Understanding how diet and microbiome affect Crohn's disease in children

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

This study is trying to see how diet and gut bacteria affect children with Crohn's disease to help create better nutrition plans for them.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 6 Years to 18 Years
• Sex: All
• Sponsor: Weizmann Institute of Science (Academic / other)
• Locations: 2 sites (Petah tikva and 1 other locations)
• Trial ID: NCT04283864 on ClinicalTrials.gov

What this trial studies

This observational study involves 150 children newly diagnosed with Crohn's disease and aims to explore the relationship between their microbiome, diet, and clinical features. Participants will provide fecal and blood samples, and undergo endoscopy to gather data that will be used to develop an algorithm linking these factors. An additional 100 children will help validate this algorithm, while 50 healthy participants will serve as controls. The study seeks to enhance understanding of Crohn's disease and its management through personalized nutrition.

Who should consider this trial

Good fit: Ideal candidates include children aged 6 to 18 who are newly diagnosed with Crohn's disease and have not received any prior medical or nutritional interventions.

Not a fit: Patients with chronic treatment for Crohn's disease or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized dietary recommendations that improve health outcomes for children with Crohn's disease.

How similar studies have performed: While studies exploring the microbiome and diet in Crohn's disease exist, this specific approach of combining personalized nutrition with microbiome analysis in children is relatively novel.

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.

Where this trial is running

Petah tikva and 1 other locations

• Schneider children's medical center — Petah tikva, Israel (Recruiting)
• University of Naples "Federico II" — Naples, Italy (Recruiting)

Study contacts

• Principal investigator: Eran Elinav, Prof — Weizmann Institute of Science
• Study coordinator: Aurelie Bukimer

Conditions Crohn Disease; microbiome; Personal diet; personalized nutrition; Nutribiome