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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Aalborg University Hospital	Aalborg	Denmark
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Rigshospitalet	Copenhagen	Denmark
Vrije Universiteit Brussel	Jette	Belgium
Hopital Beaujon	Clichy	France
Ufcsoymoxptosjvpdnxqn Eshbx Afx	Essen	Germany
Wxyoudubkg Swcnirkxjsoeslt Skdvevo Ish Mx Pdtrifuj W Lxnwr	Lodz	Poland
Nngbbgbsgiaq Zwwsbr Ojorbe Zjnsoudcqr Sinmtcujnu Shl z osym	Bydgoszcz	Poland
Semtaho Cdydgqzzoasnr Sez z owac	Warsaw	Poland
Cees Ds Ngokt	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	03.09.2025
Denmark	Recruiting	03.09.2025
France	Recruiting	03.09.2025
Germany	Recruiting	03.09.2025
Poland	Recruiting	03.09.2025

Trial locations

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.

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 ID:

2024-519496-26-00

Protocol code:

TARA-001-301

NCT ID:

NCT06910943

Trial Phase:

Therapeutic use (Phase IV)

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

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