endoscopy examination: endoscopic examination performed solely for clinical indications and not as part of the study procedures
Study summary
This is a three-arm, non-interventional observational study designed to investigate the relationship between Crohn's disease (CD), the microbiome, and diet in children.
Eligibility
Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* CD study group - 'Consent form - Part 1'
1. Children with clinical suspicion for CD.
2. Between 6 and 18 years of age.
3. Naïve to any medical or nutritional intervention.
CD study group - 'Consent form - Part 2'
1. Children with CD confirmed by endoscopy (and based on accepted criteria)
2. Between 6 and 18 years of age.
3. Naïve to any medical or nutritional intervention.
Control group undergoing endoscopy children 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
1. Children with no symptoms or signs of gastrointestinal disease and no known medical conditions.
2. 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 Criteria:
* CD study group
1. Any known autoimmune or rheumatologic disease.
2. Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
3. Past or present history of malignancy.
4. Primary immunodeficiency.
5. Pregnancy in the last 6 months, breastfeeding.
6. Morbid obesity (BMI \> 95th percentile for their age and gender).
7. Following particular dietary regimen/dietitian consultation/participation in another study.
8. Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
9. Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
10. Gut-related surgery, including bariatric surgery.
11. Inability of the participant and nuclear family to follow and utilize the smartphone application.
Control group undergoing endoscopy:
1. Any known autoimmune or rheumatologic disease.
2. Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
3. Past or present history of malignancy.
4. Primary immunodeficiency.
5. Pregnancy in the last 6 months, breastfeeding.
6. Morbid obesity (BMI \> 95th percentile for their age and gender).
7. Following particular dietary regimen/dietitian consultation/participation in another study.
8. Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
9. Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
10. Gut-related surgery, including bariatric surgery.
Control group not undergoing colonoscopy:
1. Any known autoimmune or rheumatologic disease.
2. Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
3. Past or present history of malignancy.
4. Primary immunodeficiency.
5. Pregnancy in the last 6 months, breastfeeding.
6. Morbid obesity (BMI \> 95th percentile for their age and gender).
7. Following particular dietary regimen/dietitian consultation/participation in another study.
8. Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
9. Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
10. Gut-related surgery, including bariatric surgery.
Primary outcome measure(s)
Personalised nutrition Algorithm based on microbiome. — 3 years Using a machine learning algorithm we will create a trained personalized predictor enabling to devise tailor-made dietary regimens to induce remission in pediatric CD using big data, which will be accumulated over a period of one year since disease onset. Personalized features will include: microbiome ( metagenomic sequencing of stool microbiome), blood tests, nutritional questionnaires and dietary logs, and disease states (via fecal calprotectin test) in children with Crohn's disease.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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