A study to learn if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet
Many people with coeliac disease still experience painful or disruptive symptoms—such as bloating, diarrhoea, and stomach cramps—even when following a strict gluten-free diet. This is often caused by tiny, accidental traces of gluten in everyday food. This clinical trial is testing an experimental medicine called ZED1227. Researchers want to find out whether taking this daily capsule can shield the lining of the gut from damage and stop symptoms when gluten is accidentally eaten. Participants will take either ZED1227 or a dummy capsule (placebo) once a day and eat a snack bar containing a small amount of gluten three times a week. The study lasts about 23 weeks and includes seven clinic visits, health checks, an electronic symptom diary, and two camera tests (endoscopies) to inspect the gut lining. Taking part is completely voluntary.
במבט חטוף
על מה המחקר הזה?
Coeliac disease is a lifelong condition where the body's immune system attacks the lining of the small bowel whenever gluten—a protein found in wheat, barley, and rye—is eaten. At present, the only way to manage it is to follow a strict gluten-free diet. However, even when people try their hardest, tiny hidden traces of gluten in restaurant meals or packaged foods can trigger inflammation and cause ongoing symptoms like bloating, stomach pain, and tiredness.
Researchers are developing a new capsule called ZED1227 to help solve this problem. The drug works by blocking an enzyme in the gut that triggers inflammation when gluten is present. The goal of this study is to see if ZED1227 can protect the bowel lining and reduce symptoms when small amounts of gluten enter the body.
To find out if the treatment works, the study compares ZED1227 to a 'placebo'. A placebo looks identical to the real medicine but contains no active ingredients. Comparing the study drug against a placebo helps scientists prove whether any improvements in health, or any side effects, are truly caused by ZED1227.
נקודות עיקריות
- Testing a new capsule (ZED1227) designed to protect the gut from accidental gluten.
- For adults aged 18 to 80 with coeliac disease who still have symptoms on a gluten-free diet.
- Participants take a daily capsule and eat a gluten snack bar three times a week.
- Involves seven clinic visits, an electronic symptom diary, and two camera tests (endoscopies) over 23 weeks.
- Participation is voluntary, and you can withdraw at any point.
מי עשוי להיות זכאי?
This study is open to adults aged 18 to 80 who have a medically confirmed diagnosis of coeliac disease. You must have been following a strict gluten-free diet for at least 12 months, but still experience moderate to severe digestive symptoms, such as regular stomach pain, bloating, sickness, or diarrhoea.
To qualify, your body mass index (BMI) needs to be between 17 and 35, and a bowel check must confirm that your gut still shows signs of coeliac disease. Women of childbearing age must not be pregnant and must agree to use an effective method of birth control throughout the study.
You cannot take part if you have a known allergy to wheat or other ingredients in the test snack bars, a recent stomach bug such as Helicobacter pylori, or other significant medical conditions that might make participation unsafe.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- You are between 18 and 80 years old.
- You have had a confirmed coeliac disease diagnosis for at least one year.
- You have followed a gluten-free diet for at least 12 months.
- You still regularly suffer from bloating, tummy pain, nausea, or diarrhoea.
- You are comfortable eating a snack bar with a small amount of gluten three times a week.
מה כרוך בהשתתפות?
Taking part lasts around 23 weeks and involves roughly seven visits to a hospital or study clinic. You will be randomly assigned by a computer to take either ZED1227 capsules or placebo capsules once a day with food. Neither you nor your study doctor can choose which group you join. To see how well the medicine protects against accidental gluten, you will also be asked to eat a provided snack bar containing a small amount of gluten three times a week.
At your visits, the medical team will check your health, collect blood and urine samples, and ask about your symptoms. You will also have two upper endoscopies—one near the beginning and one at the end of the trial. During an endoscopy, a thin, flexible camera is passed down your throat to look at your bowel lining and take tiny tissue samples (biopsies). Between visits, you will keep a quick daily diary on a mobile phone or computer to track your capsules and any symptoms.
סיכונים ותועלות פוטנציאליים
מיקומים (7)
- Royal Hallamshire HospitalמשוערSheffield, England
- Synexus Wales Clinical Research Centreעיר בלבדCardiff, Wales
- Synexus Manchester Clinical Research Centreעיר בלבדמנצ'סטר, אנגליה
- Synexus Merseyside Clinical Research Centreעיר בלבדLiverpool, England
- Synexus North East Clinical Research Centreעיר בלבדHexham, England
- John Radcliffe Hospitalלא מאומתOxford, England
- Synexus Scotland Clinical Research Centreלא מאומתBellshill, Scotland
שאלות נפוצות
מהו פלצבו?
A placebo is an inactive dummy pill that looks just like the real medicine. It allows doctors to see whether changes in your health are genuinely caused by the drug being tested.
Will I have to eat gluten during the trial?
Yes. You will be asked to eat a specially made snack bar containing a small amount of gluten three times a week to see if the medicine protects your gut from accidental exposure.
Is the endoscopy painful?
An endoscopy can feel uncomfortable, but it is not usually painful. The clinic team will offer you a numbing throat spray or a mild sedative to help you stay relaxed.
כמה זמן אהיה במחקר?
Participation lasts about 23 weeks in total and involves seven appointments at the clinic.
Can I leave the study if my symptoms become too uncomfortable?
Yes. You are completely free to leave the trial at any point, for any reason, and your usual NHS care will continue as normal.
כיצד לגלות עוד
Beate Niemeier
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
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