Status:
RECRUITING
Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
Lead Sponsor:
Weizmann Institute of Science
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Crohn Disease
Eligibility:
All Genders
6-18 years
Brief Summary
The study is 3 arms observational study with no intervention that aims to understand the link between Crohn's disease, microbiome and diet in children. 150 children newly diagnosed with Crohn's disea...
Eligibility Criteria
Inclusion
- CD study group - 'Consent form - Part 1'
- Children with clinical suspicion for CD.
- Between 6 and 18 years of age.
- Naïve to any medical or nutritional intervention.
- CD study group - 'Consent form - Part 2'
- Children with CD confirmed by endoscopy (and based on accepted criteria7)
- Between 6 and 18 years of age.
- Naïve to any medical or nutritional intervention.
- Control group undergoing endoscopy en between 6 and 18 years of age undergoing colonoscopy for non-specific abdominal pain or other non-inflammatory gastrointestinal conditions.
- Control group not undergoing colonoscopy
- Children with no symptoms or signs of gastrointestinal disease and no known medical conditions.
- Children between 6 and 18 years of age. These children will be recruited from general pediatric clinics (children attending for routine check-up), orthopedic clinics, ophthalmology clinics or schools.
Exclusion
- CD study group
- Chronic treatment with any drug upon enrolment and the use of systemic antibiotics, probiotics or proton pump inhibitors during 30 days prior to enrollment.
- Morbid obesity (BMI \> 95th percentile for their age and gender).
- Following particular dietary regimen/dietitian consultation/participation in another study.
- Chronic use of steroids or immunomodulatory medications prior to CD diagnosis.
- Any other chronic disease (e.g. HIV, Cushing disease, acromegaly, hyperthyroidism, etc.), cancer and recent anti-cancer therapy, neuro-psychiatric disorders, coagulation disorders, celiac disease or any other chronic GI disorder.
- Gut-related surgery, including bariatric surgery.
- Inability of the participant and nuclear family to follow and utilize the smartphone application.
- Control group not undergoing colonoscopy
- Children with no symptoms or signs of gastrointestinal disease and no known medical conditions.
- Children between 6 and 18 years of age. These children will be recruited from general pediatric clinics (children attending for routine check-up), orthopedic clinics, ophthalmology clinics or schools.
- Control group undergoing endoscopy
- Any known chronic illness.
- Following particular dietary regimen/dietitian consultation/participation in another study.
- Chronic treatment with any drug upon enrolment and the use of systemic antibiotics, probiotics or proton pump inhibitors during 30 days prior to enrollment.
- Gut-related surgery, including bariatric surgery.
Key Trial Info
Start Date :
November 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04283864
Start Date
November 29 2020
End Date
December 1 2025
Last Update
July 16 2025
Active Locations (2)
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1
Schneider children's medical center
Petah Tikva, Israel
2
University of Naples "Federico II"
Naples, Italy, 80131