Trial Eligibility Check

Inflammatory Bowel Disease

How do clinical trials fit into the treatment of inflammatory bowel disease?
Gastrointestinal diseases

Quite a few patients suffering from inflammatory bowel disease, including Ulcerative Colitis and Crohn’s disease, are forced to go through different lines of treatment throughout their illness after which previous lines of treatment have not resulted in the expected benefit. You may have experienced for yourself a minimal response to the treatments available today or suffered from severe side effects. However, for patients like you, clinical trials can allow access to more advanced treatment lines, after they have already proven initial safety and efficacy – free of charge.

As patients suffering from inflammatory bowel disease, the daily abdominal pain, the worry of staying close to toilets, and the feeling of discomfort that accompanies it in social situations, can often be challenging, difficult, and even frustrating.

Prolonged abdominal pain may be accompanied by multiple diarrhea – sometimes even dozens of times a day. Diarrhea can be accompanied by bleeding or mucus, and many patients suffer from difficulty in controlling their sphincters when they suffer from diarrhea attacks (1).

For a significant proportion of patients, abdominal pain may lead to a decrease in appetite. Along with increased bowel movements and inflammation in the gut, patients suffer from significant weight loss and nutritional deficiencies. You may also have experienced joint pain, eye infections, and other inflammatory symptoms outside the gut (2).

1. Key facts

 

 

Over 40,000 Israeli men and women suffer from inflammatory bowel disease (IBD) – (3).

The two main inflammatory bowel diseases are Ulcerative Colitis and Crohn’s disease.

Ulcerative Colitis causes recurrent bouts of inflammation in the colon.

Crohn’s disease can involve different and multiple areas throughout the digestive tract.

Characterized by a young age, patients suffer from recurrent seizures throughout their lives.

Many of the patients need continuous treatments for long periods.

Quite a few of existing treatments are not free of side effects (4).

Clinical trials can allow access to more advanced treatment lines, having already demonstrated initial safety and efficacy, free of charge – Check your eligibility here.

2. Diagnosis
Diagnosis and follow-up of inflammatory bowel disease

Diagnosis of inflammatory bowel disease is usually made after examination of the gastrointestinal tract with the help of a camera – gastroscopy (insertion of a tube with a camera through the mouth) or colonoscopy (through the anus). Follow-ups and treatments are associated with gastroenterological specialists (Gastroenterologist) (5).

To assess the severity of the disease – mild, moderate, or severe – doctors use medical questionnaires. These questionnaires assess the medical symptoms mentioned above and their frequency, along with various laboratory tests that indicate inflammatory and metabolic processes (i.e., related to the nutritional balance).

The questionnaires provide a score that allows, among other things, to measure severity and exacerbations of the disease, and to make medical decisions about the type of treatment needed – as well as to assess the response to treatment (6).

According to data published by the Association for the Support of Crohn’s and Ulcerative Colitis Patients, over 40,000 Israelis suffer from inflammatory bowel disease (IBD).

3. Treatments

There are many treatment lines for inflammatory bowel disease, in part because their effectiveness varies between patients and they themselves may be associated with side effects. As mentioned, treatment lines often rely on the severity of the disease: mild, moderate, or severe. These grades are based not only on laboratory measures but also on the severity of the symptoms experienced by the patient, and their frequency (7).

Common to the treatment lines is the suppression of the inflammatory process, which is the basis behind the two diseases. The difference is in the intensity of the inflammatory suppression, which often also involves the suppression of the immune system. Immune suppression in itself weakens the body’s ability to cope with various diseases, especially infectious diseases.

Treatment of ulcerative colitis

In mild ulcerative colitis, you can start with topical medications (by swallowing a pill or injection) such as the drug Mesalamaine, known under the trade name Rapasel ®. In addition, some patients experience initial relief of symptoms with the help of steroids, which are usually limited in scope due to side effects caused by prolonged treatment (8).

In moderate or severe colitis – that is, in severe diarrhea or severe inflammatory indices – more “advanced” treatments are required. Some include biological therapies such as adalimumab (Yomira®), Vedolizumab (Antibio®), or Ustekinumab (Stella®).

Biological therapies include more advanced and “sophisticated” drugs that respond with the biological properties of the body’s immune cells, to affect their function. Some treatments include expensive medications that can only be obtained through an infusion at the hospital. Some severe cases remain stubborn until it is necessary to arrive at the resection of the inflamed bowel (9).

Crohn’s disease treatment

Crohn’s patients, who are on the same spectrum of inflammatory bowel disease along with ulcerative colitis, can suffer from the symptoms of the disease not only throughout the gastrointestinal tract – from oral absorption disorders to the involvement of the rectum (rectum) and anus (rape) – but also from Inflammatory symptoms elsewhere in the body.

Similar to ulcerative colitis, the cornerstones of Crohn’s treatment also rely on immunosuppression in the form of steroids and biological therapies in moderate and severe cases of Crohn’s. Crohn’s patients who do not respond to biological therapies are often transferred to immunosuppressive drugs – including Azathioprine (Imuran ®) or Methotrexate ®.

Both biological and immunosuppressive therapies often expose patients to an increased risk of various infections, as well as to a variety of side effects unique to each drug – especially with long-term treatment (10).

In the absence of a complete cure for inflammatory bowel disease, many patients need ongoing treatments for long periods. Quite a few of these treatments are not free of side effects. This is why clinical trials may be a good solution for them – I want to check my clinical trial options.

4. Next steps
After exhausting all the treatment lines – what is the next step?

New drugs and other treatments are constantly being tested before entering the market as part of clinical trials.

Before new drugs are widely approved (and sometimes even entered the drug reimbursement list), it must be proven that they are indeed safe and effective for the disease with the help of clinical research.

  • You can read more about clinical trials and how they are conducted on our site.

Patients with inflammatory bowel disease may benefit from participating in a clinical trial, by accessing advanced therapies that are not otherwise accessible.

Participating in a clinical trial can suit a variety of patients – you may too.

Clinical studies are most often looking for patients who do not respond well to medications currently on the market, as well as patients who are unable to withstand the side effects of current medications. What these patients have in common is that they need an alternative, better treatment for their chronic illness. If you have experienced any of these, a clinical trial may be the next step for you.

Participating in a clinical trial can suit you – Check my clinical trial eligibility!

5. Clinical trials

Clinical studies in Israel for IBD

Every year, many clinical studies are conducted in Israel that examine different treatments for different diseases; Of these, there are also clinical trials for IBD. To check your suitability for participation in one of these studies click here.

Clinical studies are examining the effect of new drugs on inflammatory bowel disease – both during acute attacks and in order to keep the disease “quiet” for a long time between attacks. The goal is to improve the quality of life of patients, which is often impaired due to the symptoms of the disease and the side effects of the treatment.

Participating in clinical research can help not only you but also other patients and Science. To better understand what clinical trials are currently underway for new drugs for inflammatory bowel disease in Israel, whether these studies may be right for you, and what are the pros and cons of participating in such studies, you can fill out our medical questionnaire. If we find you a suitable clinical trial, your information will be passed on to the doctor who is conducting the study, so that they can answer your questions and help you decide whether to participate in the trial or not.