Evaluation of Therapeutic Strategy to Prevent Crohn's Disease Endoscopic poSToperatIve recurreNce Based on earlY Dosage of Faecal Calprotectin (DESTINY II)

June 3, 2026 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU d'Amiens
        • Principal Investigator:
          • Mathurin FUMERY
        • Contact:
          • Lise Laclautre
      • Clermont-Ferrand, France
        • Recruiting
        • CHU de Clermont-Ferrand
        • Principal Investigator:
          • Anthony Buisson
        • Contact:
          • Lise Laclautre
      • Lille, France
        • Not yet recruiting
        • CHU de Lille
        • Principal Investigator:
          • Maria NACHURY
        • Contact:
          • Lise Laclautre
      • Lyon, France
      • Marseille, France
      • Montpellier, France
        • Not yet recruiting
        • CHU de Montpellier
        • Principal Investigator:
          • Romain ALTWEGG
        • Contact:
          • Lise Laclautre
      • Nice, France
      • Toulouse, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active arm
Early dosage of fecal calprotectin at 3 months
Biological: Early faecal calprotectin dosage
An early dosage of faecal calprotectin will be done for the active arm group.
No Intervention: Standard arm
Standard dosage of fecal calprotectin at 6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony Buisson, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AOI 2022 BUISSON (DESTINY II)
  • 2024-A02839-38 (Other Identifier: 2024-A02839-38)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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