Crohn Disease of IntestineMILESTONE-CDNCT04612621
MILESTONE-CD -A Prospective Multiomic Inception Real -Life Study To Evaluate Predictors of Disease Outcomes & respoNse to Biologic Treatment in Crohn's Disease
A study testing combination of diagnostic tests in people with Crohn Disease of Intestine, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Crohn's' disease (CD) is a lifelong-chronic inflammatory condition of the digestive tract. CD frequently manifests during the 2nd or 3rd decade; prolonged disease duration frequently results in major structural complications such as strictures and fistulae, leading to surgery for control of complications in at least… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease of Intestine
- What is being tested?
- combination of diagnostic tests
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2020to 1 Nov 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Crohn's disease
- Start of first-line biological therapy
Who cannot join
- Previous biologic therapy
- Previous surgery
Trial locations and contacts
1 site in 1 country.
About this study
Crohn's' disease (CD) is a lifelong-chronic inflammatory condition of the digestive tract. CD frequently manifests during the 2nd or 3rd decade; prolonged disease duration frequently results in major structural complications such as strictures and fistulae, leading to surgery for control of complications in at least 30% of the patients. The course of disease is extremely diverse, ranging from a very mild disease to a devastating and incapacitating course. The burden of inflammatory bowel disease is growing each disease, reaching 400 billion USD for lifetime in US. In Israel, there are currently over 50000 IBD patients, with one of the highest incidences in the word, multiple treatment modalities and medications are available for Crohn's disease, however the efficacy is limited and the costs- very high. Furthermore, long-term exposure to some of the therapeutic agents poses an increased risk of infections and cancer.
Some of the major challenges in IBD include prediction of disease course (some patients will require early and aggressive treatment while others may just need observation and follow-up), and treatment personalization (right drug for the right patient at the right time). Unfortunately, individualized predictors of disease course and response to treatment are currently very limited. Some clues can be derived from imaging and endoscopy data, transcriptomics, genomic and microbiome, however those are still very premature and impractical. Moreover, large-scale studies with sophisticated predictive models that incorporate multilayered and multilayered clinical and omic data are severely lacking.
Read the detailed description
Goal:
Create comprehensive patient-multiomic profile (PRO-Visualosome-microbiome-transcriptome-pharmacokineticome) to develop algorithm-based personalized IBD therapy
Design Prospective observational cohort study.
Study aim To detect predictors of response to biologics using a layered multiomic approach
Cohort size Up to 140 patients in 2 years
Study duration -Patients will be followed up to 2 years (possible extension) or until treatment discontinuation or intestinal surgery
Study procedures All study procedures will be performed for the purpose of the study
Baseline
Disease activity using Harvey Bradshaw score at all timepoints and visits
- baseline PROS -PROMIS10/SIBDQ/IBD control/PRO2 using DATOS app
- colonoscopy with Intestinal biopsies
- Blood for transcriptomics
- Blood/serum for serum and cellular markers
- Stool for microbiome/metabolomics (if colonoscopy done- a rectal swab during colonoscopy will be performed)
- Pillcam CD following patency capsule - if failed patients still will be included and continue follow- up without capsule endoscopy
- MRE
- IUS
- Fecal calprotectin home kit with CALPROSMART
- Basic chemistry
- Joint US (if joint symptoms) Repeated assessment -every month
- PROMIS10/SIBDQ/IBD control/-via DATOS app (during the first 14-16 weeks- PRO2 will be evaluated weekly) Continuous monitoring (mobile device via DATOS app)
First follow-up visit (12-14 weeks)
- Calprotectin
- Microbiome
- Blood for transcriptomics
- Blood/serum for serum and cellular markers, drug levels, CRP
Every 3 months
- Home calprotectin (Calprosmart) +microbiome
Every 6 months
- Clinic visit
- Pillcam CD
- IUS
- Blood for transcriptomics
- Blood/serum for serum and cellular markers, drug levels, CRP
- Calprotectin (home +ELISA) + microbiome
Upon failure (need to switch medication -defined by treating physician) or end of study
- Clinic visit
- Calprotectin *Home +ELISA)
- Microbiome
- Serum for transriptomics, metabolomics
- Blood/serum for serum and cellular markers, drug levels, CRP
- Repeat Pillcam CD (if not done within 6 months)
- Repeat IUS +thermal imaging (if not done within 6 months)
- MRE
- Drug levels will be done at every infusion for IV drugs and every 6 months for SC biologics and at the end of induction (week 8-16)
- Conditions
- Crohn Disease of Intestine
- Being tested
- combination of diagnostic tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of diagnostic testsDiagnostic test
capsule endoscopy, MRE , intestinal ultrasound, fecal microbiota, blood and serum biomarkers as described
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of first biologic
cessation or switch of first biologic as per decision of the treating physician (documentation of change of therapy from the first biologic for any reason)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Nov 2020
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease of IntestineStudies 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
- Model description
- All enrolled patients will undergo similar interventions
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612621
- Sponsor's protocol ID
- SHEBA-20-7346-UK-CTIL
- Acronym
- MILESTONE-CD
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2020
- Last updated
- 7 Dec 2023
- 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MILESTONE-CD -A Prospective Multiomic Inception Real -Life Study To Evaluate Predictors of Disease Outcomes & respoNse to Biologic Treatment in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04612621
- Acronym / sponsor ID
- MILESTONE-CD / SHEBA-20-7346-UK-CTIL
- Conditions
- Crohn Disease of Intestine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 3 Nov 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.
Crohn's' disease (CD) is a lifelong-chronic inflammatory condition of the digestive tract. CD frequently manifests during the 2nd or 3rd decade; prolonged disease duration frequently results in major structural complications such as strictures and fistulae, leading to surgery for control of complications in at least 30% of the patients. The course of disease is extremely diverse, ranging from a very mild disease to a devastating and incapacitating course. The burden of inflammatory bowel disease is growing each disease, reaching 400 billion USD for lifetime in US. In Israel, there are currently over 50000 IBD patients, with one of the highest incidences in the word, multiple treatment modalities and medications are available for Crohn's disease, however the efficacy is limited and the costs- very high. Furthermore, long-term exposure to some of the therapeutic agents poses an increased risk of infections and cancer.
Some of the major challenges in IBD include prediction of disease course (some patients will require early and aggressive treatment while others may just need observation and follow-up), and treatment personalization (right drug for the right patient at the right time). Unfortunately, individualized predictors of disease course and response to treatment are currently very limited. Some clues can be derived from imaging and endoscopy data, transcriptomics, genomic and microbiome, however those are still very premature and impractical. Moreover, large-scale studies with sophisticated predictive models that incorporate multilayered and multilayered clinical and omic data are severely lacking.
Detailed description
Goal:
Create comprehensive patient-multiomic profile (PRO-Visualosome-microbiome-transcriptome-pharmacokineticome) to develop algorithm-based personalized IBD therapy
Design Prospective observational cohort study.
Study aim To detect predictors of response to biologics using a layered multiomic approach
Cohort size Up to 140 patients in 2 years
Study duration -Patients will be followed up to 2 years (possible extension) or until treatment discontinuation or intestinal surgery
Study procedures All study procedures will be performed for the purpose of the study
Baseline
Disease activity using Harvey Bradshaw score at all timepoints and visits
- baseline PROS -PROMIS10/SIBDQ/IBD control/PRO2 using DATOS app
- colonoscopy with Intestinal biopsies
- Blood for transcriptomics
- Blood/serum for serum and cellular markers
- Stool for microbiome/metabolomics (if colonoscopy done- a rectal swab during colonoscopy will be performed)
- Pillcam CD following patency capsule - if failed patients still will be included and continue follow- up without capsule endoscopy
- MRE
- IUS
- Fecal calprotectin home kit with CALPROSMART
- Basic chemistry
- Joint US (if joint symptoms) Repeated assessment -every month
- PROMIS10/SIBDQ/IBD control/-via DATOS app (during the first 14-16 weeks- PRO2 will be evaluated weekly) Continuous monitoring (mobile device via DATOS app)
First follow-up visit (12-14 weeks)
- Calprotectin
- Microbiome
- Blood for transcriptomics
- Blood/serum for serum and cellular markers, drug levels, CRP
Every 3 months
- Home calprotectin (Calprosmart) +microbiome
Every 6 months
- Clinic visit
- Pillcam CD
- IUS
- Blood for transcriptomics
- Blood/serum for serum and cellular markers, drug levels, CRP
- Calprotectin (home +ELISA) + microbiome
Upon failure (need to switch medication -defined by treating physician) or end of study
- Clinic visit
- Calprotectin *Home +ELISA)
- Microbiome
- Serum for transriptomics, metabolomics
- Blood/serum for serum and cellular markers, drug levels, CRP
- Repeat Pillcam CD (if not done within 6 months)
- Repeat IUS +thermal imaging (if not done within 6 months)
- MRE
- Drug levels will be done at every infusion for IV drugs and every 6 months for SC biologics and at the end of induction (week 8-16)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- All enrolled patients will undergo similar interventions
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Crohn's disease
- Start of first-line biological therapy
Key exclusion criteria (2 listed)
- Previous biologic therapy
- Previous surgery
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 |
|---|---|---|
| combination of diagnostic testscapsule endoscopy, MRE , intestinal ultrasound, fecal microbiota, blood and serum biomarkers as described | Diagnostic test | – |
Primary outcome
failure of first biologic
Time frame: 2 years
cessation or switch of first biologic as per decision of the treating physician (documentation of change of therapy from the first biologic for any reason)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease of Intestine
RecruitingObservational study
Ultrasound and Proteomics for Guselkumab Response Assessment in Crohn's Disease (UPGRADE).
Crohn's Disease of Both Small and Large Intestine
Not yet recruitingObservational study
Use of Water Ingestion in Small Intestine Ultrasound
Crohn Disease (CD), Intestine Ultrasonography
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of diagnostic tests in people with Crohn Disease of Intestine, run by Sheba 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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?
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?
failure of first biologic (time frame: 2 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 7 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.