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

NCT04283864 | Active Not Recruiting

• 1 other identifier: 0722-19 -RMC
• Study Type: observational
• Target: 267
• Locations: 7 countries
• Sites: 8

Brief 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.

Conditions

Crohn Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Personalised nutrition Algorithm based on microbiome.

  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.

  3 years

Study Arms (3)

Group A

Newly onset Crohn's disease patients

Other: endoscopy examination

Group B

Children undergoing colonoscopy for non-specific abdominal pain or other non-inflammatory gastrointestinal conditions.

Other: endoscopy examination

Group C

Healthy individuals - not undergoing endoscopy

Interventions

endoscopy examination OTHER

endoscopic examination performed solely for clinical indications and not as part of the study procedures

Group A; Group B

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children between 6 to 18 years old. new onset crohn's disease patients( undergoing endoscopy) children without Crohn Disease ( undergoing endoscopy for non-specific abdominal pain) healthy children ( not undergoing endoscopy)

You may qualify if:

• 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 criteria)
• Between 6 and 18 years of age.
• 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
• 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.

You may not qualify if:

• CD study group
• Any known autoimmune or rheumatologic disease.
• Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
• Past or present history of malignancy.
• Primary immunodeficiency.
• Pregnancy in the last 6 months, breastfeeding.
• Morbid obesity (BMI \> 95th percentile for their age and gender).
• Following particular dietary regimen/dietitian consultation/participation in another study.
• 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.
• Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
• Gut-related surgery, including bariatric surgery.
• Inability of the participant and nuclear family to follow and utilize the smartphone application.
• Control group undergoing endoscopy:
• Any known autoimmune or rheumatologic disease.
• Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).

Sponsors & Collaborators

• Federico II University: collaborator
• Hospital Sant Joan de Deu: collaborator
• Stockholm South General Hospital: collaborator
• University of Alberta: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• Schneider Children's Medical Center, Israel: collaborator
• Children's Hospital Zagreb: collaborator
• Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC): collaborator
• Weizmann Institute of Science: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (8)

University of Alberta

Edmonton, Canada

Location

Children's Hospital Zagreb

Zagreb, Croatia

Location

Schneider children's medical center

Petah Tikva, Israel

Location

Dana-Dwek Children's Hospital

Tel Aviv, Israel

Location

University of Naples "Federico II"

Naples, 80131, Italy

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Hospital Sant Joan de Déu

Barcelona, Spain

Location

Sachs' Children and Youth Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Eran Elinav, Prof

  Weizmann Institute of Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Host-Microbiome Interaction Research Group

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: February 25, 2020
• Study Start: November 29, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); IT (1); CA (1); CR (1); NL (1); ES (1); SE (1)