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Study on the use of oral vancomycin for children with ulcerative colitis

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study focuses on Ulcerative Colitis, which is a type of Inflammatory Bowel Disease that causes swelling and irritation in the digestive tract. The research aims to determine the effectiveness of oral vancomycin in managing different forms of this condition in children. This medication is an antibiotic used to treat certain types of infections.

The study examines how patients respond to the treatment by looking at changes in their commensal microbiota, which refers to the helpful bacteria that naturally live inside the gut. Participants will undergo a process to compare their health status and the composition of their intestinal bacteria before starting the vancomycin treatment and after completing it to see if the medicine helps achieve remission, a state where the disease symptoms are gone and the gut is no longer inflamed.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Medication administration
The treatment involves taking vancomycin, which is an antibiotic (a medicine used to fight bacterial infections), in the form of oral capsules.
A daily total dose of 1500 mg is administered through the mouth.
Step 2
Clinical monitoring
The progress is monitored by checking for remission, which means the ulcerative colitis (a condition causing inflammation in the large intestine) symptoms are gone and the child is symptom-free.
A measurement of calprotectin, which is a protein found in the stool that indicates the level of inflammation in the intestines, is performed to ensure levels are below 100.
Step 3
Microbiota analysis
The composition and function of the commensal microbiota, which are the beneficial bacteria living in the gut, are examined.
This analysis is conducted before starting the vancomycin or standard treatment and again after the treatment has reached the remission stage.

Who can join the trial?

10 criteria

You must be between 6 and 16 years old.
You must have a confirmed diagnosis of atypical ulcerative colitis, which is a type of long-term inflammation in the large intestine that shows unusual patterns, such as affecting only certain parts of the colon or having specific markers in the blood.
You may have or not have PSC (primary sclerosing cholangitis), which is a condition that causes inflammation and scarring in the bile ducts in the liver, as seen on a special medical scan called an MRCP.
You or your guardian must agree to participate in OVT (oral microbiota transplantation), which is a treatment where beneficial bacteria are taken by mouth to help balance the bacteria in the gut, for at least 3 months.
You must not have received OVT in the past.
You must be able to swallow capsules.
You must not have an active infection, such as clostridium (a type of harmful bacteria) or other bacteria, based on a stool test before starting the treatment.
You must not have started any new medications or new standard treatments for IBD (inflammatory bowel disease) within the 4 weeks before starting the treatment.
You are allowed to use contraceptives (birth control) or other medications, as long as they are not antibiotics (medicines used to kill bacteria).
If you are a healthy participant, you must have no symptoms or suspicion of inflammatory bowel disease but are scheduled to have an endoscopy (a procedure where a doctor uses a small camera on a tube to look inside the body) for other reasons.

Who cannot join the trial?

9 criteria

People who have Primary Sclerosing Cholangitis (a condition where the bile ducts in the liver become inflamed and scarred) but do not have Ulcerative colitis (a disease that causes swelling and sores in the digestive tract).
People who have Crohn’s disease, which is another type of long-term swelling in the digestive system.
Children who are under 6 years old.
People who have difficulty swallowing capsules (the small pill-shaped containers used for medicine).
People who have had an allergic reaction to vancomycin (a specific type of antibiotic used to treat infections) or other medicines similar to it.
People who have malignant disease (cancer) or might need a liver transplant (a surgery to replace a diseased liver with a healthy one) in the next 12 months.
People who are pregnant.
For healthy participants: people with a chronic illness (a health condition that lasts for a long time) that requires taking medicine regularly.
For healthy participants: people who have used antibiotics (medicines used to kill bacteria) in the last 6 months.

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Pirkanmaan hyvinvointialue
Verified
Tampere, Finland

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Investigated drugs

Vancomycin is an antibiotic taken by mouth that is being tested to see how well it helps manage different types of inflammatory bowel disease in children. The study looks at how this medicine affects the bacteria living in the gut.

Vancomycin Hydrochloride

What is already known about the treatment

Vancomycin hydrochloride - This medication is taken by mouth in the form of hard capsules. It is a well-established antibiotic used to treat specific bacterial infections, particularly those occurring in the digestive tract. The drug works by preventing bacteria from building their protective cell walls, which causes the bacteria to die. It is classified as a glycopeptide antibiotic and is used in this study to help manage inflammatory bowel diseases like ulcerative colitis.

Investigated diseases

Ulcerative colitis - This is a type of long-term inflammation that affects the digestive tract. It specifically targets the lining of the large intestine and the rectum. The condition causes inflammation and small sores called ulcers to develop on the inner surface of these organs. Over time, the inflammation may move along the colon, causing various symptoms. It is characterized by periods where symptoms are active and periods where they are not.