Study of Oral Vancomycin for Adults and Young Adults with Primary Sclerosing Cholangitis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called vancomycin on a liver disease known as Primary Sclerosing Cholangitis (PSC). PSC is a condition that causes inflammation and scarring of the bile ducts, which can lead to liver damage. Some patients with PSC also have another condition called Inflammatory Bowel Disease (IBD), which affects the digestive tract. The study will compare the effects of oral vancomycin with a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to see how vancomycin affects a specific liver enzyme called alkaline phosphatase (ALP) over a period of six months. Participants in the study will be randomly assigned to receive either vancomycin or the placebo. The study will include regular check-ups and tests to monitor the participants’ health and the effects of the treatment. These tests will include blood tests to measure liver enzymes and other markers, as well as assessments of the participants’ overall health and any side effects they may experience.

The study will also look at other factors, such as changes in liver function, the progression of liver disease, and the impact on IBD symptoms for those who have it. The goal is to gather information on the safety and effectiveness of vancomycin for treating PSC, with or without IBD, and to see if it can help improve liver health and quality of life for patients with these conditions.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility. This includes a review of your medical history and a physical examination.

You will be required to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks involved.

2 baseline assessments

Baseline assessments will be conducted to gather information about your current health status. This includes blood tests to measure levels of certain enzymes and other substances in your body.

A colonoscopy may be required if you do not have a documented history of inflammatory bowel disease (IBD).

3 randomization and treatment

You will be randomly assigned to receive either the study medication, oral vancomycin, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

The dosage and frequency of the medication will be determined by the study protocol. You will take the medication as instructed for a period of 6 months.

4 regular follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are scheduled to monitor your health and the effects of the treatment.

During these visits, various tests will be conducted, including blood tests, to check for any changes in your health status.

5 end of treatment assessments

At the end of the 6-month treatment period, you will undergo a series of assessments similar to the baseline assessments. This is to evaluate the effects of the treatment on your condition.

These assessments will include blood tests and possibly imaging tests to check the condition of your liver and bile ducts.

6 follow-up period

After completing the treatment, there will be a follow-up period to monitor your health. This is to ensure that any changes in your condition are observed and managed appropriately.

You may be required to attend additional visits during this period for further assessments.

Who Can Join the Study?

Willing and able to give informed consent before any study-specific procedure is done.
Must be a male or a non-pregnant, non-breastfeeding female, including women who can have children, aged between 15-70 years at the time of giving consent.
Must have a diagnosis of large-duct Primary Sclerosing Cholangitis (PSC) based on a special imaging test called a cholangiogram, which can be done using methods like MRCP, ERCP, or PTC, following the latest guidelines.
Must have a baseline level of a liver enzyme called alkaline phosphatase (ALP) that is at least 1.5 times the upper limit of normal at screening.
Must not have any bile duct blockage or cancer within 6-12 months before joining the study.
If taking medications like ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid, the patient should continue the same daily dose during the study.
If the patient has taken antibiotics or probiotics, they can join if they stopped taking them at least 3 months before the study starts.
If the patient has been on obeticholic acid or other experimental treatments for PSC, they must stop these treatments at least 3 months before joining the study.
Can have PSC with or without Inflammatory Bowel Disease (IBD). If they have IBD, it should be documented and have lasted at least 6 months, with the disease being in remission or only mildly active. If they do not have documented IBD, they need a colonoscopy with segmental biopsies within 12 months before the study starts.
Female participants who can have children must test negative for pregnancy at screening, baseline, and follow-up visits. If they engage in sexual intercourse, they must agree to use specific methods of birth control.

Who Cannot Join the Study?

Patients with any other liver disease besides Primary Sclerosing Cholangitis cannot participate.
Patients who have had a liver transplant are not eligible.
Patients with severe heart problems cannot join the study.
Patients with uncontrolled diabetes are excluded.
Patients who are pregnant or breastfeeding cannot take part.
Patients who are currently participating in another clinical trial are not allowed to join.
Patients with a history of alcohol or drug abuse in the past year are excluded.
Patients with any condition that the study doctors think would make it unsafe for them to participate cannot join.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	15.06.2023

Trial locations

Investigated drugs:

Vancomycin

Oral Vancomycin is an antibiotic that is being tested in this clinical trial. It is usually used to treat certain types of bacterial infections in the intestines. In this study, researchers are exploring its potential benefits for people with a liver condition called Primary Sclerosing Cholangitis, which can occur with or without another condition known as Inflammatory Bowel Disease. The goal is to see if oral vancomycin can help improve liver function by lowering a specific enzyme level in the blood, called alkaline phosphatase, over a period of six months.

Primary Sclerosing Cholangitis – Primary Sclerosing Cholangitis is a chronic liver disease characterized by inflammation and scarring of the bile ducts. Over time, the scarring can cause the bile ducts to become narrowed or blocked, leading to liver damage. The disease progresses slowly, often over many years, and can result in liver cirrhosis. Symptoms may include fatigue, itching, and jaundice, although some individuals may remain asymptomatic for a long period. The exact cause of the disease is unknown, but it is often associated with inflammatory bowel diseases like ulcerative colitis. As the disease advances, complications such as bile duct infections and deficiencies in fat-soluble vitamins may occur.

Trial ID:

2023-507425-42-00

Protocol code:

VanC-IT

NCT ID:

NCT05876182

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Oral Vancomycin for Adults and Young Adults with Primary Sclerosing Cholangitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?