Crohn Disease (CD)DESTINY IINCT06972901
Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
A study testing Early faecal calprotectin dosage in people with Crohn Disease (CD) and Ileocolic Resection, run by University Hospital, Clermont-Ferrand at 8 sites in France.
Trial summary
Crohn's disease (CD) (> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use of biotherapies, intestinal resections remain frequent (50% of patients over time). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD), Ileocolic Resection, Post-endoscopic Operative Reccurence
- What is being tested?
- Early faecal calprotectin dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesFrance
- Study dates
- 13 Oct 2025to 1 Mar 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an established diagnosis of CD according to ECCO guidelines
- Adult Crohn's disease (age ≥ 18 years)
- Having undergone ileal, colonic, or ileocolonic resection without residual macroscopic lesions
- With an anastomosis that can be reached by ileocolonoscopy
- With at least one of the following risk factors for endoscopic POR: active smoking, previous intestinal resection (before the current resection), length of resected small bowel > 30 cm, fistulizing phenotype (B3 according to the Montreal classification), exposure to at least two biotherapies before surgery
- No contraindication to ustekinumab treatment
- Patient capable of giving consent
- Patient covered by the French healthcare system
Who cannot join
- Permanent stoma
- Total colectomy
- Uncontrolled postoperative infectious complication
- Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age
- Refusal to participate in the study
- Persons deprived of their liberty by judicial or administrative decision
- Minors
- Vulnerable protected adults (under guardianship, curatorship, or legal protection)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
CHU d'Amiens
Amiens
Lise Laclautre
Mathurin FUMERY
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Anthony Buisson
- Not yet recruiting
CHU de Lille
Lille
Lise Laclautre
Maria NACHURY
- Not yet recruiting
HCL
Lyon
Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr
Stéphane NANCEY
- Not yet recruiting
AP-HM
Marseille
Lise Laclautre, promo_interne_drci@chu-clermontferrrand.fr
Lucas Guillo
- Not yet recruiting
CHU de Montpellier
Montpellier
Lise Laclautre
Romain ALTWEGG
- Not yet recruiting
Chu de Nice
Nice
Lise Laclautre, promo_interne_drci@hu-clermontferrand.fr
Adrien Nicolau
- Not yet recruiting
CHU de Toulouse
Toulouse
Lise LACLAUTRE, promo_interne_drci@chu-clermontferrand.fr
Cyrielle GILLETTA DE SAINT-JOSEPH
About this study
Crohn's disease (CD) (> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use of biotherapies, intestinal resections remain frequent (50% of patients over time). Unfortunately, surgery is not curative since 75% of patients experienced post-endoscopic operative recurrence (POR) (i.e., recurrence of ulcerations) during the first year after surgery. Prevention of endoscopic POR (defined as a Rutgeerts index ≥ i2) is essential because endoscopic POR is highly predictive of clinical POR (i.e., recurrence of CD-related symptoms): > 40% and > 80% within 5 years for a Rutgeerts index ≥ i2 or ≥ i3, respectively. The recommended management is to start treatment after surgery to avoid endoscopic POR, and to perform a colonoscopy at 6 months (M6) with therapeutic escalation if endoscopic POR. Despite anti-TNF or ustekinumab treatment, the endoscopic POR rate remains high (30-40% at M6) leading to > 40% clinical POR despite therapeutic escalation (90 mg/4 weeks with ustekinumab) potentially due to late therapeutic escalation. Innovative strategies are therefore needed to prevent endoscopic POR, such as the use of fecal calprotectin, a non-invasive biomarker associated with endoscopic CD activity. We have previously demonstrated that its variation between surgery and M3 allows for a value at M3 predictive of endoscopic POR at M6. In this study, we hypothesize, for the first time, that a strategy integrating fecal calprotectin measurement at M3 with earlier therapeutic escalation (M3 vs M6) in case of abnormal value or kinetics could decrease the rate of endoscopic POR at M6.
Read the detailed description
This is a prospective, open-label, multicenter, randomized, controlled clinical trial with two parallel arms evaluating an innovative approach to standard care in patients with Crohn's disease. All eligible patients will be offered the study consecutively by the principal investigator or any other co-investigator declared for the study.
During the pre-inclusion visit (weeks -4 to -0 before inclusion), after verification of inclusion and exclusion criteria and obtaining informed consent, blood tests and an abdominal ultrasound (if participating in the DESTINY-echo ancillary study) will be ordered (pre-biotherapy assessment, CRP) as well as a fecal calprotectin test.
After re-verification of inclusion and exclusion criteria, at the inclusion visit (V0), patients will be randomized to the two study arms (standard arm vs. active arm). Randomization will be stratified by center and number of risk factors. The outcome of this randomization will be known to both the investigator and the patient.
The reference arm will be based on daily practice, i.e., regular follow-up (weeks 0 and 24) with fecal calprotectin measurement at week 10.
Each patient will be seen with a stool sample at weeks 0, 10, and 24. However, the results will only be provided for patients in the active arm. The fecal calprotectin measurement result at week 10 for patients in the standard arm will not be known during the study but may be disclosed upon patient completion of the study.
Stool samples will be transferred to the biochemistry laboratory at Clermont-Ferrand University Hospital under conditions adapted for the centralized measurement of fecal calprotectin levels (blinded to clinical data). In the active arm, if a fecal calprotectin measurement is abnormal (> 100 µg/g at week 10 or a variation between weeks 0 and 10 > 50 µg/g), the investigator will be notified by an electronic alert, and therapeutic intensification will be implemented at week 12. Fecal calprotectin measurement will be standardized and performed using the same test in all patients. All colonoscopies will be performed and videotaped for both arms at week 24. They will be centrally analyzed by two independent experts, blinded to the strategy, and scored according to the Rutgeerts index to determine the presence of postoperative endoscopic recurrence.
At the end of the study, the patient will be treated and monitored according to current recommendations and at the investigator's discretion.
- Being tested
- Early faecal calprotectin dosage
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early faecal calprotectin dosageBiological
An early dosage of faecal calprotectin will be done for the active arm group.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Active comparator | Early dosage of fecal calprotectin at 3 months Receives: Biological: Early faecal calprotectin dosage |
| Standard arm | No intervention | Standard dosage of fecal calprotectin at 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative endoscopic recurrence
Postoperative endoscopic recurrence at 6 months, defined by a Rutgeerts index ≥ i2.
This primary endpoint will be defined by endoscopic procedure at 6 months postoperatively.
Measured: 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start13 Oct 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Buisson, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972901
- Sponsor's protocol ID
- AOI 2022 BUISSON (DESTINY II)
- Other IDs
- 2024-A02839-38
- Acronym
- DESTINY II
- Status last verified
- Dec 2025
- First submitted
- 7 May 2025
- Last updated
- 5 Jun 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin
- ClinicalTrials.gov ID
- NCT06972901
- Acronym / sponsor ID
- DESTINY II / AOI 2022 BUISSON (DESTINY II)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 15 May 2025 (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) (> 200,000 patients in France) is a chronic inflammatory disease that can lead to progression of intestinal destruction and impaired quality of life. Despite the widespread use of biotherapies, intestinal resections remain frequent (50% of patients over time). Unfortunately, surgery is not curative since 75% of patients experienced post-endoscopic operative recurrence (POR) (i.e., recurrence of ulcerations) during the first year after surgery. Prevention of endoscopic POR (defined as a Rutgeerts index ≥ i2) is essential because endoscopic POR is highly predictive of clinical POR (i.e., recurrence of CD-related symptoms): > 40% and > 80% within 5 years for a Rutgeerts index ≥ i2 or ≥ i3, respectively. The recommended management is to start treatment after surgery to avoid endoscopic POR, and to perform a colonoscopy at 6 months (M6) with therapeutic escalation if endoscopic POR. Despite anti-TNF or ustekinumab treatment, the endoscopic POR rate remains high (30-40% at M6) leading to > 40% clinical POR despite therapeutic escalation (90 mg/4 weeks with ustekinumab) potentially due to late therapeutic escalation. Innovative strategies are therefore needed to prevent endoscopic POR, such as the use of fecal calprotectin, a non-invasive biomarker associated with endoscopic CD activity. We have previously demonstrated that its variation between surgery and M3 allows for a value at M3 predictive of endoscopic POR at M6. In this study, we hypothesize, for the first time, that a strategy integrating fecal calprotectin measurement at M3 with earlier therapeutic escalation (M3 vs M6) in case of abnormal value or kinetics could decrease the rate of endoscopic POR at M6.
Detailed description
This is a prospective, open-label, multicenter, randomized, controlled clinical trial with two parallel arms evaluating an innovative approach to standard care in patients with Crohn's disease. All eligible patients will be offered the study consecutively by the principal investigator or any other co-investigator declared for the study.
During the pre-inclusion visit (weeks -4 to -0 before inclusion), after verification of inclusion and exclusion criteria and obtaining informed consent, blood tests and an abdominal ultrasound (if participating in the DESTINY-echo ancillary study) will be ordered (pre-biotherapy assessment, CRP) as well as a fecal calprotectin test.
After re-verification of inclusion and exclusion criteria, at the inclusion visit (V0), patients will be randomized to the two study arms (standard arm vs. active arm). Randomization will be stratified by center and number of risk factors. The outcome of this randomization will be known to both the investigator and the patient.
The reference arm will be based on daily practice, i.e., regular follow-up (weeks 0 and 24) with fecal calprotectin measurement at week 10.
Each patient will be seen with a stool sample at weeks 0, 10, and 24. However, the results will only be provided for patients in the active arm. The fecal calprotectin measurement result at week 10 for patients in the standard arm will not be known during the study but may be disclosed upon patient completion of the study.
Stool samples will be transferred to the biochemistry laboratory at Clermont-Ferrand University Hospital under conditions adapted for the centralized measurement of fecal calprotectin levels (blinded to clinical data). In the active arm, if a fecal calprotectin measurement is abnormal (> 100 µg/g at week 10 or a variation between weeks 0 and 10 > 50 µg/g), the investigator will be notified by an electronic alert, and therapeutic intensification will be implemented at week 12. Fecal calprotectin measurement will be standardized and performed using the same test in all patients. All colonoscopies will be performed and videotaped for both arms at week 24. They will be centrally analyzed by two independent experts, blinded to the strategy, and scored according to the Rutgeerts index to determine the presence of postoperative endoscopic recurrence.
At the end of the study, the patient will be treated and monitored according to current recommendations and at the investigator's discretion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Active comparator | Biological: Early faecal calprotectin dosageEarly dosage of fecal calprotectin at 3 months |
| Standard arm | No intervention | –Standard dosage of fecal calprotectin at 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with an established diagnosis of CD according to ECCO guidelines
- Adult Crohn's disease (age ≥ 18 years)
- Having undergone ileal, colonic, or ileocolonic resection without residual macroscopic lesions
- With an anastomosis that can be reached by ileocolonoscopy
- With at least one of the following risk factors for endoscopic POR: active smoking, previous intestinal resection (before the current resection), length of resected small bowel > 30 cm, fistulizing phenotype (B3 according to the Montreal classification), exposure to at least two biotherapies before surgery
Key exclusion criteria (8 listed)
- Permanent stoma
- Total colectomy
- Uncontrolled postoperative infectious complication
- Pregnant or breastfeeding women: a pregnancy test will be performed for women of childbearing age
- Refusal to participate in the study
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 |
|---|---|---|
| Early faecal calprotectin dosageAn early dosage of faecal calprotectin will be done for the active arm group. | Biological | Active arm |
Primary outcome
Postoperative endoscopic recurrence
Time frame: 6 months post-operative
Postoperative endoscopic recurrence at 6 months, defined by a Rutgeerts index ≥ i2. This primary endpoint will be defined by endoscopic procedure at 6 months postoperatively.
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 5 Jun 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.
Anthony Buisson principal investigator
University Hospital, Clermont-Ferrand
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early faecal calprotectin dosage in people with Crohn Disease (CD) and Ileocolic Resection, run by University Hospital, Clermont-Ferrand at 8 sites in France.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Jun 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 France. 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?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative endoscopic recurrence (time frame: 6 months post-operative). 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 5 Jun 2026.