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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
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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alberta
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Hospital Sant Joan de Déu
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Children's Hospital Zagreb
Coordinator of this site? Confirm its status
ZagrebCroatiaUnknown status
Schneider Children's Medical Center
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
Dana-Dwek Children's Hospital
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
University of Naples Federico II
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
Amsterdam UMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Sachs' Children and Youth Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.