Crohn's DiseaseNCT02930564
The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
A study testing CDED + milk fat and gluten in people with Crohn's Disease, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The Challenge study is a prospective, open label, pilot trial in patients in deep remission on dietary maintenance therapy. The purpose of this study is to determine whether they can consume some of the products that were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to evaluate if… Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- CDED + milk fat and gluten
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to 29 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Established diagnosis of Crohn's disease.
- Patients in sustained remission with PCDAI 0 > 6 months
- Ages 8-20
- Normal CRP (CRP<0.5), normal Calprotectin (<100)
- Patients with uncomplicated disease
- Signed informed consent
Who cannot join
- Patients with active disease (PCDAI >10)
- Pregnancy
- Patients with complicated disease (B2, B3)
- Patients with recent onset use of an immunomodulator <12 weeks, or dose change in past 12 weeks.
- Patients with current use of biologics.
- Elevated CRP or Calprotetcin>100 at screening.
Trial locations and contacts
1 site in 1 country.
About this study
The Challenge study is a prospective, open label, pilot trial in patients in deep remission on dietary maintenance therapy.
The purpose of this study is to determine whether they can consume some of the products that were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to evaluate if low dose exposure is harmful.
Read the detailed description
The investigators have previously hypothesized that Crohn's disease may occur via a sequence of events involving dysbiosis and genetically determined or environmentally acquired defects in innate immunity, and have further hypothesized that the mechanism of EEN for induction of remission acts by reducing exposure to dietary components that may cause an acquired bacterial clearance defect or generate dysbiosis.
Based on this premise, the investigators developed a new exclusion diet. This diet, named the Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. This diet was evaluated for induction of remission through week 12 and succeeded in inducing remission in 70% of 47 selected patients.
The investigators have now progressed to three randomized controlled trials to evaluate the diet in different populations with different disease severity, and the results from the first RCT demonstrate a high remission rate in the CDED arm. However , to date the investigators have used the same diet for all patients. The investigators are now encountering patients on the diet in deep remission, but the investigators do not know if they can consume some of the products ( such as milk fat and gluten) that were eliminated. The investigators therefore are starting to challenge our patients in deep remission with low dose exposure to evaluate if low dose exposure is harmful. The investigators wish to document this and obtain stool samples for calprotetctin and microbiome to investigate these patients at a microbiological level as well.
- Conditions
- Crohn's Disease
- Being tested
- CDED + milk fat and gluten
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDED + milk fat and glutenOther
Also called Crohn's Disease Exclusion Diet (CDED)
CDED phase 1- induction phase a milk fat /emulsifier challenge (one scoop of ice cream and one slice of yellow processed cheese every day in the evening over 7 days), or a gluten/emulsifier challenge ( 3-4 slices of bread)
| Study group | Role | What they receive |
|---|---|---|
| a milk fat or gluten challenge | Experimental | patients will regress to the first stage diet with either a milk fat /emulsifier or a gluten/emulsifier challenge over 7 days. Receives: Other: CDED + milk fat and gluten |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with calprotetctin elevation
Measured: day 14 or 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJan 2017
- Primary completion29 May 2022
- Study completion29 May 2022
Why it stopped: It is not possible to continue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Arie Levine, Wolfson Medical Center
- Investigators
- Arie Levine, MD, Study chair, Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930564
- Sponsor's protocol ID
- 0186-16-WOMC
- Status last verified
- May 2022
- First submitted
- 9 Oct 2016
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Challenge Study: A Dietary Personalization Protocol for Patients With Crohn's Disease and Deep Remission
- ClinicalTrials.gov ID
- NCT02930564
- Acronym / sponsor ID
- 0186-16-WOMC
- Conditions
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is not possible to continue the study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- 29 May 2022 (actual)
- Study completion
- 29 May 2022 (actual)
- First posted
- 12 Oct 2016 (estimated)
- 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.
The Challenge study is a prospective, open label, pilot trial in patients in deep remission on dietary maintenance therapy.
The purpose of this study is to determine whether they can consume some of the products that were eliminated from their diet, named the Crohn's Disease Exclusion Diet (CDED), and to evaluate if low dose exposure is harmful.
Detailed description
The investigators have previously hypothesized that Crohn's disease may occur via a sequence of events involving dysbiosis and genetically determined or environmentally acquired defects in innate immunity, and have further hypothesized that the mechanism of EEN for induction of remission acts by reducing exposure to dietary components that may cause an acquired bacterial clearance defect or generate dysbiosis.
Based on this premise, the investigators developed a new exclusion diet. This diet, named the Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. This diet was evaluated for induction of remission through week 12 and succeeded in inducing remission in 70% of 47 selected patients.
The investigators have now progressed to three randomized controlled trials to evaluate the diet in different populations with different disease severity, and the results from the first RCT demonstrate a high remission rate in the CDED arm. However , to date the investigators have used the same diet for all patients. The investigators are now encountering patients on the diet in deep remission, but the investigators do not know if they can consume some of the products ( such as milk fat and gluten) that were eliminated. The investigators therefore are starting to challenge our patients in deep remission with low dose exposure to evaluate if low dose exposure is harmful. The investigators wish to document this and obtain stool samples for calprotetctin and microbiome to investigate these patients at a microbiological level as well.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a milk fat or gluten challenge | Experimental | Other: CDED + milk fat and glutenpatients will regress to the first stage diet with either a milk fat /emulsifier or a gluten/emulsifier challenge over 7 days. |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Established diagnosis of Crohn's disease.
- Patients in sustained remission with PCDAI 0 > 6 months
- Ages 8-20
- Normal CRP (CRP<0.5), normal Calprotectin (<100)
- Patients with uncomplicated disease
Key exclusion criteria (6 listed)
- Patients with active disease (PCDAI >10)
- Pregnancy
- Patients with complicated disease (B2, B3)
- Patients with recent onset use of an immunomodulator <12 weeks, or dose change in past 12 weeks.
- Patients with current use of biologics.
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 |
|---|---|---|
| CDED + milk fat and glutenAlso: Crohn's Disease Exclusion Diet (CDED)CDED phase 1- induction phase a milk fat /emulsifier challenge (one scoop of ice cream and one slice of yellow processed cheese every day in the evening over 7 days), or a gluten/emulsifier challenge ( 3-4 slices of bread) | Other | a milk fat or gluten challenge |
Primary outcome
number of patients with calprotetctin elevation
Time frame: day 14 or 21
Results and safety
The study was stopped early (reason given: It is not possible to continue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Arie Levine, MD study chair
Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDED + milk fat and gluten in people with Crohn's Disease, run by Wolfson Medical Center at 1 site in Israel.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study was stopped early (reason given: It is not possible to continue the study). Results are not available in the source record.
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?
number of patients with calprotetctin elevation (time frame: day 14 or 21). 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 1 Jun 2022.