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

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ClinicalTrials.gov Identifier: NCT04283864
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Eran Elinav, Weizmann Institute of Science

Brief Summary:

The study is 3 arms observational study with no intervention that aims to understand the link between Crohn's disease, microbiome and diet in children.

150 children newly diagnosed with Crohn's disease will participate in the study and their data will be used to create an algorithm about their microbiome, disease, diet, etc.

100 other children newly diagnosed will participate in the study and their data will be use to validate the algorithm.

The investigators will be recruiting 50 healthy participants: 20 that are undergoing an endoscopy for abdominal pain and 30 that comes to the physician for different reasons.

After parental consent, the participants will receive an explanation of the study and sign a consent form for colonoscopy. Before colonoscopy, participants will bring fecal samples, give blood samples, biopsies and biopsy brushes (superficial scraping of the tissue) will be taken during the operation. These samples will be retained until further consent is obtained for further study.

After receiving the results of the colonoscopy, children who have been diagnosed with Crohn's disease will be offered to participate in the second part of the study, they will receive an explanation about the app, collection of fecal samples at home, diet logs and anthropometric measurements, demographic information, medical and family history will be registered.

During the first 3 months: the participants will be asked to log data in the app and collect fecal samples at home. They will be asked to come for a follow up visit where anthropomorphic measurements and blood samples will be taken.

Participants will be asked to log in every day to report in the app daily activity and food intake throughout the study period. Each week, the research coordinator will call on participants to make sure the app is correctly filled in, collect the stool samples correctly and answer questions. During the entire study participants will collect fecal samples, every first week of the month participants will enter information in the app.

For children who have not been diagnosed with Crohn's disease by the colonoscopy, or children who visit the institute for reasons other than inflammatory bowel disease without a clear finding will participate in the study control group. If consent is given, fecal samples will be collected at the entrance of the study and after one year, blood samples, a food questionnaire and anthropometric indices, demographic information, medical and family history will be completed.


Condition or disease
Crohn Disease

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort
Group A
Group B
Group C



Primary Outcome Measures :
  1. Personalised nutrition Algorithm based on microbiome. [ Time Frame: 3 years ]
    Using machine learning we will create a trained personalised decision-tree based predictor enabling a significant prediction of nutritional impacts on CD clinical and inflammatory features during the first year of follow-up. It will be based on information gathered from microbiome ( metagenomic and 16s sequencing of stool microbiome), nutritional questionnaire and disease states (via fecal calprotectin test) in children with Crohn's disease.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283864


Contacts
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Contact: Aurelie Bukimer +972542477540 aurelie.bukimer@weizmann.ac.il

Sponsors and Collaborators
Weizmann Institute of Science
The Leona M. and Harry B. Helmsley Charitable Trust
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Responsible Party: Eran Elinav, Principal Investigator, Host-Microbiome Interaction Research Group, Weizmann Institute of Science
ClinicalTrials.gov Identifier: NCT04283864    
Other Study ID Numbers: 0722-19 -RMC
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eran Elinav, Weizmann Institute of Science:
Crohn Disease
microbiome
Personal diet
personalized nutrition
Nutribiome
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases