beginning of the study, you will undergo baseline assessments including blood tests to measure your plasma free choline levels and liver function tests.

    Other measurements will include height, weight, and body mass index (BMI).

    You will complete quality of life questionnaires and undergo imaging tests such as MRI-PDFF (a type of magnetic resonance imaging that measures fat in the liver) and MRE (magnetic resonance elastography, which measures liver stiffness).

  3. Step 3

    Dose-Selection Phase

    During the first 8 weeks, you will receive Choline Chloride for Injection at either a low or high dose.

    Blood samples will be collected during Week 1 and Week 8 to measure how the medication is processed in your body (pharmacokinetics or PK).

    You will also have an electrocardiogram (ECG) to monitor your heart rhythm, with measurements taken three times (triplicate) during Week 1 and Week 8.

    The medication will be added to your regular parenteral support (nutrition delivered directly into your bloodstream because your intestines cannot absorb enough nutrients).

  4. Step 4

    Double-Blind Phase

    Following the Dose-Selection phase, you will enter the Double-Blind phase, which lasts from Week 8 to Week 24.

    During this phase, you will receive either Choline Chloride for Injection or placebo. Neither you nor the study staff will know which one you are receiving.

    Blood tests will continue to be performed to monitor choline levels and liver function.

    At Week 24, you will undergo follow-up imaging tests (MRI-PDFF and MRE) and complete quality of life questionnaires again.

  5. Step 5

    Open-Label Extension Phase

    After completing the Double-Blind phase, you will enter the Open-Label Extension phase, which continues until Week 64.

    During this phase, all participants will receive Choline Chloride for Injection (no placebo).

    Blood tests and other assessments will continue to be performed periodically.

    A final set of imaging tests and quality of life assessments will be completed at Week 64.

  6. Step 6

    Regular monitoring throughout the study

    Throughout all phases of the study, you will be monitored for any side effects or adverse events.

    Blood tests will regularly measure your choline levels, liver function tests (including ALP, AST, ALT, GGT), VLDL (a type of cholesterol), bilirubin levels, CPK (an enzyme that indicates muscle damage), homocysteine, and albumin levels.

    Your height, weight, and BMI will be measured periodically to track any changes.

    You will need to maintain a stable parenteral support regimen throughout the study, including consistent amounts of lipid emulsion, dextrose, amino acids, vitamin B12, and folic acid.

  7. Step 7

    Completion of the study

    The study will conclude after the Week 64 assessments are completed.

    Final evaluations will include blood tests, imaging studies, and quality of life questionnaires.

    The results will help determine if Choline Chloride for Injection is effective as a source of choline for people with intestinal failure who are receiving long-term parenteral support.

Who can join the trial?

6 criteria

  • You must be 12 years of age or older when signing the informed consent form.
  • You must voluntarily provide written informed consent after the study has been explained to you. If you're under 18 or unable to consent, your legally authorized representative or parents/guardians can provide consent.
  • You must have intestinal failure (a condition where your intestines cannot digest food or absorb nutrients properly) and be receiving long-term PS (parenteral support, which is nutrition given through a vein) because oral or tube feeding is not possible, not enough, or not recommended.
  • Your PS must be stable at the time of screening and throughout the study, meaning:
    • You must be receiving stable amounts of lipid emulsion (fats), dextrose (sugar), and amino acids (protein components) for at least 4 weeks before screening
    • You must be receiving vitamin B12 and folic acid supplements
    • If you're a female who can become pregnant, you must have a negative urine pregnancy test at screening.

Who cannot join the trial?

14 criteria

  • Expecting a baby or breastfeeding
  • Inability to absorb the medication due to digestive system issues
  • Taking certain medications called methacholine or bethanechol (medicines that affect muscles and nerves)
  • Having an abnormally slow heartbeat (less than 60 beats per minute)
  • Having a condition called asthma (a lung disease that makes breathing difficult)
  • Having a condition called peptic ulcer (sores in the lining of the stomach or small intestine)
  • Having a condition called hyperthyroidism (overactive thyroid gland)
  • Having seizures or epilepsy (a brain disorder causing seizures)
  • Having Parkinson's disease (a brain disorder affecting movement)
  • Having high blood pressure
  • Receiving or planning to receive certain nerve blockers called depolarizing neuromuscular blocking agents
  • Having participated in another clinical study in the past 30 days
  • Being allergic to any component of the study medication
  • Having any medical condition that the study doctor believes would make participation unsafe
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Investigated drugs

  • Choline Chloride for Injection

    is a medication being studied for individuals with intestinal failure who are receiving long-term parenteral support (nutrition delivered through a vein rather than through the digestive system). Choline is an essential nutrient that helps support various bodily functions including liver health, brain development, and nerve function. This treatment is being tested to see if it can effectively provide choline to patients who may have difficulty getting enough through their current nutritional support.

  • Placebo

    is an inactive substance that looks like the medication being tested but contains no active ingredient. In this study, some participants will receive the placebo instead of choline chloride to help researchers determine if the effects seen with choline chloride are actually due to the medication itself.

What is already known about the treatment

Choline Chloride for Injection – A parenteral (intravenous) form of choline supplementation designed for patients with intestinal failure who are receiving long-term parenteral support. This essential nutrient is currently being investigated in Phase 2b/3 clinical trials for its potential to address choline deficiency in patients who cannot adequately absorb nutrients through their digestive system. Choline Chloride works by providing the body with exogenous choline, a vital nutrient that supports cell membrane integrity, neurotransmitter synthesis, and lipid transport. Pharmacologically classified as a nutritional supplement, this treatment aims to prevent complications associated with choline deficiency in patients dependent on parenteral nutrition who may not receive adequate amounts of this essential nutrient through conventional formulations.

Investigated diseases

Intestinal Failure is a condition characterized by the inability of the gastrointestinal tract to absorb sufficient nutrients and fluids to maintain health and growth. It occurs when there is a significant reduction in the functional gut mass below the minimum amount necessary for adequate digestion and absorption. Intestinal failure can develop due to various underlying conditions, including short bowel syndrome, motility disorders, or extensive small bowel mucosal disease. The condition typically progresses with symptoms of malnutrition, dehydration, weight loss, and vitamin and mineral deficiencies. Patients with intestinal failure often experience reduced quality of life due to the chronic nature of their symptoms and may develop complications related to nutrient deficiencies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-519496-26-00Protocol codeTARA-001-301Estimated enrolment144 patientsSponsorProtara Therapeutics Inc.

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