Crohn DiseaseNCT04283864
Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
An observational study of Crohn Disease, run by Weizmann Institute of Science at 8 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- endoscopy examination
- How many people
- 267 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 29 Nov 2020to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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)
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.).
- 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.
- Control group not undergoing colonoscopy:
- 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.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Israel2 sites
Schneider children's medical center
Petah Tikva
Dana-Dwek Children's Hospital
Tel Aviv
About this study
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.
Read the detailed description
This is an international, multi-center observational study conducted at eight sites worldwide: Israel, Italy, Croatia, Spain, Sweden, the Netherlands, and Canada.
The study is designed to recruit a large cohort of children with newly diagnosed Crohn's disease (CD), as well as two control groups: healthy controls undergoing colonoscopy for non-specific abdominal pain and non-invasively characterized healthy controls. Participants are recruited across the participating sites and followed for a period of one year.
During clinical visits, blood samples will be collected, anthropometric measurements will be obtained, and participants will be assessed by the study physician. Brushings and biopsies will be collected during endoscopic examinations performed solely for clinical indications and not as part of the study procedures.
During the one-year follow-up period, participants will be asked to collect stool samples at home for assessment of microbiome composition and perform home fecal calprotectin tests. Participants will also be asked to continuously record their daily activities and dietary intake using a smartphone application.
The study aims to leverage the large-scale dataset collected to determine how individualized factors, particular in order to devise a personalized dietary interventions for pediatric patients with Crohn's disease.
- Conditions
- Crohn Disease
- Being tested
- endoscopy examination
- Keywords
- Crohn Disease, microbiome, Personal diet, personalized nutrition, Nutribiome
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopy examinationOther
endoscopic examination performed solely for clinical indications and not as part of the study procedures
| Study group | Role | What they receive |
|---|---|---|
| Group A | Newly onset Crohn's disease patients Receives: Other: endoscopy examination | |
| Group B | Children undergoing colonoscopy for non-specific abdominal pain or other non-inflammatory gastrointestinal conditions. Receives: Other: endoscopy examination | |
| Group C | Healthy individuals - not undergoing endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start29 Nov 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Schneider Children's Medical Center, Israel, Federico II University, Hospital Sant Joan de Deu, Children's Hospital Zagreb, Stockholm South General Hospital, Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC), University of Alberta, Tel-Aviv Sourasky Medical Center
- Responsible party
- Principal investigator, Eran Elinav, Weizmann Institute of Science
- Investigators
- Eran Elinav, Prof, Principal investigator, Weizmann Institute of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283864
- Sponsor's protocol ID
- 0722-19 -RMC
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2019
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04283864
- Acronym / sponsor ID
- 0722-19 -RMC
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, microbiome, Personal diet, personalized nutrition, Nutribiome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Schneider Children's Medical Center, Israel, Federico II University, Hospital Sant Joan de Deu, Children's Hospital Zagreb, Stockholm South General Hospital, Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC), University of Alberta, Tel-Aviv Sourasky Medical Center
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an international, multi-center observational study conducted at eight sites worldwide: Israel, Italy, Croatia, Spain, Sweden, the Netherlands, and Canada.
The study is designed to recruit a large cohort of children with newly diagnosed Crohn's disease (CD), as well as two control groups: healthy controls undergoing colonoscopy for non-specific abdominal pain and non-invasively characterized healthy controls. Participants are recruited across the participating sites and followed for a period of one year.
During clinical visits, blood samples will be collected, anthropometric measurements will be obtained, and participants will be assessed by the study physician. Brushings and biopsies will be collected during endoscopic examinations performed solely for clinical indications and not as part of the study procedures.
During the one-year follow-up period, participants will be asked to collect stool samples at home for assessment of microbiome composition and perform home fecal calprotectin tests. Participants will also be asked to continuously record their daily activities and dietary intake using a smartphone application.
The study aims to leverage the large-scale dataset collected to determine how individualized factors, particular in order to devise a personalized dietary interventions for pediatric patients with Crohn's disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: endoscopy examinationNewly onset Crohn's disease patients |
| Group B | – | Other: endoscopy examinationChildren undergoing colonoscopy for non-specific abdominal pain or other non-inflammatory gastrointestinal conditions. |
| Group C | – | –Healthy individuals - not undergoing endoscopy |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (12 listed)
- CD study group - 'Consent form - Part 1'
- 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.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopy examinationendoscopic examination performed solely for clinical indications and not as part of the study procedures | Other | Group A, Group B |
Primary outcome
Personalised nutrition Algorithm based on microbiome.
Time frame: 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Elinav, Prof principal investigator
Weizmann Institute of Science
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Weizmann Institute of Science at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel, Canada, Croatia, Italy, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personalised nutrition Algorithm based on microbiome. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.