Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease

Launched by WEIZMANN INSTITUTE OF SCIENCE · Feb 23, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how nutrition, gut bacteria (known as the microbiome), and individual characteristics affect children with Crohn's disease, a chronic condition that causes inflammation in the intestines. The study will involve 150 children who have just been diagnosed with Crohn's disease, and their information will help researchers create a tool to better understand the links between diet and gut health. An additional 100 children will help test this tool to ensure it works correctly. There will also be a control group of 50 healthy children who will provide comparison data.

To participate, children must be between 6 and 18 years old and newly diagnosed with Crohn's disease or undergoing testing for other abdominal issues. Participants will provide samples of their stool and blood, and some will have a procedure called a colonoscopy to look at their intestines. Over the course of three months, they will track their food intake and daily activities using a smartphone app. Researchers will check in regularly for support and to collect more information. This study aims to provide valuable insights into how diet and gut bacteria can influence the health of children with Crohn's disease, which may lead to better management of the condition in the future.

Gender

ALL

Eligibility criteria

• 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 criteria7)
• • 2. Between 6 and 18 years of age.
• • 3. 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
• • 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. Chronic treatment with any drug upon enrolment and the use of systemic antibiotics, probiotics or proton pump inhibitors during 30 days prior to enrollment.
• • 2. Morbid obesity (BMI \> 95th percentile for their age and gender).
• • 3. Following particular dietary regimen/dietitian consultation/participation in another study.
• • 4. Chronic use of steroids or immunomodulatory medications prior to CD diagnosis.
• • 5. 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.
• • 6. Gut-related surgery, including bariatric surgery.
• • 7. Inability of the participant and nuclear family to follow and utilize the smartphone application.
• • 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.
• • Control group undergoing endoscopy
• • 1. Any known chronic illness.
• • 2. Following particular dietary regimen/dietitian consultation/participation in another study.
• • 3. Chronic treatment with any drug upon enrolment and the use of systemic antibiotics, probiotics or proton pump inhibitors during 30 days prior to enrollment.
• • 4. Gut-related surgery, including bariatric surgery.