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Scientists decode how food and microbes shape Crohn's in kids

NCT ID NCT04283864

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 300 children to understand how diet, gut bacteria, and Crohn's disease interact. Researchers will collect stool, blood, and tissue samples, plus daily food logs via an app. The goal is to build a personalized algorithm that predicts how diet affects inflammation and symptoms in children with Crohn's.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to personalized dietary recommendations that help manage Crohn's disease in children.
What could go wrong
This is an observational study, not a treatment trial. The algorithm may not work for everyone or may take years to develop into practical advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Children between 6 to 18 years old. 250 with crohn disease ( undergoing endoscopy) 20 children without Crohn Disease ( undergoing endoscopy) 30 healthy children ( not undergoing endoscopy)

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Schneider children's medical center

    Petah Tikva, Israel

  • University of Naples "Federico II"

    Naples, 80131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.