Clinical trial for Crohn's Disease (CD)
Official title Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study
ClinicalTrials.gov ID: NCT07522528
What this study is testing
- What it's testing
- Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18. Healthy volunteers may be eligible.
You may be able to join if
- Eligible participants to the RCT are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's...
- Eligible participants to the observational cohorts are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted...
You likely can't join if
- Inability to provide consent to participate in the study (i.e., this applies to young adults (aged 16-18 years) who are old enough but unable to...
- Presence of stoma or of short bowel syndrome.
- Patients currently receiving oral or intravenous steroids at a dosage \>20mg/day prednisolone or \>9mg/day budesonide.
- Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background immunomodulator (azathioprine...
- CD with a major fistulising or symptomatic fibrotic stricturing phenotype.
- Patients with comorbid anorexia nervosa.
See the full eligibility criteria
- Eligible participants to the RCT are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin...
- Eligible participants to the observational cohorts are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a...
- Inability to provide consent to participate in the study (i.e., this applies to young adults (aged 16-18 years) who are old enough but unable to provide consent and carers (of children aged 6-15 years old) who are...
- Presence of stoma or of short bowel syndrome.
- Patients currently receiving oral or intravenous steroids at a dosage \>20mg/day prednisolone or \>9mg/day budesonide.
- Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks.
- CD with a major fistulising or symptomatic fibrotic stricturing phenotype.
- Patients with comorbid anorexia nervosa.
- Any clinical contraindication to use of exclusive enteral nutrition or partial enteral nutrition.
- Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C.
- Patients with untreated tuberculosis (latent or active).
- Current enrolment in other studies of an investigational product or dietary intervention.
- Food allergies, which do not permit participation in the study (e.g., cow's milk allergy).
- Pregnant and/or breastfeeding individuals.
The study team makes the final eligibility decision.
Where it is enrolling
- Edinburgh, United Kingdom
- Glasgow, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Edinburgh, United Kingdom; Glasgow, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.