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Study of guselkumab and dietary changes for patients with recurring or difficult-to-treat pouchitis

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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 Pouchitis, which is a condition involving inflammation of the pouch created in the digestive tract after certain surgeries. The research aims to evaluate the effectiveness of the drug guselkumab, given as a subcutaneous injection, either alone or when combined with specific changes in food intake. Participants may receive the medication through a pre-filled syringe containing a liquid solution.

During the study, individuals with recurring or difficult-to-treat symptoms will be monitored to see how they respond to the treatment. Some participants will receive guselkumab along with a dietary intervention, which means following specific eating guidelines, while others will only receive the medication. The course of the study involves regular check-ups over several weeks to observe changes in symptoms, the state of the intestinal lining, and levels of inflammation in the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment initiation
Administration of guselkumab begins. this is a subcutaneous injection, which means it is injected under the skin, using a pre-filled syringe.
The dose provided is 400 mg.
Step 2
Dietary intervention and monitoring
Depending on the assigned group, a dietary intervention may be required. if assigned to this group, food records and food frequency questionnaires must be completed to track eating habits.
Changes in intestinal microbiota, which are the bacteria living in the gut, are monitored at weeks 8, 16, 24, 32, 40, and 48.
Blood tests and stool tests are conducted at specific intervals, including weeks 8, 16, 24, 32, 40, and 48, to measure levels of c-reactive protein (crp), which is a marker of inflammation, and faecal calprotectin, which is a protein found in stool that indicates intestinal inflammation.
Step 3
Short-term evaluation
At week 16, the effectiveness of the guselkumab and any dietary intervention is assessed. clinical remission, which is the absence of symptoms, is evaluated using the mpdai score (a tool used to measure the severity of pouchitis, an inflammation of the intestinal pouch).
Evaluations at this stage include checking for a reduction in mpdai scores, endoscopic subscores (visual inspection of the intestinal lining), and histologic subscores (examination of tissue samples under a microscope).
Step 4
Long-term evaluation
The study continues until week 48 to assess long-term clinical remission and the effectiveness of the treatment.
Additional measurements of guselkumab levels in the blood and the presence of anti-guselkumab antibodies (proteins the body may create in response to the medication) are performed at weeks 8, 16, 24, 32, 40, and 48.

Who can join the trial?

10 criteria

You must provide voluntary written informed consent, which means you or your legal representative agrees to participate in the study by signing a document after being fully informed about it.
You must be able to read and speak Dutch fluently.
You must be at least 18 years old but younger than 80 years old at the time of signing the agreement.
You must use highly effective birth control, such as implants, certain pills, or other methods that have a very low chance of failure, to prevent pregnancy during the study.
You must agree to take ciprofloxacin (an antibiotic, which is medicine used to kill bacteria) twice a day for the first four weeks, or metronidazole if you cannot tolerate the first medicine.
You must stop any other antibiotic therapy (medicine used to treat bacterial infections) on the first day of the study.
You must have had a proctocolectomy and IPAA (surgeries where the colon and rectum are removed and replaced with an internal pouch) due to UC (Ulcerative Colitis, a type of long-term inflammation in the colon).
You must have chronic or recurrent pouchitis, which is ongoing or returning inflammation of the internal pouch.
Your condition must be confirmed by a mPDAI score of 5 or higher and a specific endoscopic subscore of 2 or higher, which are measurements used by doctors during a visual exam of the pouch to check the severity of inflammation.
You must meet one of the following: having at least two recurrent episodes (repeated flare-ups) of inflammation in the last year that required at least two weeks of medicine, or having taken maintenance antibiotic therapy (medicine taken regularly to prevent infection) for four weeks without success, or having previously tried and failed to improve with biologic therapy (a type of medicine made from living organisms used to treat complex diseases).

Who cannot join the trial?

18 criteria

Having Crohn’s disease, which is a long-term swelling of the digestive tract, or related problems like fistulas (unnatural tunnels between organs), strictures (narrowing of the intestine), or ulcerations (open sores) in the part of the intestine before the pouch.
Having irritable pouch syndrome, cuffitis (inflammation at the opening of the pouch), or infectious pouchitis (inflammation caused by an infection).
Having a diverting ostomy (a surgical way to divert waste from the body) or physical problems with the pouch.
Having a chronic infection with Hepatitis B or Hepatitis C (viruses that affect the liver), a known history of HIV (a virus that weakens the immune system), or being immunodeficient (having a weakened immune system due to organ transplants or other conditions).
Having a severe, active infection such as sepsis (a life-threatening reaction to infection), cytomegalovirus, listeriosis, or C. difficile (a type of bacterial infection).
Having an allergy or a medical reason not to take the medicines ciprofloxacin or metronidazole.
Having a current or past history of malignancy (cancer), unless it was a specific type of skin cancer or early-stage cervical cancer that was treated successfully.
Having a serious hypersensitivity (an extreme allergic reaction) to guselkumab or any of the other ingredients used to make the medicine.
Having any medical condition or abnormal laboratory results (test results) that the doctor believes could make participating in the study unsafe.
Taking any other medicines or treatments that could make participation unsafe or interfere with the study results.
Being pregnant, breastfeeding, or planning to become pregnant during the study or for 12 weeks after the last dose.
Women who plan to donate eggs or are of child-bearing age and are not using highly effective contraception (birth control).
Men who want to get their partner pregnant or plan to donate sperm during the study or for 12 weeks after the last dose.
Taking part in another clinical trial that uses an investigational medicinal product (a drug being tested) or a medical device.
Having previously used anti-IL12/23 or anti-IL23 antibodies (specific types of medicines that target parts of the immune system).
Using any experimental or approved biologic agent (medicines made from living organisms) within 30 days before the study begins.
Using JAK inhibitors (a type of medicine that blocks certain signals in the immune system) or other experimental therapies within 30 days before the study begins.
Having active tuberculosis (TB) or latent tuberculosis (a sleeping form of the TB infection that is not currently active).

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Guselkumab is a medication given as a shot under the skin. It is being studied to see how well it works at improving symptoms in people who have pouchitis that keeps coming back or does not respond well to other treatments.

Guselkumab

What is already known about the treatment

Guselkumab - This medication is administered as a single injection under the skin using a pre-filled syringe. It is currently used in medical practice to treat certain inflammatory skin conditions, but it is being studied here for its potential to treat pouchitis, an inflammation of the small pouch created during surgery. The drug works by targeting and blocking a specific protein in the body called interleukin-23, which helps to reduce the overactive immune response that causes inflammation. It belongs to a group of drugs known as monoclonal antibodies that help calm the immune system.

Investigated diseases

Pouchitis - This condition involves inflammation of the intestinal pouch that is surgically created after certain parts of the large intestine are removed. The inflammation can occur as an acute episode or develop into a chronic state. Symptoms typically involve changes in bowel habits and discomfort in the abdominal area. The disease may follow a pattern of relapsing, where symptoms reappear after an initial period of improvement. It often affects the lining of the pouch through various stages of irritation.