Choline Chloride for Intestinal Failure
(THRIVE-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the safety and effectiveness of Choline Chloride for Injection in individuals with intestinal failure who rely on long-term parenteral support (PS). PS is a method of feeding through the veins when regular eating isn't sufficient or possible. The trial will compare different doses of the treatment with a placebo (a substance with no active ingredient) to determine the best and safest dose. It seeks participants who have been on PS for at least six months and require it at least three times a week due to insufficient nutrition from eating. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take choline supplements or choline-containing multivitamins during the study. If you are on medications that affect liver fat measurement, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that choline chloride, the treatment tested in this trial, has been used safely in other contexts. Some studies have found it to be generally well-tolerated, with no serious side effects reported in humans at doses of 3000 mg per day or more.
This trial is in Phase 2/3, aiming to gather more detailed information on the treatment's safety and effectiveness. Earlier phases usually indicate that a treatment is safe enough for further testing, though not all side effects may be known yet.
In summary, existing research suggests that choline chloride is generally safe, but this trial will help confirm its safety for people with intestinal failure.12345Why are researchers excited about this trial's treatment for intestinal failure?
Unlike standard treatments for intestinal failure, which often involve parenteral nutrition and dietary modifications, Choline Chloride for Injection offers a novel approach. Researchers are excited about it because choline is a crucial nutrient that supports liver function and cell membranes, potentially addressing the root cause of nutrient absorption issues in intestinal failure. This treatment is delivered via injection, providing a direct and possibly more efficient way of replenishing choline levels, which could improve patient outcomes and quality of life more effectively than existing methods.
What evidence suggests that Choline Chloride for Injection might be an effective treatment for intestinal failure?
Research has shown that Choline Chloride for Injection might help people with intestinal failure. One study found that 78% of patients receiving nutrition intravenously had low choline levels. Among those with low choline, 63% experienced liver problems. Choline plays a crucial role in liver health, and supplementation might enhance liver function and overall health in these patients. Early results suggest promise for addressing liver issues related to intestinal failure. This trial will explore various doses of Choline Chloride to determine its effectiveness as a treatment for individuals relying on intravenous nutrition.16789
Who Is on the Research Team?
Chief Scientific Operations Officer
Principal Investigator
Protara Therapeutics
Are You a Good Fit for This Trial?
This trial is for adolescents and adults aged 12 or older with intestinal failure who rely on long-term parenteral support because they can't eat normally. Participants must have been on stable support for at least 6 months, receiving it a minimum of three times weekly, and females able to have children need a negative pregnancy test.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-Label Dose-Selection
Evaluate the safety, tolerability, and distribution of Choline Chloride for Injection to select 2 of 3 doses for further testing
Double-Blind, Placebo-Controlled
Assess the safety and efficacy of the study drug at the selected dose levels compared to placebo
Open-Label Extension
Participants may opt into continuation of treatment long-term to further assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Choline Chloride for Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Protara Therapeutics
Lead Sponsor