Inflammatory Bowel Disease
What is Inflammatory Bowel Disease?
IBD is a chronic, autoimmune disease, encapsulating both Crohn’s Disease (CD) and Ulcerative Colitis (UC) in which the gastrointestinal tract is affected by inflammation. While most people with IBD are diagnosed between the ages of 15 to 35, persons of any age and gender are affected with over 40,000 people in Ireland living with IBD.
Ulcerative Colitis
Ulcerative colitis (UC) affects only the inner lining of the large bowel (colon). Small ulcers can develop on the colon's lining, and can bleed and produce pus.
Crohn's Disease
Crohn’s Disease (CD) can affect any part of the digestive system from the mouth to the anus and may involve the full thickness of the intestine wall.
As Crohn's disease can affect any part of the gastrointestinal tract, the symptoms of Crohn's disease depend on the part of the gastrointestinal tract affected by the disease.
Stomas
Colostomy: part of your large bowel or colon is pulled through from an incision made on your abdomen to form a stoma
Ileostomy: part of your small bowel (the ileum) is pulled through an incision made on your abdomen to form a stoma
References
Crohn’s & Colitis Ireland, https://crohnscolitis.ie
NHS, https://www.nhs.uk
Crohn’s Colitis Foundation, https://www.crohnscolitisfoundation.org
Bladder & Bowel Community, https://www.bladderandbowel.org
Clinical Research
Clinical Trials
Our network will mostly participate in Phase II, III, and IV clinical trials, observational studies, and retrospective studies. The research teams that you will meet during these studies will usually consist of consultant gastroenterologists, research nurses, IBD nurses, and research coordinators.
Clinical trials involve testing a new drug to examine how effective it is at treating the target disease, and also to identify any side effects. A drug will go through four phases of trials
Phase I
Phase I trials will test the safety of a new drug, looking at any side effects that occur at different doses. These trials usually involve a small number of healthy volunteers (around 20-100) and will last several months.
Phase II
Phase II trials test new drugs that have passed Phase I trials in larger groups of people (around 100-300) who have an illness, e.g. IBD, to see if it shows signs of being an effective treatment. In this phase researchers will also examine possible side effects and try to establish the right dose of the drug to administer to patients. Phase II trials usually last up to 2 years.
Phase III
If Phase I and II trials suggest the new drug may be effective, the drug will enter Phase III trials. Phase III trials compare new drugs with either a medication that is currently in use or with no drug treatment at all. They can last a year or more longer than Phase II trials. Usually, large number of patients (1,000-3,000) in different countries will participate in a Phase III trial.
Phase IV
Phase IV studies are carried out after a drug has been approved and are designed to evaluate the long term effects of the drug as well as to continue looking for any previously unidentified side-effects. These trials will usually involve several thousand participants and will last for one or more years.
Observational Studies
In an observational study, researchers will observe patients who are already receiving a certain drug or treatments and compare them to a group who are receiving a different treatment or no treatment at all. This may be to look at the effect of a drug on a disease over time or to analyse the safety of a drug with continued use. Depending on the study protocol, the patient may have to fill in a diary or questionnaires over a certain period of time tracking their disease, medications, and general well-bring.
Retrospective Studies
In a retrospective study, researchers will look at the drugs or treatments that a group of people have received in the past. They will examine how the patient was while they were taking the treatment to determine if it poses any risk or if it has a protective effect. This may involve looking at medical records or asking the patient questions. This type of study will involve the least patient participation as information is mostly gathered through documents and records from the past.
Advantages of Research
For Research and Treatment
- Improves access to new medications and treatments
- Provides information on safety and effectiveness
- Looks into how treatments work in a real world setting
- Furthers understanding about both Crohn’s and Colitis
For Patients
- New treatments before they are widely available to the public
- Help further research on additional treatments
- Treatment costs may decrease- pharmaceuticals companies will cover costs of medication in some interventional studies