NCT04283864Active, not recruiting
Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 267 (actual)
- First submitted
- 19 Nov 2019
- Start date
- 29 Nov 2020
- Primary completion date
- Dec 2026
- Lead sponsor
- Weizmann Institute of Science
- Diseases
- Crohn's disease
- NCT number
- NCT04283864
What you commit to
- Study type: Observational
- Participants enrolled: 267
- From 29 Nov 2020 to the primary completion date, Dec 2026
- 8 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Control group not undergoing colonoscopy:
- 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.
Other illness
- 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.
- 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.
Age
- 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:
- Morbid obesity (BMI \> 95th percentile for their age and gender).
- Morbid obesity (BMI \> 95th percentile for their age and gender).
Other
- Primary immunodeficiency.
- Pregnancy in the last 6 months, breastfeeding.
- Following particular dietary regimen/dietitian consultation/participation in another study.
- Primary immunodeficiency.
- Pregnancy in the last 6 months, breastfeeding.
- Following particular dietary regimen/dietitian consultation/participation in another study.
Who the study is looking for
- 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.
Age in the registry: 6 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Hospital Sant Joan de Déu Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Children's Hospital Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Dana-Dwek Children's Hospital Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| University of Naples Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Sachs' Children and Youth Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.